Tibaldix 400 mg filmomhulde tabletten

TIBALDIX 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.

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 TIBALDIX 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.

TIBALDIX 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. Imatinib 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. Imatinib 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. Imatinib 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. Imatinib 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 TIBALDIX works or why this medicine has been prescribed for you, ask your doctor.

Imatinib which is contained in TIBALDIX is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

TIBALDIX 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 TIBALDIX

• 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 TIBALDIX

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 TIBALDIX:

• 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 TIBALDIX.

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

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

Children and adolescents

TIBALDIX 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 and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

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

Other medicines and TIBALDIX

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 TIBALDIX when taken together. They may increase or decrease the effect of TIBALDIX, either leading to increased side effects or making TIBALDIX less effective. TIBALDIX 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.
• TIBALDIX 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 TIBALDIX during pregnancy.
• Women who might become pregnant are advised to use effective contraception during treatment.
• Do not breast-feed during the treatment with TIBALDIX.
• Patients who are concerned about their fertility while taking TIBALDIX 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 TIBALDIX because you suffer from a serious condition. TIBALDIX can help you to fight this condition.

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.

Do not stop taking TIBALDIX 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 TIBALDIX to take

Use in adults

Your doctor will tell you exactly how many tablets of TIBALDIX to take.

• If you are being treated for CML: Depending on your condition the usual starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.



• If you are being treated for GIST:

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

For CML and GIST 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.

• If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.

• If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as one tablet once a day.
• If you are being treated for HES/CEL: The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet 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 tablets), to be taken as 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 TIBALDIX to give to your child. The amount of TIBALDIX 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 TIBALDIX

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

The tablet can be divided into equal doses.

How long to take TIBALDIX

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

If you take more TIBALDIX 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 TIBALDIX

• 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.

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. TIBALDIX may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. TIBALDIX 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 (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.

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.

What TIBALDIX contains

• The active substance is imatinib mesilate. Each tablet of TIBALDIX 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 TIBALDIX looks like and contents of the pack

TIBALDIX 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.

They are supplied in packs containing 30 film-coated tablets

Marketing Authorisation Holder

PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c

170 00 Praha 7

Czech Republic

Manufacturer

Remedica Ltd., Limassol, Cyprus

PharmaSwiss d.o.o., Ljubljana, Slovenia

In het register ingeschreven onder: RVG 111111

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

Netherlands:	TIBALDIX 100 mg Filmomhulde tabletten
Czech Republic:	TIBALDIX 100 mg
Estonia:	TIBALDIX
Hungary:	TIBALDIX 100 mg Filmtabletta
Lithuania:	TIBALDIX 100 mg plėvele dengtos tabletės

Latvia:	TIBALDIX 100 mg apvalkotās tabletes
Poland:	TIBALDIX
Slovak Republic:	TIBALDIX 100 mg

This leaflet was last revised in July 2013