Imatinib medac - patient leaflet, side effects, dosage

What Imatinib medac is and what it is used for

Imatinib medac is also a treatment for children and adolescents for:

Newly diagnosed CML for whom bone marrow transplantation is not considered as the first line of treatment;

CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase. Accelerated phase is an intermediate phase among the chronic phase and the onset of blast crisis; it is considered as the first manifestation of resistance to therapy.

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

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

Children and adolescents

Imatinib medac 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 and adolescents with Ph-positive ALL.

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

Other medicines and Imatinib medac

Tell your doctor, pharmacist or nurse 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 medac when taken together. They may increase or decrease the effect of Imatinib medac, either leading to increased side effects or making Imatinib medac less effective. Imatinib medac 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 medac 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 medac during pregnancy.
• Women who might become pregnant are advised to use effective contraception during treatment. rv

Do not breast-feed during the treatment with Imatinib medac as there is the distribution of imatinib into the breast milk.

Patients who are concerned about their fertility while taking Imatinib m 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 medac contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Imatinib medacYour doctor has prescribed Imatimedac can help you to figh However, always take this important that you do this doctor, pharmacist or nursthiib medac because you suffer from a serious condition. Imatinib ondition.ne exactly as your doctor, pharmacist or nurse has told you. It is as your doctor, pharmacist or nurse tells you to. Check with yourf you are not sure.

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

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

The usual starting dose in treatment in CML in blast crisis is 600 mg, to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) 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, you should take 1 capsule of 400 mg in the morning and 1 capsule of 400 mg in the evening.

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

The starting dose is 600 mg to be taken as 6 capsules of 100 mg (or 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 of 400 mg onc e 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, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of 400 mg in the evening.

Use in children and adolescents

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

• Take Imatinib medac with a meal. This will help protect you from stomach problems when taking Imatinib medac.
• 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 mineral water or apple juice.
• If you are a woman who is pregnant or might get pregnant and are trying to open the capsules for your children or another patient unable to swallow, 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 medac

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

If you take more Imatinib medac 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 medac

• 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 medac may cause your body to retain water (severe fluid retention). Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib medac 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 e

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 stool gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney pr
• 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 ynaud’s syndrome).

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

an abnormal heart rhythm (signs of changes in the amount of

ling sick (nausea).

a fever, red-brown urine, pain or weakness in your muscles (signs of

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 phosphorus 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.

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 medac treatment or after you have stopped taking Imatinib medac
• 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.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

5. How to store Imatinib medac

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 blister and carton after EXP.

Do not store above 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 informationWhat Imatinib medac contains The active substance is imatinib (as mesilate).

Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).

Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).

The other ingredients are crospovidone (type A), lactose monohydrate, magnesium stearate. The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).

The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).

What Imatinib medac looks like and contents of the pack

Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap.

Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap.

Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.

Imatinib medac 400 mg capsules are supplied in packs containing 30 capsules in blisters.

Marketing Authorisation Holder medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6 22880 Wedel

Germany

Pabianickie Zaklady Farmaceutyc Marszalka Józefa Pilsudskiego 5 95–200 Pabianice Poland

Other sources of information

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

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