Imatinib Accord 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Imatinib Accord 100 mg film-coated tablets EFG

Imatinib Accord 400 mg film-coated tablets EFG

imatinib

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

• Keep this leaflet. You may need to read it again.

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

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Imatinib Accord is and what it is used for
2. What you need to know before taking Imatinib Accord
3. How to take Imatinib Accord
4. Possible side effects
5. How to store Imatinib Accord
6. Contents of the pack and other information

1. What Imatinib Accord is and what it is used for

Imatinib Accord is a medicine that contains an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases described below. These include certain types of cancer.

Imatinib Accord is a treatment for adults, and children and adolescents for:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body fight infections. Chronic myeloid leukaemia is a type of leukaemia in which abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.

• Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells.

Imatinib Accord is also a treatment for adults for:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood disorders in which certain blood cells begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells in a specific subtype of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells in a specific subtype of these diseases.
• Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and intestine. It arises from uncontrolled cell growth in the supportive tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which certain cells begin to grow uncontrollably. Imatinib Accord inhibits the growth of these cells.

In the remainder of this leaflet, these abbreviations are used when referring to these diseases.

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

2. What you need to know before starting to take Imatinib Accord

Imatinib Accord will only be prescribed by a doctor experienced in the use of medicines for treating blood cell cancers or solid tumours.

Carefully follow all instructions from your doctor, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Accord

• if you are allergic to imatinib or to any of the other ingredients of this medicine (listed in section 6).

If this applies to you, inform your doctor and do not take Imatinib Accord.

If you think you may be allergic but are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take Imatinib Accord:

• if you have or have had any liver, kidney, or heart problems.

• if you are taking a medicine containing levothyroxine because your thyroid gland has been removed.

  • if you have ever had, or could currently have, an infection with the hepatitis B virus. This is because Imatinib Accord could cause hepatitis B to become active again, which may be fatal in some cases. Your doctor will need to carefully check for signs of this infection before starting treatment.

• if you develop bruising, bleeding, fever, fatigue, or confusion while taking Imatinib Accord, please contact your doctor immediately. These could be signs of blood vessel damage called thrombotic microangiopathy (TMA).

If any of these apply to you, inform your doctor before taking Imatinib Accord.

You may become more sensitive to sunlight while taking Imatinib Accord. It is important to cover skin areas exposed to sunlight and to use high-protection sunscreen. These precautions also apply to children.

During treatment with Imatinib Accord, inform your doctor immediately if you gain weight rapidly. Imatinib Accord may cause fluid retention in the body (severe fluid retention).

While taking Imatinib Accord, your doctor will regularly monitor whether the medicine is working. You will also have regular blood tests and be weighed regularly.

Children and adolescents

Imatinib Accord is also a treatment for children and adolescents with CML. There is no experience with children and adolescents under 2 years of age with CML. Experience in children and adolescents with Ph-positive ALL is limited, and experience in children and adolescents with MDS/MPN, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents taking Imatinib Accord may have slower than normal growth. Your doctor will monitor growth during periodic visits.

Interaction of Imatinib Accord with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription (such as paracetamol) and even herbal medicines (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Accord when taken together. These may increase or decrease the effect of Imatinib Accord, leading to an increase in side effects or making Imatinib Accord less effective. Imatinib Accord may also affect other medicines in the same way.

Inform your doctor if you are taking medicines that prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

  • Use of Imatinib Accord during pregnancy is not recommended unless clearly necessary, as it may harm your baby. Your doctor will discuss with you the potential risks of taking Imatinib Accord during pregnancy.
  • Women who could become pregnant are advised to use an effective method of contraception during treatment and for 15 days after stopping treatment.

• Do not breastfeed during treatment with Imatinib Accord and for the following 15 days after stopping treatment, as it may harm your baby.

• Patients concerned about fertility while taking Imatinib Accord should discuss this with their doctor.

Driving and using machines

You may experience dizziness, drowsiness, or blurred vision while taking this medicine. If you experience these symptoms, do not drive or operate tools or machinery until you feel well again.

3. How to take Imatinib Accord

Your doctor has prescribed Imatinib Accord because you suffer from a serious illness. Imatinib Accord can help you fight this disease.

However, follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. It is important that you do so for the length of time prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not stop taking Imatinib Accord unless instructed by your doctor. If you are unable to take the medicine as prescribed or think you no longer need to take it, contact your doctor immediately.

How much to take of Imatinib Accord

Use in adults

Your doctor will tell you exactly how many Imatinib Accord tablets you should take.

• If you are being treated for CML

Depending on your condition, the normal starting dose is 400 mg or 600 mg:

• 400 mg, i.e. 4 tablets of 100 mg or 1 tablet of 400 mg once daily,

• 600 mg, i.e. 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once daily.

• If you are being treated for GIST:

The starting dose is 400 mg, taken once daily.

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 tablets of 100 mg or 2 tablets of 400 mg), you should take 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.

• If you are being treated for Ph+ ALL

The starting dose is 600 mg, i.e. 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once daily.

• If you are being treated for MDS/MPN

The starting dose is 400 mg, i.e. 4 tablets of 100 mg or 1 tablet of 400 mg once daily.

• If you are being treated for HES/CEL

The starting dose is 100 mg, i.e. one tablet of 100 mg once daily. Your doctor may decide to increase the dose to 400 mg, i.e. 4 tablets of 100 mg or one tablet of 400 mg once daily, depending on how you respond to treatment.

• If you are being treated for DFSP

The dose is 800 mg per day, i.e. 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.

Use in children and adolescents

Your doctor will tell you how many Imatinib Accord tablets to give to the child. The amount of Imatinib Accord given will depend on the child's condition, body weight, and height. The total daily dose in children and adolescents must not exceed 800 mg in CML and 600 mg in Ph+ ALL. The treatment may be given to the child once daily or, alternatively, the dose may be divided into two doses (half in the morning and half in the evening).

When and how to take Imatinib Accord

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

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

• Use about 50 mL for each 100 mg tablet or 200 mL for each 400 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.
• Once the tablet has dissolved, drink the entire glass immediately. There may be residue from the dissolved tablets remaining in the glass.

How long to take Imatinib Accord

Continue taking Imatinib Accord every day for as long as your doctor tells you.

If you take more Imatinib Accord than you should

If you have accidentally taken too many tablets, speak with your doctor immediately. You may require medical attention. Bring the medicine packaging with you.

If you forget to take Imatinib Accord

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Then continue with your regular dosing schedule.
• Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These are usually mild to moderate.

Some adverse effects may be serious. Inform your doctor immediately if you experience any of the following

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

• Rapid weight gain. Imatinib Accord may cause your body to retain fluid (severe fluid retention).

• Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib Accord may reduce the number of white blood cells, making you more susceptible to infections.

• Bleeding or bruising unexpectedly (when you have not sustained an injury).

Uncommon adverse effects (may affect up to 1 in 100 people) or rare adverse effects (may affect up to 1 in 1,000 people)

• Chest pain, irregular heartbeat (signs of heart problems).

• Cough, with difficulty breathing or painful breathing (signs of lung problems).

• Dizziness, lightheadedness, or fainting (signs of low blood pressure).

• Nausea, with loss of appetite, dark-coloured urine, yellowing of the skin or eyes (signs of liver problems).

• Skin rash, redness, blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).

• Severe abdominal pain, blood in vomit, stools, or urine, black stools (signs of gastrointestinal disturbances).

• Marked decrease in urine output, feeling of thirst (signs of kidney problems).

• Nausea, with diarrhoea and vomiting, abdominal pain, or fever (signs of intestinal problems).

• Severe headache, weakness or paralysis in limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).

• Pale skin, feeling tired and shortness of breath, dark-coloured urine (signs of low red blood cell count).

• Eye pain or vision disturbances.

• Hip pain or difficulty walking.

• Numbness or cold sensation in feet and fingers (signs of Raynaud's syndrome).

• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).

• Hearing difficulties.

• Muscle weakness and muscle spasms, with an abnormal heartbeat (signs of changes in blood potassium levels).

• Bruising.

• Stomach pain with nausea.

• Muscle cramps with fever, red-brownish urine, muscle pain or weakness (signs of muscle problems).

• Pelvic pain, sometimes with nausea and vomiting, unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems in ovaries or uterus).

• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. elevated levels of potassium, uric acid and calcium, and low levels of phosphorus in the blood).

• Blood clots in small blood vessels (thrombotic microangiopathy).

Frequency not known (cannot be estimated from available data)

• Combination of widespread rash, feeling unwell, fever, elevated levels of certain blood cells or yellowing of the skin or eyes (signs of jaundice) with difficulty breathing, chest pain/discomfort, severely reduced urine output, and feeling thirsty, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure
• Reactivation of hepatitis B virus infection if you have previously had hepatitis B (a liver infection)

If you experience any of the above, inform your doctor immediately.

Other adverse effects may include

Very common adverse effects (may affect more than 1 in 10 people)

• Headache or feeling tired
• Nausea, vomiting, diarrhoea, or indigestion.
• Rash.
• Muscle cramps or pain in joints, muscles, or bones during treatment with Imatinib Accord or when stopping treatment.
• Swelling such as puffy ankles or eyes.
• Weight gain.

If any of these affect you significantly, inform your doctor.

Common adverse effects (may affect up to 1 in 10 people)

• Loss of appetite, weight loss, or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Watery, itchy, red, and swollen eyes (conjunctivitis), watery eyes, or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Unusual hair thinning or hair loss.
• Numbness in hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flushes, chills, or night sweats.

If any of these affect you significantly, consult your doctor.

Frequency not known (cannot be estimated from available data)

• Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and burning pain.
• Painful and/or blistering skin lesions.
• Delayed growth in children and adolescents.

If any of these affect you significantly, consult your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imatinib Accord

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.

• For PVC/PVdC/aluminum blisters:

Do not store above 30°C.

• For aluminum/aluminum blisters:

This medicine does not require any special storage conditions.

• Do not use any packaging if it appears damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Imatinib Accord

• The active substance is imatinib mesilate.

Each 100 mg film-coated tablet of Imatinib Accord contains 100 mg of imatinib (as mesilate).

Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg of imatinib (as mesilate).

• The other components are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and colloidal anhydrous silica. The tablet coating consists of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, yellow iron oxide (E172) and red iron oxide (E172).

What Imatinib Accord looks like and contents of the pack

Imatinib Accord 100 mg film-coated tablets are orange-brown, round, biconvex, marked on one side with "IM" and "T1" on either side of the breakline, and smooth on the other side.

Imatinib Accord 400 mg film-coated tablets are orange-brown, oval-shaped, biconvex, marked on one side with "IM" and "T2" on either side of the breakline, and smooth on the other side.

Imatinib Accord 100 mg film-coated tablets are available in packs containing 20, 60, 120 or 180 tablets, although not all pack sizes may be available in your country.

Additionally, Imatinib Accord 100 mg tablets are also available in perforated PVC/PVdC/aluminium unit dose blisters in packs of 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.

Imatinib Accord 400 mg film-coated tablets are available in packs containing 10, 30 or 90 tablets, although not all pack sizes may be available in your country.

Additionally, Imatinib Accord 400 mg tablets are available in perforated PVC/PVdC/aluminium unit dose blisters in packs of 30x1, 60x1, 90x1 film-coated tablets.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6th floor,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of the most recent revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu