Imavec 400 mg Capsules

IMAVEC is a medicine containing an active substance called imatinib. IMAVEC works by inhibiting the abnormal or uncontrolled growth of cells involved in some types of cancer.

Do NOT take IMAVEC if you are:

• Hypersensitive (allergic) to imatinib or any of the other ingredients of IMAVEC.
• Pregnant or breastfeeding (see ʺ Pregnancy and breastfeeding ʺ).

Take special care with IMAVEC:

Before using IMAVEC you should speak to your doctor if you:

• Are currently using simvastatin for the treatment of high blood cholesterol levels.
• Are taking paracetamol for fever or pain, including over-the-counter preparations.
• Are taking rifampicin (for tuberculosis), ketoconazole (for fungus infections), ciclosporin (for prevention of rejection in kidney, liver and heart transplants) or warfarin (for prevention of blood clotting).
• Have liver function problems.
• Have kidney disease or disease that impairs the working of the kidney.
• Have heart disease.
• Are taking the medicine levothyroxine because your thyroid has been removed.
• Have ever had or might now have a hepatitis B infection inform you doctor. IMAVEC 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. You will have to undergo regular blood tests to evaluate white blood cell and platelet counts. Platelets play a very important role in blood clotting. Your doctor will also regularly check your liver function. You will have to undergo periodic blood tests to evaluate your blood cell counts, blood uric acid levels, blood electrolyte levels (e.g. potassium), and liver and kidney function. Your doctor will also monitor your blood pressure levels as treatment with IMAVEC may increase or decrease your blood pressure.

Do not share medicines prescribed for you with any other person. Always take IMAVEC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

IMAVEC should be taken once daily with a meal and a large glass of water. Your doctor will determine the most appropriate dosage. He/she may decide to alter your dosage if you develop adverse reactions, such as impairment of liver function or low white blood cell and low platelet counts.

If you are unable to swallow the capsules, you can dissolve them in a glass of water or apple juice. Stir the mixture until the content of the capsule have been dissolved completely. Drink everything in the glass straight away. If you are pregnant the handling of opening IMAVEC capsules may be harmful to your baby. If you have the impression that the effect of IMAVEC is too strong or too weak, talk to your doctor or pharmacist.

Children: IMAVEC should not be used in children.

Elderly patients: Elderly patients do not require specific dosage adjustments; however, your doctor may decide to alter your dosage depending on your liver function.

Impaired liver function: Cases of liver failure including death have occurred in patients treated with IMAVEC. (see Possible Side Effects).

If you take more IMAVEC than you should: In the event of an overdosage, or if someone else has taken your medicine by mistake, you, or this other person, may experience side effects such as those listed below. In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take IMAVEC: Always take IMAVEC as prescribed. If you miss a dose, take it as soon as you remember. However, if it is close to your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the forgotten individual dose. It is important to take IMAVEC regularly.

IMAVEC can have side effects. Not all side effects reported for IMAVEC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IMAVEC, please consult your doctor, pharmacist or other healthcare professional for advice.

The most frequently experienced side effects of IMAVEC include mild nausea, vomiting, diarrhoea, muscle pain, muscle cramps, and skin rash. Another common side-effect is fluid retention with swelling of the eyelids or lower limbs. If any of the following happens, stop taking IMAVEC and tell your doctor immediately or go to the casualty department at your nearest hospital:

Frequent:

• Severe swelling of the whole body.

Less frequent:

• Symptoms suggestive of stroke, such as weakness in a limb, difficulty speaking or alteration in consciousness.
• Swelling of the limbs, face or abdomen with rapid heart rate, extreme tiredness and shortness of breath.
• Any blistering skin rash.
• Skin rash, itching, red discolouration of the skin, dry skin, hair loss, breaking of your nails, night sweats, increased sweating, hives, rash or darker pigmentation of sun-exposed skin, decreased skin pigmentation, or inflammation or cracking of the corners of the mouth or lips.

Frequency unknown:

• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to IMAVEC. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent:

• Fever, cough with sputum production, difficulty breathing, shortness of breath, and extreme tiredness.
• Bleeding from the gums, easy bruising, or pin point red spots on the skin.
• Foul-smelling diarrhoea.

Store at or below 25 °C in the original pack. Protect from moisture. The blisters should not be removed from the carton until required for use. Do not use the medicine after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems, for example toilets.