What is it and how is it used?

Glivec 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.

Glivec 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.
Glivec is also a treatment for adults 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. Glivec inhibits the growth of these cells.
  • Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Glivec 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. Glivec 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. Glivec 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 Glivec works or why this medicine has been prescribed for you, ask your doctor.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Glivec 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 Glivec:

  • if you are allergic (hypersensitive) to imatinib or any of the other ingredients of Glivec listed in section 6. If this applies to you, tell your doctor without taking Glivec.

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

Take special care with Glivec

Before taking Glivec, tell your doctor:

  • 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 any of these apply to you, tell your doctor before taking Glivec.

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

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

Glivec 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. There is no experience in children with GIST.

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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 Glivec when taken together. They may increase or decrease the effect of Glivec, either leading to increased side effects or making Glivec less effective. Glivec may do the same to some other medicines.

Pregnancy and breast-feeding

  • Talk to your doctor before taking Glivec if you are pregnant, might become pregnant or are breast-feeding.
  • Glivec is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the possible risks of taking Glivec during pregnancy.
  • Women who might become pregnantare advised to use effective contraception during treatment.
  • Do not breast-feed during the treatment with Glivec.

Driving and using machines
You may feel dizzy 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.

How is it used?

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

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

Do not stop taking Glivec 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 to take

Use in adults
Your doctor will tell you exactly how many capsules of Glivec 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 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 (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 MDSMPD The starting dose is 400 mg, to be taken as 4 capsules once a day.

If you are being treated for HESCEL The starting dose is 100 mg, to be taken as one 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
The doctor will tell you how many capsules of Glivec to give to your child. The amount of Glivec given will depend on your child?s condition, body weight and height. The total daily dose in children must not exceed 800 mg. 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 Glivec

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

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

If you take more Glivec 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 Glivec

  • 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 product, ask your doctor or pharmacist.

What are possible side effects?

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

These side effects may occur with certain frequencies, which are defined as follows:

  • Very common: affects more than 1 patient in 10.
  • Common: affects 1 to 10 patients in 100.
  • Uncommon: affects 1 to 10 patients in 1,000.
  • Rare: affects 1 to 10 patients in 10,000.
  • Very rare: affects less than 1 patient in 10,000.
  • Not known: frequency cannot be estimated from the available data.
Some side effects may be serious. Tell your doctor straight away if you get any of the following:

Very common or common side effects:

- Rapid weight gain. Glivec may cause your body to retain water (severe fluid retention). - Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Glivec 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 or rare side effects 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, light-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. Pale skin, feeling tired and breathlessness and having dark urine signs of low levels of red blood cells. Eye pain or deterioration in vision. Pain in your hips or difficulty walking. Numb or cold toes and fingers signs of Raynauds syndrome. Sudden swelling and redness of the skin signs of a skin infection called cellulites. 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 andor joint discomfort associated with abnormal laboratory test results eg. high potassium, uric acid and phosphorous levels and low calcium levels in the blood. If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common side effects Headache or feeling tired. Feeling sick nausea, being sick vomiting, diarrhoea or indigestion. Rash. Muscle cramps or joint, muscle or bone pain. Swelling such as round your ankles or puffy eyes. Weight gain. If any of these affects you severely, tell your doctor.

Common side effects 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:

- 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.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the carton. Do not store above 30C. Store in the original package in order to protect from moisture. Do not use any pack that is damaged or shows signs of tampering.

Further information

What Glivec contains

  • The active substance is imatinib mesilate. Each capsule of Glivec contains 100 mg imatinib mesilate.
  • The other ingredients are microcrystalline cellulose, crospovidone, magnesium stearate and anhydrous colloidal silica. The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171). The printing ink is composed of red iron oxide (E172), shellac, soya lecithin.

What Glivec looks like and contents of the pack

Glivec 100 mg capsules are orange to greyish-orange and marked ?NVR SI?. They contain a white to yellow powder.

They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

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

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 375 4888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Romania SRL Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in

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