Imatinib Teva B.V. 100 mg film-coated tablets Imatinib – patient leaflet, side effects, dosage

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

Imatinib Teva B.V. 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 B.V. is a treatment 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.

In adult patients, Imatinib Teva B.V. is intended for use in the most advanced phase of the disease (blast crisis). In children and adolescents, Imatinib Teva B.V. can be used in different phases of the disease (chronic, accelerated phase and blast crisis).

Imatinib Teva is also a treatment for adults and children for:

• 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 B.V. inhibits the growth of these cells.

inib Teva B.V. 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 B.V. 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 B.V. 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 B.V. 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 B.V. works or why this medicine has been prescribed for you, ask your doctor.

ion 6).

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

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

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

Do not take Imatinib Teva B.V.

• if you are allergic to imatinib or any of the other ingredients of this medicine (liste

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

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 B.V.:

• if you have or have ever had a liver, kidney or heart proble id has been removed.

. This is because Imatinib Teva B.V.

• if you are taking the medicine levothyroxine because yo if you have ever had or might now have a hepatitis B in 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 any of these apply to you, tell your doctor before taking Imatinib Teva B.V.

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

While you are taking Imatinib Teva B.V. 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 B.V. is also a treatment for children 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 B.V. may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva B.V.

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 B.V. when taken together. They may increase or decrease the effect of Imatinib Teva B.V., either leading to increased side effects or making Imatinib Teva B.V. less effective. Imatinib Teva B.V. 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 B.V. 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 B.V. during pregnancy.

Women who might become pregnant are advised to use effective contraception during treatment.

matinib Teva

Do not breast-feed during the treatment with Imatinib Teva B.V.

Patients who are concerned about their fertility while taking Imatinib Teva B.V. 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, or use any tools or machines until you are feeling well again.

3. How to take Imatinib Teva B.V.

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

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

Do not stop taking Imatinib Teva B.V. 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 B.V. to take

Use in adults

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

If you are being treated for CML:

The usual starting dose is 600 mg to be taken as one 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 one capsule once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to 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.

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If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as one 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 one capsule once a day.

If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as one 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 one 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 B.V. to give to your child. The amount of Imatinib Teva B.V. given will depend on your child’s condition, body weight and height. The total daily dose in children 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 B.V.

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

• 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 B.V.

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

If you take more Imatinib Teva B.V. 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 B.V.

• 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 B.V. 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 B.V. 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 o 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 (eg. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).

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

Other side effects ma

r doctor straight away.

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

Headache or feeling tired.

Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.

Rash.

le cramps or joint, muscle or bone pain, during treatment with Imatinib Teva B.V. or after you stopped taking Imatinib Teva B.V.

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.
• 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 in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imatinib Teva B.V.

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 B.V. contains

• The active substance is imatinib (as mesilate).
• Each hard capsule of Imatinib Teva B.V. contains 400 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 B.V. looks like and contents of the pack

Imatinib Teva B.V. 400 mg hard capsules are non-transparent orange capsules with black marking 7630 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 23 mm long and 9 mm wide.

Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters. Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG United Kingdom

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, 2031GA Haarlem 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:

Tel: +39 02 89 17 98 1

Puh/Tel: +358 20 180 5900

Kûnpoç

Teva EXXaç A.E., EXXaSa

Tql: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

This leaflet was last revised in

United Kingdom

Teva UK Limited

Tel: +44 1977 628500

Latvija

UAB “Sicor Biotech” filiale Latvijâ

Tel: +371 673 23 666

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency we site: http://www.ema.europa.eu

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¹

Haematological response criteria (all responses to be confirmed after > 4 weeks):

CHR: In study 0102 [ANC > 1.5 x 10⁹/l, platelets > 100 x 10⁹/l, no blood blasts, BM blasts < 5% and no extramedullary disease]

NEL Same criteria as for CHR but ANC > 1 x 10⁹/l and platelets > 20 x 10⁹/l

RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver.

BM = bone marrow, PB = peripheral blood

²

Cytogenetic response criteria:

A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)

³

Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study