100 mg, 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 can harm them, even if they show signs of illness 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 you will find information about:
1. What Imatinib Fresenius Kabi is and what it is used for
2. What you need to know before taking Imatinib Fresenius Kabi
3. How to take Imatinib Fresenius Kabi
4. Possible side effects
5. How Imatinib Fresenius Kabi to be stored
6. Contents of the packaging and other information

What Imatinib Fresenius Kabi is and what it is used for

Imatinib Fresenius Kabi 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 Fresenius Kabi is a treatment for adults and children 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 inhibits the growth of these cells.

Imatinib Fresenius Kabi is also a treatment for adults 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 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 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 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.

Imatinib contained in Imatinib Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Imatinib Fresenius Kabi

Do not take Imatinib Fresenius Kabi:

Imatinib Fresenius Kabi 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.

  • 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 Fresenius Kabi 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, pharmacist, or nurse before taking Imatinib Fresenius Kabi:

  • 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 Fresenius Kabi 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 Fresenius Kabi, 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 Fresenius Kabi.

You may become more sensitive to the sun while taking Imatinib Fresenius Kabi. 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 Fresenius Kabi, tell your doctor immediately if you gain weight quickly. Imatinib Fresenius Kabi can cause your body to bind fluid (severe fluid retention ).

When you take Imatinib Fresenius Kabi, your doctor will regularly check that the medicine is working. You will be given blood samples and weighed regularly.

Children and young people

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

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

Other medicines and Imatinib Fresenius Kabi

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 Fresenius Kabi when taken together. They may increase or decrease the effect of Imatinib Fresenius Kabi and either leads to more side effects or make Imatinib Fresenius Kabi less effective. Imatinib Fresenius Kabi 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 Fresenius Kabi is not recommended during pregnancy unless it is necessary as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Fresenius Kabi 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 Fresenius Kabi 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 Fresenius Kabi 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.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Imatinib Fresenius Kabi

Your doctor has prescribed Imatinib Fresenius Kabi for you to suffer from a serious illness. Imatinib Fresenius Kabi 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 Fresenius Kabi 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 Fresenius Kabi to take?

Use for adults

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

  • If you are being treated for CML:
    Depending on your condition, the usual starting dose is either 400 mg or 600 mg:
    • 400 mg given as a 400 mg tablet a once a day, or as four 100 mg tablets a once a day.
    • 600 mg given as a 400 mg tablet and two 100 mg tablets on a daily or as six 100 mg tablets a once a day.

For CML, 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), you should take 4 tablets in the morning and 4 tablets in the evening.

  • If you are being treated for Ph- positive ALL:starting dose is 600 mg taken as a 400 mg tablet and two 100 mg tablets a once daily or six 100 mg tablets a once daily.
  • If you are being treated for MDS / MPD
    , the starting dose of 400 mg taken as one 400 mg tablet one time daily, or four 100 mg tablets are a once-daily.
  • If you are being treated for HES / CEL
    , the starting dose is 100 mg, taken as one tablet of 100 mg, a daily dose. Your doctor may decide to increase the dose of one 400 mg taken as one 400 mg tablet one time daily, or four 100 mg tablets are a once daily. Depending on how you respond to treatment.
  • If you are being treated for DFSP:
    the dose of 800 mg per day (two 400 mg tablets or eight 100mg tablets are a once daily) administered as one 400 mg tablet or four 100 mg tablets in the morning and 400 mg tablets or four 100 mg tablets in the evening.

Use for children and adolescents

Your doctor will tell you how many Imatinib Fresenius Kabi tablets to give to your child. The amount of Imatinib Fresenius Kabi given depends on your baby’s condition, body weight, and height. The total dose for children 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 Fresenius Kabi?

  • Take Imatinib Fresenius Kabi with a meal. It helps to protect against stomach problems when you take Imatinib Fresenius Kabi.
  • Swallow the tablets whole with a large glass of water.

If you can not swallow the tablets, you can slurry them in either a glass of non-carbonated water or apple juice:

  • Take about 50 ml for each 100 mg tablet.
  • Stir with a spoon until the tablets have completely dissolved.
  • Once the tablet has dissolved, immediately drink the entire contents of the glass. Residues of the dissolved tablets may remain in the glass.

How long to take Imatinib Fresenius Kabi?

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

If you take more Imatinib Fresenius Kabi than you should

Contact your doctor immediately if you have accidentally taken too many tablets. You may need medical care. Take the medicine pack with you.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Imatinib Fresenius Kabi

  • 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 Fresenius Kabi can cause your body to bind water (severe fluid retention ).
  • Signs of infection , such as fever, chills, sore throat or sore mouth. Imatinib Fresenius Kabi can reduce the number of white blood cells so that you can get infected more easily .
  • Sudden bleeding or sores (when you have not injured yourself).

Less common (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1000 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 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 ).
  • Impaired hearing.
  • 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).

Has been reported (occurs in 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).
  • Blood clots in small blood vessels (thrombotic microangiopathy).

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 or after stopping imatinib.
  • 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 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 Fresenius Kabi

  • 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 after EXP. The expiration date is the last day of the month.
  • No special storage instructions.
  • 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 mesilate.
  • Each 100 mg tablet contains imatinib mesylate equivalent to 100 mg imatinib.
  • Each 400 mg tablet contains imatinib mesilate equivalent to 400 mg imatinib.
  • The other ingredients are microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), povidone (E1201), crospovidone (Type A) (E1202), anhydrous colloidal silicon (E551), magnesium stearate (E572)
  • The tablet case contains hypromellose (E464), macrogol 400, talc (E553b), red iron oxide (E172), yellow iron oxide (E172)

What the medicine looks like and contents of the pack

Imatinib Fresenius Kabi 100 mg film-coated tablet is a dark yellow to brownish orange, round film-coated tablet 10.1 mm (± 5%) in diameter with a score line on one side and the label “100” on the other side. The tablet can be divided into two equal doses .

Imatinib Fresenius Kabi 400 mg film-coated tablet is a dark yellow to brownish orange, oval film-coated tablet that is 21.6 mm long and 10.6 mm wide (± 5%) with a score line on one side and the label “400” on the other side. The tablet can be divided into two equal doses .

The packs contain 10, 20, 30, 60, 90, 120, 180 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Deutschland GmbH

Else Kröner Straße 1,

61 352 Bad Homburg vdH

Germany

Manufacturer
Remedica Ltd
Acharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus

and

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta

Muhammad Nadeem

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