100 mg and 400 mg film-coated tablets
imatinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Imatinib Accord is and what it is used for
2. What you need to know before you use Imatinib Accord
3. How to take Imatinib Accord
4. Possible side effects
5. How to store Imatinib Accord
6. Contents of the packaging 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. The drug acts by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.

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

  • Chronic myeloid leukemia (CML). Leukemia is a cancer of the white blood cells . These white blood cells usually help the body fight infection . Chronic myeloid leukemia is a form of leukemia in which certain abnormal white blood cells (so-called myeloid cells) begin to grow out of control.
  • Philadelphia chromosome-positive acute lymphoblastic leukemia ( Ph- positive ALL). Leukemia is a cancer of the white blood cells . These white blood cells normally help the body fight infection . Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal, immature white blood cells (so-called lymphoblasts ) begin to grow out of control. Imatinib Accord inhibits the growth of these cells.

Imatinib Accord is also an adult treatment for:

  • Myelodysplastic / myeloproliferative disorders (MDS / MPD). These are a group of blood diseases in which certain blood cells begin to grow out of control. Imatinib Accord inhibits the growth of these cells in a certain subset of these diseases.
  • Hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukemia (CEL). These are blood diseases in which certain blood cells (so-called eosinophils ) begin to grow out of control. Imatinib Accord inhibits the growth of these cells in a certain subset of these diseases.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Imatinib Accord inhibits the growth of these cells.

In the rest of this leaflet, abbreviations will be used when talking about these diseases.

Ask your doctor if you have any questions about how this medicine works or why this medicine has been prescribed for you.

2. What you need to know before you use Imatinib Accord

Do not use Imatinib Accord

Imatinib Accord will only be prescribed to you by a doctor with medical experience in treating different types of blood cancers or solid tumors.

Follow all of your doctor’s instructions carefully, although these may differ from the general information 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, do not take Imatinib Accord without telling your doctor.

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

Warnings and cautions

Talk to your doctor before taking Imatinib Accord:

  • if you have or have had a liver, kidney or heart disease.
  • if you are taking the medicine levothyroxine due to that your thyroid gland has been removed.
  • if you have ever had or may now have a hepatitis B infection . The reason for this is that Imatinib Accord can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their physician for signs of this infection before starting treatment.
  • if you get bruises, bleeding, fever, get very tired and confused when taking Imatinib Accord, contact your doctor. This may be a sign of an injury to the blood vessels called thrombotic microangiopathy (TMA).

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

You may become more sensitive to the sun while taking Imatinib Accord. It is important to cover exposed areas of the skin and use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.

When taking Imatinib Accord, tell your doctor immediately if you gain weight quickly. Imatinib Accord can cause your body to bind fluid (severe fluid retention ).

When you are taking Imatinib Accord, your doctor will regularly check that the medicine is working. You will also be given blood samples and weighed regularly.

Children and young people

Imatinib Accord is also a treatment for children and adolescents with CML. There is no experience from children and adolescents with CML under 2 years. There is limited experience from children and adolescents with Ph-positive ALL and very limited experience from children and adolescents with MDS / MPD, DFSP, and HES / CEL.

Some children and adolescents taking Imatinib Accord may grow more slowly than usual. Your doctor will regularly check your growth.

Other medicines and Imatinib Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (eg paracetamol ) and herbal medicines (eg St. John’s wort ). Some medicines may affect the effect of Imatinib Accord when taken together. They may increase or decrease the effect of Imatinib Accord and either leads to more side effects or make Imatinib Accord less effective. Imatinib Accord can do the same for some other medicines.

Tell your doctor if you are taking medicines that prevent the formation of blood clots.

Pregnancy, breastfeeding 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 using this medicine.
  • Imatinib Accord is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Accord during pregnancy.
  • Women who may become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
  • Do not breast-feed during treatment with Imatinib Accord and for 15 days after stopping treatment as it may be harmful to your baby.
  • Patients who are concerned about their fertility when taking Imatinib Accord are advised to consult their doctor.

Driving and using machines

You may feel dizzy or tired or have blurred vision when using this medicine. If this happens, do not drive or use any tools or machines until you feel well again.

How to take Imatinib Accord

Your doctor has prescribed Imatinib Accord because you are suffering from a serious illness. Imatinib Accord can help you 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. Ask your doctor or pharmacist if you are unsure.

Do not stop taking Imatinib Accord unless your doctor tells you to. If you can not take the medicine according to your doctor’s prescription or if you feel that you do not need it anymore, contact your doctor immediately.

How much Imatinib Accord to take?

Use for adults

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

– If you are being treated for KML:

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

  • 400 mg taken as 4 tablets of 100 mg and 1 tablet of 400 mg of a once a day,
  • 600 mg taken as 6 tablets of 100 mg and 1 tablet of 400 mg plus 2 tablets of 100 mg, a once a day.

– At KML, 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-positive ALL:

the starting dose is 600 mg taken as 6 tablets of 100 mg and 1 tablet of 400 mg plus 2 tablets of 100 mg, once daily.

– If you are being treated for MDS / MPD:

the starting dose is 400 mg taken as 4 tablets of 100 mg and 1 tablet of 400 mg once daily.

– If you are being treated for HES / CEL:

the starting dose is 100 mg taken as 1 tablet of 100 mg, once daily. Your doctor may decide to increase the dose of one 400 mg to be taken as 4 tablets of 100 mg and 1 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 taken as 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 for children and adolescents

Your doctor will tell you how many Imatinib Accord tablets to give to your child. The amount of Imatinib Accord given depends on your child’s condition, body weight, and height. The total dose one for children and adolescents should not exceed 800 mg for CML and 600 mg for Ph-positive ALL. The treatment can either be given to your child as a single dose or alternatively the daily dose can be given on two different occasions (half in the morning and a half in the evening).

When and how to take Imatinib Accord?

– Take Imatinib Accord with a meal. It helps to protect against stomach problems when you take Imatinib Accord.

– Swallow the capsules whole with a large glass of water.

If you have difficulty swallowing the tablets, you can dissolve them in a glass of non-carbonated water or apple juice.

  • Use about 50 ml for a 100 mg tablet or 200 ml for a 400 mg tablet.
  • Stir with a spoon until the tablet has completely dissolved.
  • When the tablets are completely dissolved, drink the entire contents of the glass at once. Traces of the dissolved tablet may remain in the glass.

How long to take Imatinib Accord?

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

If you take more Imatinib Accord than you should

Contact your doctor immediately if you have accidentally taken too many tablets. 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, skip the missed dose if it is soon time to take the next dose .
  • – Then continue with your normal schedule.
  • – Do not take a double dose to make up for a forgotten dose .

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually of mild to moderate severity.

Some side effects can be serious. Tell your doctor immediately if you get any of the following:

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

  • Rapid weight gain. Imatinib Accord can cause your body to bind water (severe fluid retention ).
  • Signs of infection , e.g. fever, frostbite, sore throat or sore mouth. Imatinib Accord can lead to a reduction in the number of white blood cells so that you can get infection more easily .
  • Sudden bleeding or sores (when you have not injured yourself).

Uncommon (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, difficulty breathing or painful breathing (signs of lung problems).
  • Feeling dizzy, dizzy or fainting (signs of low blood pressure ).
  • Nausea, with decreased appetite, dark-colored urine, yellowing of the skin or eyes (signs of liver problems).
  • Skin rash, redness with blisters on lips, eyes, skin or mouth, flaking of the skin, fever, raised red or purple skin areas, itching , burning sensation, rash with small blisters (signs of skin problems).
  • Severe abdominal pain, blood in vomit, stool or urine, black stools (signs of gastrointestinal disease).
  • Severe decreased urine output, thirst (signs of kidney problems).
  • Nausea, with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems).
  • Severe headache, weakness or paralysis of the legs or face, difficulty speaking, sudden unconsciousness (signs of nervous system problems such as bleeding or swelling of the skull / brain).
  • Paleness, fatigue and shortness of breath with dark urine (signs of low level of red blood cells ).
  • Eye pain or impaired vision, bleeding in the eyes.
  • Pain in the 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 cellulite ).
  • Hearing loss.
  • Muscle weakness and muscle cramps with abnormal heart rhythm (signs that indicate changes in the amount of potassium in your blood).
  • Tendency to get bruises.
  • Stomach pain, with nausea.
  • Muscle cramps, with 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, dizziness or fainting due to low blood pressure (signs of ovarian or uterine problems).
  • Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and / or joint problems associated with abnormal laboratory values ​​(eg high potassium , uric acid and calcium levels, as well as low phosphorus levels in the blood).
  • Blood clots in small blood vessels (thrombotic microangiopathy).

Has been reported (occurs in an unknown number of users):

  • Combination of severe skin rash, nausea, fever, high levels of certain white blood cells or yellow skin or eyes (signs of jaundice) with shortness of breath, chest pain / discomfort, greatly reduced urine production and feeling of thirst, etc. (signs of treatment- related allergic reaction ).
  • Chronic renal failure
  • Recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).

Tell your doctor immediately if you get any of the above.

Other side effects may include:

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

  • Headache or fatigue.
  • Nausea, vomiting, diarrhea or indigestion.
  • Rash.
  • Muscle cramps or pain in joints, muscles or bones during treatment with Imatinib Accord or after stopping Imatinib Accord.
  • Swelling around joints or swollen eyes.
  • Weight gain.

Tell your doctor if any of these affect you seriously.

Common (may affect up to 1 in 10 people):

  • Decreased appetite, weight loss or taste disorders.
  • Dizziness or weakness.
  • Sleep problems ( insomnia ).
  • Runny eyes with itching , redness and swelling (conjunctivitis), watery eyes or blurred vision.
  • Nosebleed.
  • Abdominal pain or distended abdomen, flatulence, heartburn, constipation.
  • Itching .
  • Unexpectedly heavy hair loss or thinning of the hair.
  • Numbness in hands and feet.
  • Sores in the mouth.
  • Joint pain with swelling.
  • Dry mouth , dry skin or dry eyes.
  • Decreased or increased sensitivity of the skin.
  • Hot flashes, chills or night sweats.

Tell your doctor if any of these affect you seriously.

Has been reported (occurs in an unknown number of users):

  • Redness and / or swelling in the palms and soles of the feet which may be accompanied by a stinging sensation or burning pain.
  • Painful changes in the skin with or without blisters.
  • Slow growth in children and adolescents.

Tell your doctor if any of these affect you seriously.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Imatinib Accord

  • 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 expiration date is the last day of the specified month.
  • For PVC / PVdC / aluminum blisters Store below
    30 ° C.
  • For aluminum / aluminum blisters
    No special precautions for storage.
  • Do not use if any packaging is damaged or shows signs of having been opened or otherwise handled improperly.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is imatinib mesylate. Each 100 mg film-coated tablet Imatinib Accord contains 100 mg imatinib (as mesylate).Each 400 mg film-coated tablet Imatinib Accord contains 400 mg imatinib (as mesylate).
  • The other ingredients are microcrystalline cellulose, crospovidone, hypermellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica. The film coating is made of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide, yellow (E172) and iron oxide, red (E172).

What the medicine looks like and contents of the pack

Imatinib Accord 100 mg film-coated tablets are brown-orange, round, biconvex, film-coated tablets, marked “IM” and “T1” on one side of the breaker, and unlabeled on the other side.

Imatinib Accord 400 mg film-coated tablets are brown-orange, oval, biconvex, film-coated tablets marked “IM” and “T2” on one side of the breaker, and unlabeled on the other side.

Imatinib Accord 100 mg film-coated tablets are supplied in packs of 20, 60, 120, or 180 tablets, but not all pack sizes may be marketed.

Imatinib Accord 100 mg tablets are also available in perforated single-dose blisters of PVC / PVdC / aluminum in pack sizes of 30×1, 60×1, 90×1, 120×1 and 180×1 film-coated tablets.

Imatinib Accord 400 mg film-coated tablets are supplied in packs of 10, 30, or 90 tablets, but not all pack sizes may be marketed.

Imatinib Accord 400 mg tablets are also available in perforated single-dose blisters of PVC / PVdC / aluminum in pack sizes containing 30×1, 60×1 and 90×1 film-coated tablets.

Marketing Authorisation Holder

Accord Healthcare SLU

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

UK

or

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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