IMATINIB ACCORD 400 mg FILM-COATED TABLETS

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 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Imatinib Accord is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases described below. These include some 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 to fight infections. Chronic myeloid leukaemia is a type of leukaemia in which some abnormal white blood cells (called myeloid cells) start to grow out of control.

• 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 to fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which some abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatinib Accord inhibits the growth of these cells.

Imatinib Accord is also a treatment for adults for:

• Mycloproliferative/neoplastic diseases (MPD/MNP). These are a group of blood diseases in which some blood cells start to grow out of control. Imatinib Accord 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 (called eosinophils) start to grow out of control. Imatinib Accord inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal stromal tumours (GISTs). GIST is a cancer of the stomach and intestine. It originates from uncontrolled cell growth of the supporting tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which some cells start to grow out of control. Imatinib Accord inhibits the growth of these cells.

In the rest 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 you take Imatinib Accord

Imatinib Accord will only be prescribed by a doctor with experience in medicines for treating blood cell cancer or solid tumours.

Follow carefully all instructions given by 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 any of the other ingredients of this medicine (listed in section 6).

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

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

Warnings and precautions

Talk to your doctor before starting to take Imatinib Accord:

• if you have or have had liver, kidney, or heart problems.
• if you are taking a medicine that contains levothyroxine because you have had your thyroid gland removed.
• if you have ever had or might currently have a hepatitis B virus infection. This is because Imatinib Accord could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor should check carefully for signs of this infection before starting treatment.

• if while taking Imatinib Accord you get bruises, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of blood vessel damage called thrombotic microangiopathy (TMA).

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

You may be more sensitive to the sun while taking Imatinib Accord. It is important that you cover the areas of your skin that are exposed to the sun and use a high-protection sunscreen. These precautions also apply to children.

During treatment with Imatinib Accord, tell your doctor immediatelyif you gain weight very quickly. Imatinib Accord can cause water retention in the body (severe fluid retention).

While taking Imatinib Accord, your doctor will regularly check if 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 in children and adolescents with CML under 2 years of age. The experience in children and adolescents with Ph+ ALL is limited, and the experience in children and adolescents with MPD/MNP, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents who take Imatinib Accord may have slower than normal growth. The doctor will check growth during regular visits.

Interaction of Imatinib Accord with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may interfere with the effect of Imatinib Accord when taken together. They may increase or decrease the effect of Imatinib Accord, leading to an increased risk of side effects or making Imatinib Accord less effective. Imatinib Accord may have the same effect on other medicines.

Tell your doctor if you are taking medicines that prevent blood clots from forming.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Imatinib Accord is not recommended during pregnancy 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 up to 15 days after finishing treatment.

• Do not breastfeed while taking Imatinib Accord and for 15 days after finishing treatment, as it may harm your baby.
• Patients who are concerned about their fertility while taking Imatinib Accord should consult their doctor.

Driving and using machines

You may feel dizzy or drowsy or have blurred vision while taking this medicine. If you do, do not drive or use tools or machines until you feel better.

3. How to take Imatinib Accord

Your doctor has prescribed Imatinib Accord for you because you have a serious illness. Imatinib Accord can help you fight this illness.

However, follow exactly the instructions for taking this medicine given by your doctor or pharmacist. It is important that you do this for the time your doctor or pharmacist tells you. If you are in doubt, consult your doctor or pharmacist again.

Do not stop taking Imatinib Accord unless your doctor tells you to. If you cannot take the medicine as your doctor has prescribed or think you no longer need 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 to take.

• If you are being treated for CML

Depending on your situation, the usual starting dose is 400 mg or 600 mg:

• 400 mg, i.e., 4 tablets of 100 mg or 1 tablet of 400 mg once a day,
• 600 mg, i.e., 6 tablets of 100 mg or 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, taken once a day.

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 oncea day.

• If you are being treated for MPD/MNP

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

• If you are being treated for HES/CEL

The starting dose is 100 mg, i.e., 1 tablet of 100 mg oncea day. Your doctor may decide to increase the dose to 400 mg, i.e., 4 tablets of 100 mg or 1 tablet of 400 mg oncea day, depending on how you respond to treatment.

• If you are being treated for DFSP

The dose is 800 mg a 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 situation, body weight, and height. The total daily dose in children and adolescents should not exceed 800 mg in CML and 600 mg in Ph+ ALL. The treatment can be given to the child once a day or, alternatively, the dose can 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 can 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 have completely dissolved.
• Drink the whole glass immediately. There may be remaining parts of the dissolved tablets in the glass.

How long to take Imatinib Accord

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

If you take more Imatinib Accord than you should

If you accidentally take too many tablets, talk to your doctor immediately. You may need medical attention. Take the medicine pack 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 the next dose, do not take the missed dose.
• Then continue with the normal schedule.
• Do not take a double dose to make up for missed doses.

If you have any other 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 all people suffer from them. These are usually mild to moderate.

Some adverse effects can be serious. Inform your doctor immediately if you suffer from any of the following

Very Common Adverse Effects(may affect more than 1 in 10 people) or Common(may affect up to 1 in 10 people)

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

• Signs of infection such as fever, severe chills, sore throat, or ulcers in the mouth. Imatinib Accord may reduce the number of white blood cells in your blood, so you may suffer from infections more easily.

• Bleeding or bruising unexpectedly (when you have not suffered any injury).

Uncommon Adverse Effects(may affect up to 1 in 100 people) or Rare(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).
• Feeling of dizziness, dizziness, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, yellowish skin or eyes (signs of liver problems).

• Rash, skin redness, with blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin spots, itching, burning sensation, rash with pustules (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in urine output, feeling of thirst (signs of kidney problems).
• Nausea, with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in the limbs or face, difficulty speaking, sudden loss of consciousness (signs of problems in the nervous system, such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of fatigue, and difficulty breathing, dark-colored urine (signs of a low level of red blood cells in the blood).
• Pain in the eyes or vision disorders.
• Pain in the hip or difficulty walking.
• Numbness or feeling of cold in the feet and toes (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 the amount of potassium in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, reddish-brown urine, pain, or weakness in the muscles (signs of muscle problems).
• Pain in the pelvis, sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling of dizziness or fainting due to low blood pressure (signs of problems in the ovaries or uterus).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal laboratory test results (e.g., high 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 the available data)

• Combination of a widespread rash, feeling of discomfort, fever, high levels of certain blood cells, or yellowish skin and eyes with difficulty breathing, chest pain, greatly reduced urine production, and feeling of thirst, etc. (signs of a treatment-related allergic reaction).
• Chronic kidney failure
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection)

If you suffer from any of the above alterations, inform your doctor immediately.

Other Adverse Effects May Include

Very Common Adverse Effects(may affect more than 1 in 10 people)

• Headache or feeling of fatigue
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the joints, muscles, or bones during treatment with Imatinib Accord or when stopping treatment.
• Swelling such as swollen 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)

• Anorexia, weight loss, or altered sense of taste.
• Feeling of fatigue or weakness.
• Difficulty sleeping (insomnia).
• Tearing of the eyes with itching, redness, and swelling (conjunctivitis), watery eyes, or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, flatulence, heartburn, or constipation.
• Itching.
• Weakness or unusual hair loss.
• Numbness of the hands or feet.
• Ulcers in the mouth.
• Pain in the joints with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

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

Frequency Not Known(cannot be estimated from the available data)

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

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the box and the blister pack after "CAD" or “EXP”. The expiration date refers to the last day of that month.

• For PVC/PVdC/aluminum blister packs

Do not store above 30°C.

• For aluminum/aluminum blister packs

This medicine does not require any special storage conditions.

• Do not use any packaging if you notice that it is damaged or shows signs of tampering.
• Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Accord

• The active ingredient is imatinib mesylate.

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

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

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

Appearance of the Product and Package Contents

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

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

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

Additionally, Imatinib Accord 100 mg tablets are also available in perforated monodose PVC/PVdC/aluminum blister packs in packages of 30x1, 60x1, 90x1, 120x1, or 180x1 film-coated tablets.

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

Additionally, Imatinib Accord 400 mg tablets are available in perforated monodose PVC/PVdC/aluminum blister packs in packages of 30x1, 60x1, 90x1 film-coated tablets.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

Edifici Est 6ª planta,

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 Last Revision of this Prospectus:

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