Glivec 100 mg film-coated tablets

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

1. What Glivec is and what it is used for

Glivec 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.

Glivec 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. Glivec inhibits the growth of these cells.

Glivec 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. Glivec 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. Glivec inhibits the growth of these cells in a certain subset of these diseases.
  • Gastrointestinal stromal cell tumors ( GIST ). GIST is a form of cancer of the stomach and intestines. It occurs through uncontrolled growth in the supporting tissue of these organs.
  • Dermatofibrosarcoma protuberans (DFSP) . DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Glivec 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.

What you need to know before taking Glivec

Do not use this medicine

Glivec 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 Glivec

  • 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 Glivec 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 Glivec:

  • 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 Glivec 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 you take Glivec, 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 Glivec.

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

When you take Glivec, your doctor will regularly check if the medicine works. You will also be given blood samples and weighed regularly.

Children and young people

Glivec 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, GIST, and HES / CEL.

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

Other medicines and Glivec

Tell your doctor or pharmacist if you 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 way Glivec works when taken together. They may increase or decrease the effect of Glivec and either leads to more side effects or make Glivec less effective. Glivec may 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 using this medicine.
  • Glivec is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss the possible risks of taking Glivec 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 Glivec and for 15 days after stopping treatment as it may be harmful to your baby.
  • Patients who are concerned about their fertility when taking Glivec 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.

3. How to take Glivec

Your doctor has prescribed Glivec because you are suffering from a serious illness. Glivec 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 Glivec 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 Glivec to take?

Use for adults

Your doctor will tell you exactly how many tablets of Glivec to take.

  • If you are being treated for CML:
    Depending on your condition the usual starting dose is either 400 mg or 600 mg taken one time a day.
  • If you are being treated for GIST:
    the starting dose is 400 mg taken one time a day.

For KML 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, you should take 400 mg in the morning and 400 mg in the evening.

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

A 400 mg dose can be taken either as 1 tablet of 400 mg or 4 tablets of 100 mg.

A 600 mg dose is taken as 1 tablet of 400 mg plus 2 tablets of 100 mg.

Use for children and adolescents

Your doctor will tell you how many tablets of Glivec to give to your child. The amount of Glivec 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 Glivec?

  • Take Glivec with a meal. It helps protect against stomach problems when you take Glivec.
  • 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 or 200 ml for each 400 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 Glivec?

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

If you take more Glivec 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 Glivec

  • 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. Glivec can cause your body to bind water (severe fluid retention ).
  • Signs of infection , e.g. fever, frostbite, sore throat or sore mouth. Glivec 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 urine, yellowing of the skin or eyes (signs of liver problems).
  • Skin rash, redness with blisters on the 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, vomiting blood, feces or urine, black stools (signs of gastrointestinal disease).
  • Severe urinary incontinence, 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 in 10 people):

  • Headache or fatigue.
  • Nausea, vomiting, diarrhea or indigestion.
  • Rash.
  • Muscle cramps or pain in joints, muscles or bones during treatment with Glivec or after you have stopped taking Glivec.
  • 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 the 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 Glivec

  • 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.
  • Do not store above 30 ° C.
  • Store in the original package. Moisture sensitive.
  • 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 Glivec tablet contains 100 mg of imatinib (as mesylate).
    • Each Glivec tablet contains 400 mg imatinib (as mesylate)
  • The other ingredients are microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate and anhydrous colloidal silica.
  • The tablet cover consists of red iron oxide (E172), yellow iron oxide (E172), macrogol, talc and hypromellose.

What the medicine looks like and contents of the pack

Glivec 100 mg film-coated tablets are very dark yellow to brown-orange round tablets. They are marked with “NVR” on one side and “SA” and a notch on the other side.

Glivec 400 mg film-coated tablets are very dark yellow to brown-orange round tablets. They are marked with “Glivec” on one side.

Glivec 100 mg film-coated tablets are supplied in pack sizes of 20, 60, 120, or 180 tablets.

Glivec 400 mg film-coated tablets are supplied in pack sizes of 10, 30, or 90 tablets.

However, not all of these may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek dd, PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 555
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 SwedenNovartis Sverige ABTel: +46 8 732 32 00
LatviaSIA Novartis BalticsTel: +371 67 887 070 United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370

Other sources of information

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

Muhammad Nadeem

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