Imatinib Diamedia 400 mg, filmomhulde tabletten

1. What is and what it is used for

Imatinib belongs to a group of medicines known as protein kinase inhibitors. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib is a treatment for adults and children for:

 Chronic myeloid leukaemia (CML). In adults it is used to treat a certain subtype of this disease called “blast crisis”. In children and adolescents, however, it may be used to treat all stages of the illness. 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.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

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In the rest of this leaflet, we will use the abbreviation CML when talking about this disease.

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

2. What you need to know before you take

Imatinib 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>

 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.

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:

• 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.

During treatment with imatinib, tell your doctor straight away if you put on weight very quickly. Imatinib may cause your body to retain water (severe fluid retention)(see section 4).

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

Children and adolescents

Imatinib 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 may have slower than normal growth. The doctor will monitor the growth at regular visits.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

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Other medicines and <Imatinib>

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 when taken together. They may increase or decrease the effect of imatinib, either leading to increased side effects or making imatinib less effective. Imatinib 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 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 during pregnancy.

Women who might become pregnant are advised to use effective contraception during treatment.

Do not breast-feed during the treatment with imatinib.

Patients who are concerned about their fertility while taking imatinib 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.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

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3. How to take

Your doctor has prescribed imatinib because you suffer from a serious condition. Imatinib 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.

How much <Imatinib> to take Use in adults

Your doctor will tell you exactly how many tablets of imatinib to take. The usual starting dose is 600 mg:

• 600 mg to be taken as 6 tablets once a day.
• 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 (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

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 and adolescents

The doctor will tell you how many tablets of imatinib to give to your child. The amount of imatinib 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>

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

Swallow the tablets whole with a large glass of water.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

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

• Use about 50 ml for each 100 mg tablet.
• 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. <100 mg> The tablet can be divided into equal doses.

How long to take <Imatinib>

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

If you take more <Imatinib> 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>

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 for a forgotten dose.

If you stop taking <Imatinib>

Do not stop taking imatinib 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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 side effects (may affect more than 1 in 10 people) or common side effects (may affect up to 1 in 10 people)

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

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• Rapid weight gain. Imatinib may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib 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 side effects (may affect up to 1 in 100 people) or rare side effects (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, 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).

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

Module 1 - Section 3.1 Core SmPC,
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• 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 (e.g. 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 (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

• Swelling such as round your ankles or puffy eyes • Weight gain

Common side effects (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

Not known side effects (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

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.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

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5. How to store

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’. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

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 contains

• • The active substance is imatinib. Each tablet contains 100 mg imatinib (as mesylate).
  • The active substance is imatinib. Each tablet contains 400 mg imatinib (as mesylate).
  • The other ingredients are:

Tablet core: silica colloidal anhydrous, cellulose microcrystalline (E460), crospovidone, hypromellose (E464) and magnesium stearate (E572).

Tablet coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172), iron oxide red (E172) and titanium dioxide (E171).

What <Imatinib> looks like and contents of the pack

Imatinib 100 mg film-coated tablets are brown, round (9 mm), biconvex, scored on one side and debossed on the other side with ‘I9AB 100’.

Imatinib 400 mg film-coated tablets are brown, oblong (10 x 18 mm), biconvex and debossed on one side with ‘I9AB 400’.

Imatinib 100 mg film-coated tablets are available in blister packs of 20, 60, 120, or 180 film-coated tablets.

Imatinib 400 mg film-coated tablets are available in blister packs of 10, 30, or 90 film-coated tablets.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE

Common Technical Document Imatinib (as mesylate) film-coated tablets

Module 1 - Section 3.1 Core SmPC,
Labelling and Package Leaflet	page 9/9

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Diamedia Kft./Ltd.

H-1023 Budapest, Árpád fejedelem útja 44., III/6

Hongarije

Manufacturer(s):

Synthon BV

Microweg 22

6545CM Nijmegen

Nederland

Synthon Hispania S.L. Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat Spanje

Cemelog-BRS Kft./Ltd.

H-2040 Budaörs, Vasút u. 13.

Hongarije

In het Register ingeschreven onder:

Imatinib Diamedia 100 mg, filmomhulde tabletten: RVG 111178

Imatinib Diamedia 400 mg, filmomhulde tabletten: RVG 111180

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

<{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>

<…>

This leaflet was last revised in juli 2013.

issue date: 01-03-13

version: M1.3.1_03.IAB.mes.tab.001.07.core approved: HEGE