100 mg Hard capsules
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.

In this leaflet:
1. What Imatinib Grindeks is and what it is used for
2. What you need to know before you use Imatinib Grindeks
3. How to use Imatinib Grindeks
4. Possible side effects
5. How to store Imatinib Grindeks 6. Contents of the pack
and other information

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

Imatinib Grindeks 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 Grindeks is a treatment for adults and children with:

  • 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.In adult patients, Imatinib Grindeks is used to treat a late stage of chronic myeloid leukemia called blast crisis. In children and adolescents, however, it can be used to treat all stages of the disease.
  • 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 Grindeks inhibits the growth of these cells.

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

What you need to know before using Imatinib Grindeks

Do not use Imatinib Grindeks

Imatinib Grindeks will only be prescribed to you by a doctor with medical experience in the treatment of blood cancer or solid tumors.

Follow your doctor’s instructions carefully, even if they differ from the general information in this leaflet.

Do not take Imatinib Grindeks :

  • 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 Grindeks without telling your doctor.

If you think you may be allergic but are not sure, talk to your doctor.

Warnings and cautions

Talk to your doctor before taking Imatinib Grindeks:

  • if you have or have had a liver, kidney or heart disease.
  • if you are taking the medicine levothyroxine because your thyroid has been removed.
  • if you have ever had or may now have a hepatitis B infection . The reason for this is that Imatinib Grindeks can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment
  • if you get bruises, bleeding, fever, get very tired and confused when you take Imatinib Grindeks, 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 Grindeks.

You may become more sensitive to the sun while taking Imatinib Grindeks. 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 Grindeks, tell your doctor immediately if you are gaining weight fast. Imatinib Grindeks can cause your body to bind fluid (severe fluid retention ).

When you are taking Imatinib Grindeks, 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 Grindeks 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 Grindeks may grow more slowly than usual. The doctor will regularly check the growth.

Other medicines and Imatinib Grindeks

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 Grindek when taken together. They may increase or decrease the effect of Imatinib Grindeks and either leads to more side effects or make Imatinib Grindeks less effective. Imatinib Grindeks can do the same for certain 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 taking this medicine.
  • Imatinib Grindeks 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 Grindeks during pregnancy.
  • Women who may become pregnant are advised to use effective contraception during treatment.
  • Do not breast-feed during treatment with Imatinib Grindeks.
  • Patients who are concerned about their fertility when taking Imatinib Grindeks 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 use Imatinib Grindeks

Your doctor has prescribed Imatinib Grindeks because you are suffering from a serious illness. Imatinib Grindeks can help you fight this condition.

Always take this medicine exactly as your doctor or pharmacist has told you. You must 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 Grindeks 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 Grindeks to take?

Use for adults

Your doctor will tell you exactly how many Imatinib Grindeks capsules to take.

  • If you are being treated for KML:The usual dose is 600 mg taken as 6 capsules a once daily.

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 capsules), take 4 capsules in the morning and 4 capsules in the evening.

  • If you are being treated for Ph- positive ALL:starting dose is 600 mg taken as 6 capsules a once daily.
  • If you are being treated for MDS / MPD:starting dose is 400 mg taken as 4 capsules a once daily.
  • If you are being treated for HES / CEL:starting dose is 100 mg taken as a capsule, a once daily. Your doctor may decide to increase the dose of one 400 mg to be taken as 4 capsules a once daily, depending on how you respond to treatment.
  • If you are being treated for DFSP:The dose is 800 mg per day (8 capsules) taken as 4 capsules in the morning and 4 capsules in the evening.

Use for children and adolescents

Your doctor will tell you how many capsules of Imatinib Grindeks should be given to your child. The amount of Imatinib Grindex 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 the treatment of CML and 600 mg for the treatment of Ph + ALL. The treatment can either be given to your child as a single dose or 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 Grindeks?

  • Take Imatinib Grindeks with a meal. It helps to protect against stomach problems when you take Imatinib Grindeks.
  • Swallow the capsules whole with a large glass of water. Do not open or crush the capsules, unless you have difficulty swallowing (eg in children).
  • If you can not swallow the capsules, you can open them and pour the powder into a glass of non-carbonated water or apple juice.
  • If you are a woman of childbearing potential trying to open the capsules, be careful to handle the contents carefully and avoid skin or eye contact or inhalation. Hands should be washed immediately after handling opened capsules.

If you use more Imatinib Grindeks than you should  

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested a medicine, contact a doctor, hospital, or poison information center immediately for risk assessment and advice. You may need medical attention. Take the medicine pack with you.

If you forget to use Imatinib Grindeks

  • 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.

If you stop using Imatinib Grindeks

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

  • Rapid weight gain. Imatinib Grindeks can make your body bind water (severe fluid retention ).
  • Signs of infection , e.g. fever, frostbite, sore throat or sore mouth. Imatinib Grindeks may 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).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 users) : 

  • 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).
  • 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 user in 10):

– Headache or fatigue.

– Nausea, vomiting, diarrhea, or indigestion.

– Skin rash.

– Muscle cramps or pain in joints, muscles, or bones during treatment with Imatinib Grindeks or after you have stopped taking Imatinib Grindeks.

– 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 ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

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 Grindeks

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 specified month.

No special storage instructions.

Do not use this medicine if the packaging is damaged or if there are visible signs of injury.

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 (as mesilate). Each Imatinib Grindek capsule contains imatinib mesilate equivalent to 100 mg imatinib.
  • The other ingredients are: microcrystalline cellulose, colloidal anhydrous silica, crospovidone, talc, magnesium stearate.

Capsule shell (hard): Titanium dioxide (E 171), iron oxide, red (E 172), iron oxide, yellow (E 172), gelatin.

What the medicine looks like and contents of the pack

Imatinib Grindeks 100 mg capsules are brown-orange hard gelatin capsules, 19 mm long. The content is white to light yellow or brownish-yellow powder.

The capsules are packaged in PVC / PVDC / aluminum blister.

10 capsules in each blister.

Pack sizes: 60 or 120 capsules.

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

AS GRINDEKS

Krustpils iela 53, Riga, LV 1057, Latvia

Tel: +371 67083205

Fax: +371 67083505

Email: grindeks@grindeks.lv

Muhammad Nadeem

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