Imatinib Zentiva 400 mg filmomhulde tabletten

Imatinib Zentiva 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 Zentiva is a treatment for adults and children with 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 Zentiva is used to treat a late stage of Chronic Myeloid Leukaemia called “blast crisis.” In children and adolescents however it may be used to treat all stages of the illness.

If you have any questions about how Imatinib Zentiva works or why this medicine has been prescribed for you, ask your doctor.

Imatinib Zentiva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers.

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

Do not take Imatinib Zentiva:

- 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 Zentiva.

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 Zentiva:

• 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 Imatinib Zentiva.

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

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

Children and adolescents

Imatinib Zentiva is also a treatment for children with CML. There is no experience in children with CML below 2 years of age.

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

Other medicines and Imatinib Zentiva

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 Zentiva when taken together. They may increase or decrease the effect of Imatinib Zentiva, either leading to increased side effects or making Imatinib Zentiva less effective. Imatinib Zentiva may do the same to some other medicines.

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 Zentiva 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 Zentiva during pregnancy.
• Women who might become pregnant are advised to use effective contraception during treatment.
• Do not breast-feed during the treatment with Imatinib Zentiva.
• Patients who are concerned about their fertility while taking Imatinib Zentiva 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.

Your doctor has prescribed Imatinib Zentiva because you suffer from a serious condition. Imatinib Zentiva 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. You should check with your doctor or pharmacist if you are not sure.

Do not stop taking Imatinib Zentiva 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 tablets of Imatinib Zentiva to take.

The usual starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.

Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.

Use in children

The doctor will tell you how many tablets of Imatinib Zentiva to give to your child. The amount of Imatinib Zentiva 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 Imatinib Zentiva

• Take Imatinib Zentiva with a meal. This will help protect you from stomach problems when taking Imatinib Zentiva.
• Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

• Use about 200 ml for each 400 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass.

How long to take Imatinib Zentiva

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

If you take more Imatinib Zentiva than you should

If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Zentiva

• 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.

Like all medicines, this medicine 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: may affect more than 1 in 10 people.
• Common: may affect up to 1 in 10 people.
• Uncommon: may affect up to 1 in 100 people.
• Rare: may affect up to 1 in 1,000 people.
• Very rare: may affect up to 1 in 10,000 people.
• 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. Imatinib Zentiva may cause your body to retain water (severe fluid retention).

• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Zentiva 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 Raynaud’s 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 and/or 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

• 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. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• 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 Zentiva contains

• The active substance is imatinib mesilate. Each tablet of Imatinib Zentiva contains imatinib mesilate equivalent to 400 mg imatinib.
  • The other ingredients are, microcrystalline cellulose (E460), low substituted hydroxypropyl cellulose (E463), povidone (E1201), crospovidone (Type A) (E1201), silica colloidal anhydrous, magnesium stearate (E572).
  • The tablet coating is made of hypromellose (E464), Macrogol 400, talc (E553b), red iron oxide (E172), yellow iron oxide (E172).

What Imatinib Zentiva looks like and contents of the pack

Imatinib Zentiva 400 mg film-coated tablets are dark yellow to brownish-orange, ovaloid shaped, film- coated tablets, 21.6 mm long & 10.6mm wide (± 5%) wide with a break-line on one side and ‘400’ on the other side. The tablet can be divided into equal doses.

They are supplied in packs containing

10, 20, 30, 60, 90, 120, 180 film-coated tablets. but these may not all be available in your country.

Marketing Authorisation Holder

Zentiva, k.s.

U kabelovny 130, 102 37 Prague 10, Tsjechië

Manufacturer

Remedica Ltd

Limassol Industrial Estate, Aharnon Street

P.O. Box 51706

3508 Limassol

Cyprus-Europa

In het register ingeschreven onder RVG 111115.

<This medicinal product is authorised in the Member States of the EEA under the following names:>

Netherlands	Imatinib Zentiva 100 mg
Bulgaria	Imatinib Zentiva
Cyprus	Imatinib Zentiva
Estonia	Imatinib Zentiva 100mg
Lithuania	Imatinib Zentiva 100 mg plėvele dengtos tabletės
Latvia	Imatinib Zentiva 100 mg apvalkotās tabletes
Poland	Imatinib Zentiva
Romania	Imatinib Zentiva 100 mg comprimate filmate
Slovenia	Imatinib Zentiva 100 mg filmsko obložene tablete
Slovak Republic	Imatinib Zentiva 100 mg

This leaflet was last revised in {MM/YYYY. <To be completed nationally>