B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Imatinib Teva 100 mg film-coated tablets imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.

You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many tablets of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 4 tablets once a day,

• - 600 mg to be taken as 6 tablets once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 4 tablets once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 6 tablets once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 4 tablets once a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 tablet once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.

Use in children and adolescents

The doctor will tell you how many tablets of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva.

• - Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

• Use about 50 ml for each 100 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass.

The tablet can be divided into equal doses.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).

Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.

Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of

liver problems).

• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• Eye pain or deterioration in vision, bleeding in the eyes.
• Pain in your hips or difficulty walking.
• Numb or cold toes and fingers (signs of Raynaud’s syn­drome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Bruising.
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as round your ankles or puffy eyes.
• Weight gain.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).

• – The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate.

• – The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).

What Imatinib Teva looks like and contents of the pack

Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side. The tablet is debossed with “IT” and “1” at each side of the score line. The tablets are approximately 9 mm in diameter.

Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.

Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 20×1, 60×1, 120×1 or 180×1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31–546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tel/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +353 19127700
Deutschland AbZ-Pharma GmbH Tel: +49 73140205	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXXáóa Specifar A.B.E.E. Tip.: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +353 19127700	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EMáSa

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiäle Latvijä

Tel: +371 67323666

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Imatinib Teva 400 mg film-coated tablets imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many tablets of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 1 tablet once a day,

• - 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 4 tablets of

400 mg once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 1 tablet once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 4 tablets of 400 mg once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 1 tablet once a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (2 tablets), to be taken as 1 tablet in the morning and a second tablet in the evening.

Use in children and adolescents

The doctor will tell you how many tablets of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva

• - Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

• Use about 200 ml for each 400 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass.

The tablet can be divided into equal doses.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.

Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• Eye pain or deterioration in vision, bleeding in the eyes.
• Pain in your hips or difficulty walking.
• Numb or cold toes and fingers (signs of Raynaud’s syn­drome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Bruising.
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as round your ankles or puffy eyes.
• Weight gain.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).

• – The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate.

• – The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).

What Imatinib Teva looks like and contents of the pack

Imatinib Teva 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side. The tablet is debossed with “IT” and “4” at each side of the score line. The tablets are approximately 20 mm long and 10 mm wide.

Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.

Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30×1or 90×1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31–546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +353 19127700
Deutschland AbZ-Pharma GmbH Tel: +49 73140205	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXXáóa Specifar A.B.E.E. Tip.: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +353 19127700	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland	Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EMáSa

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiale Latvijä

Tel: +371 67323666

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Imatinib Teva 100 mg hard capsules imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby

ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many capsules of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 4 capsules once a day,

• - 600 mg to be taken as 6 capsules once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 4 capsules onc e a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 6 capsules once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 4 capsules onc e a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 capsule once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.

Use in children and adolescents

The doctor will tell you how many capsules of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva.

• - Swallow the capsules whole with a large glass of water. Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).

• – If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.

• – If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation. You should wash your hands immediately after opening the capsules.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.
• Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).

Cough, having difficulty breathing or painful breathing (signs of lung problems).

Feeling light-headed, dizzy or fainting (signs of low blood pressure).

Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).

Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems). Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).

Severely decreased urine output, feeling thirsty (signs of kidney problems).

Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).

Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain). Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).

Eye pain or deterioration in vision, bleeding in the eyes.

Pain in your hips or difficulty walking.

Numb or cold toes and fingers (signs of Raynaud’s syn­drome).

Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).

Difficulty hearing.

Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).

Bruising.

Stomach pain with feeling sick (nausea).

Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).

Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb). Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).

Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as round your ankles or puffy eyes.
• Weight gain.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Store below 30 °C.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).

• – The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous. The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172). The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.

What Imatinib Teva looks like and contents of the pack

Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap. The content of the capsule is white to light yellow granulated powder. The capsules are approximately 19 mm long and 7 mm wide.

Imatinib Teva 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters. Imatinib Teva 100 mg hard capsules are available in pack sizes of 20×1, 60×1, 120×1 or 180×1 hard capsules in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31–546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +353 19127700
Deutschland AbZ-Pharma GmbH Tel: +49 73140205	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXXáóa Specifar A.B.E.E. Tip.: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +353 19127700	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Teva Finland Oy Finnland	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Sími: +358 201805900

Italia

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EXXáSa

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiale Latvijä

Tel: +371 67323666

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Imatinib Teva 400 mg hard capsules imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.

You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many capsules of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 1 capsule once a day,

• - 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 1 capsule once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a second capsule in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 1 capsule once a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (2 capsules), to be taken as 1 capsule in the morning and a second capsule in the evening.

Use in children and adolescents

The doctor will tell you how many capsules of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva.

• - Swallow the capsules whole with a large glass of water. Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).

• – If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.

• – If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation. You should wash your hands immediately after opening the capsules.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.

Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of

liver problems).

• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• Eye pain or deterioration in vision, bleeding in the eyes.
• Pain in your hips or difficulty walking.
• Numb or cold toes and fingers (signs of Raynaud’s syn­drome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Bruising.
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Store below 30 °C.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).

• – The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal

What Imatinib Teva looks like and contents of the pack

Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side. The tablet is debossed with “IT” and “1” at each side of the score line. The tablets are approximately 9 mm in diameter.

Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.

Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 20×1, 60×1, 120×1 or 180×1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31–546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tel/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +353 19127700
Deutschland AbZ-Pharma GmbH Tel: +49 73140205	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXXáóa Specifar A.B.E.E. Tip.: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +353 19127700	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EMáSa

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiäle Latvijä

Tel: +371 67323666

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Imatinib Teva 400 mg film-coated tablets imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many tablets of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 1 tablet once a day,

• - 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 4 tablets of

400 mg once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 1 tablet once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 4 tablets of 400 mg once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 1 tablet once a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (2 tablets), to be taken as 1 tablet in the morning and a second tablet in the evening.

Use in children and adolescents

The doctor will tell you how many tablets of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva

• - Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

• Use about 200 ml for each 400 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass.

The tablet can be divided into equal doses.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.

Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• Eye pain or deterioration in vision, bleeding in the eyes.
• Pain in your hips or difficulty walking.
• Numb or cold toes and fingers (signs of Raynaud’s syn­drome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Bruising.
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as round your ankles or puffy eyes.
• Weight gain.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).

• – The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate.

• – The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).

What Imatinib Teva looks like and contents of the pack

Imatinib Teva 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side. The tablet is debossed with “IT” and “4” at each side of the score line. The tablets are approximately 20 mm long and 10 mm wide.

Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.

Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30×1or 90×1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31–546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +353 19127700
Deutschland AbZ-Pharma GmbH Tel: +49 73140205	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXXáóa Specifar A.B.E.E. Tip.: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +353 19127700	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland	Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EMáSa

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiale Latvijä

Tel: +371 67323666

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Imatinib Teva 100 mg hard capsules imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby

ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many capsules of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 4 capsules once a day,

• - 600 mg to be taken as 6 capsules once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 4 capsules onc e a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 6 capsules once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 4 capsules onc e a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 capsule once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.

Use in children and adolescents

The doctor will tell you how many capsules of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva.

• - Swallow the capsules whole with a large glass of water. Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).

• – If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.

• – If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation. You should wash your hands immediately after opening the capsules.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.
• Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).

Cough, having difficulty breathing or painful breathing (signs of lung problems).

Feeling light-headed, dizzy or fainting (signs of low blood pressure).

Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).

Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems). Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).

Severely decreased urine output, feeling thirsty (signs of kidney problems).

Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).

Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain). Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).

Eye pain or deterioration in vision, bleeding in the eyes.

Pain in your hips or difficulty walking.

Numb or cold toes and fingers (signs of Raynaud’s syn­drome).

Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).

Difficulty hearing.

Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).

Bruising.

Stomach pain with feeling sick (nausea).

Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).

Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb). Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).

Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as round your ankles or puffy eyes.
• Weight gain.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Store below 30 °C.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).

• – The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous. The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172). The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.

What Imatinib Teva looks like and contents of the pack

Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap. The content of the capsule is white to light yellow granulated powder. The capsules are approximately 19 mm long and 7 mm wide.

Imatinib Teva 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters. Imatinib Teva 100 mg hard capsules are available in pack sizes of 20×1, 60×1, 120×1 or 180×1 hard capsules in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Merckle GmbH

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31–546 Krakow

Poland

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +353 19127700
Deutschland AbZ-Pharma GmbH Tel: +49 73140205	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXXáóa Specifar A.B.E.E. Tip.: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +353 19127700	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Teva Finland Oy Finnland	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Sími: +358 201805900

Italia

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EXXáSa

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiale Latvijä

Tel: +371 67323666

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Imatinib Teva 400 mg hard capsules imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Imatinib Teva is and what it is used for

• 2. What you need to know before you take Imatinib Teva

• 3. How to take Imatinib Teva

• 4. Possible side effects

• 5. How to store Imatinib Teva

• 6. Contents of the pack and other information

1. What Imatinib Teva is and what it is used for

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white

cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.

• - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instruc­tions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• – if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions

Talk to your doctor before taking Imatinib Teva:

• – if you have or have ever had a liver, kidney or heart problem.

• – if you are taking the medicine levothyroxine because your thyroid has been removed.

• – if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.

You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.

• – Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults

Your doctor will tell you exactly how many capsules of Imatinib Teva to take.

• – If you are being treated for CML:

Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• - 400 mg to be taken as 1 capsule once a day,

• - 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg, to be taken as 1 capsule once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a second capsule in the evening.

• - If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 1 capsule once a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.

• - If you are being treated for DFSP:

The dose is 800 mg per day (2 capsules), to be taken as 1 capsule in the morning and a second capsule in the evening.

Use in children and adolescents

The doctor will tell you how many capsules of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• - Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva.

• - Swallow the capsules whole with a large glass of water. Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).

• – If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.

• – If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation. You should wash your hands immediately after opening the capsules.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• – If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

• – Then continue with your normal schedule.

• – Do not take a double dose to make up a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

• Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.

Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of

liver problems).

• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• Eye pain or deterioration in vision, bleeding in the eyes.
• Pain in your hips or difficulty walking.
• Numb or cold toes and fingers (signs of Raynaud’s syn­drome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Bruising.
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.

If any of these affects you severely, tell your doctor.

Common (may affect up to 1 in 10 people):

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Store below 30 °C.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imatinib Teva contains

• – The active substance is imatinib (as mesilate).

• – Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).

• – The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal