Imatinib Actavis - patient leaflet, side effects, dosage

- 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 Actavis is and what it is used for

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

• 3. How to take Imatinib Actavis

• 4. Possible side effects

• 5. How to store Imatinib Actavis

• 6. Contents of the pack and other information

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

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

• - 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 Actavis inhibits the growth of these cells.

Imatinib Actavis 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 Actavis 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 Actavis inhibits the growth of these cells in a certain subtype of these diseases.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Actavis 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 Actavis works or why this medicine has been prescribed for you, ask your doctor.

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

Imatinib Actavis 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 Actavis

• – 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 Actavis.

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 Actavis:

• – 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 Actavis

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 Actavis, 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 Actavis.

You may become more sensitive to the sun while taking Imatinib Actavis. 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 Actavis, tell your doctor straight away if you put on weight very quickly. Imatinib Actavis may cause your body to retain water (severe fluid retention).

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

Children and adolescents

Imatinib Actavis 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 and HES/CEL.

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

Other medicines and Imatinib Actavis

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 Actavis when taken together. They may increase or decrease the effect of Imatinib Actavis, either leading to increased side effects or making Imatinib Actavis less effective. Imatinib Actavis 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 Actavis 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 Actavis 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 Actavis and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Actavis 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.

Imatinib Actavis contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

3. How to take Imatinib Actavis

Your doctor has prescribed Imatinib Actavis because you suffer from a serious condition. Imatinib Actavis 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 Actavis 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 Actavis to take

Use in adults

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

• - If you are being treated for CML:

The usual starting dose is 600 mg to be taken as 12 capsules once a day.

Your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg (16 capsules), you should take 8 capsules in the morning and 8 capsules in the evening.

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

The starting dose is 600 mg to be taken as 12 capsules once a day.

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

The starting dose is 400 mg, to be taken as 8 capsules once a day.

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

The starting dose is 100 mg, to be taken as 2 capsules once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 8 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 (16 capsules), to be taken as 8 capsules in the morning and

• 8 capsules in the evening.

Use in children and adolescents

The doctor will tell you how many capsules of Imatinib Actavis to give to your child. The amount of Imatinib Actavis 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 Actavis

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

• - 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 Actavis

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

If you take more Imatinib Actavis 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 Actavis

• – 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 Actavis may cause your body to retain water (severe fluid retention).

• – Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Actavis 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 (eg. 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 imatinib treatment or after you have stopped taking imatinib.

• – Swelling such as round your ankles or puffy eyes.

• – Weight gain.

If any of these affect 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 affect 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 affect 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 Actavis

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 that month.

Do not store above 25°C. Store in the original package in order to protect from moisture.

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 Actavis contains

• – The active substance is imatinib (as mesilate). Each capsule contains 50 mg imatinib (as mesilate).

• – The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).

What Imatinib Actavis looks like and contents of the pack

Hard capsule with light yellow cap and light yellow body imprinted with 50 mg in black ink.

The capsule contains light yellow powder.

Pack sizes:

The capsules are supplied in aluminium blister packs of 30 or 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76–78,

Hafnarfjordur

Iceland

Manufacturer

S.C. Sindan-Pharma S.R.L.

11 Ion Mihalache Blvd

Bucharest

Romania

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

Belgie/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Efcnrapua 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: +44 2075407117
Deutschland ratiopharm GmbH Tel: +49 73140202	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EZZáSa Specifar A.B.E.E. Tql: +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: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Teva Pharma Iceland ehf. Sími: +354 5503300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Italia Teva Italia S.r.l. Tel: +39 028917981	Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900
Kùnpoç Specifar A.B.E.E. EXXáSa	Sverige Teva Sweden AB Tel: +46 42121100

TnX: +30 2118805000

Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666

United Kingdom (Northern Ireland) Accord Healthcare Ireland Ltd. Ireland Tel: +353 214619040

This leaflet was last revised in

Other sources of information

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