Package leaflet: Information for the patient

Nibix, 400 mg, capsule, hard

Imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. Y ou may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Nibix is and what it is used for

2.    What you need to know before you take Nibix

3.    How to take Nibix

4.    Possible side effects

5.    How to store Nibix

6.    Contents of the pack and other information

1. What Nibix is and what it is used for

Nibix 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.

Nibix 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.

In adult patients, Nibix is used to treat a late stage of chronic myeloid leukaemia called “blast crisis”. In children and adolescents it may be used to treat all stages of the illness.

-    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. Nibix inhibits the growth of these cells.

Nibix is also a treatment for adults for:

-    Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Nibix 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. Nibix inhibits the growth of these cells in a certain subtype of these diseases.

- Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Nibix 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 Nibix works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Nibix

Nibix 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 Nibix:

-    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 Nibix.

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

Warning and precautions

Talk to your doctor before taking Nibix:

-    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 Nibix.

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

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

Children and adolescents

Nibix 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 with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.

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

Other medicines and Nibix

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

Pregnancy

Nibix 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 Nibix during pregnancy.

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

Breast-feeding

Do not breast-feed during the treatment with Nibix.

Fertility

Patients who are concerned about their fertility while taking Nibix 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.

Nibix 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 medicinal product.

3. How to take Nibix

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

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

Do not stop taking Nibix 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 Nibix to take

Use in adults

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

- If you are being treated for CML:

The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100mg capsules 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 capsules), you should take one capsule in the morning and a second capsule in the evening.

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

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

-    If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as one capsule once a day.

-    If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as one 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 (2 capsules), to be taken as one capsule in the morning and one capsule in the evening.

Use in children and adolescents

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

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

-    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 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 Nibix

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

If you take more Nibix 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 Nibix

-    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 or 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.

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. Nibix may cause your body to retain water (severe fluid retention).

-    Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Nibix 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, 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.

-    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 cellulitis).

-    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 (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:

-    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.

5. How to store Nibix

-    Store below 30°C.

-    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 and blister after EXP. The expiry date refers to the last day of the month.

-    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 information What Nibix contains

-    The active substance is imatinibe mesilate. Each capsule of Nibix contains 400 mg of imatinib (as mesilate).

-    The other ingredients are crospovidone (type A), lactose monohydrate and magnesium stearate

-    The capsule shell is made of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).

What Nibix looks like and contents of the pack

Nibix, 400 mg, hard capsule are gelatin capsules of size “00” with caramel body and cap. They are supplied in packs containing 10, 30, 90 or 100 capsules, but these may not all be available in your country.

Marketing Authorisation Holder Zaklad Farmaceutyczny Adamed Pharma S.A. Pienkow 149, 05-124 Czosnow Poland

Manufacturer

Pabianickie Zaklady Farmaceutyczne Polfa S.A. ul. Marsz. J. Pilsudskiego 5 95-200 Pabianice Poland

UAB Norameda

Meistr^ 8a, Vilnius LT-02189

Lithuania

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

Nibix 400 mg TBtpga kancyna Marimab 400 mg kietosios kapsules Nibix

Nibix, 400 mg capsule Nibix 400 mg trde kapsule Nibix 400 mg capsule, hard

This leaflet was last revised in 10.2013