GLIVEC 50 mg Hard Capsules

Содержание инструкции

1. Glivec 100 mg hard capsules
   1. What is Glivec and what is it 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. Package contents and other information
2. Glivec 100 mg film-coated tablets, 400 mg film-coated tablets
   1. What is Glivec and what is it 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. Package contents and other information

Glivec 100 mg hard capsules

imatinib

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Glivec and what is it used for

Glivec is a medicine containing an active substance called imatinib. In the diseases listed below
this medicine works by inhibiting the growth of abnormal cells. These include some types of
cancer.

Glivec is indicated in adult and paediatric patients for the treatment of:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of the white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. White blood cells normally help the body fight infections. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Glivec inhibits the growth of these cells.

Glivec is also indicated in adult patients for the treatment of:

• Myelodysplastic/Myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells begin to grow uncontrollably. Glivec inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases where blood cells (called eosinophils) begin to grow uncontrollably. Glivec inhibits the growth of these cells in a certain subtype of these diseases.
• Malignant gastrointestinal stromal tumours (GIST). GIST is a neoplasm of the stomach and intestine. It originates from the uncontrolled growth of cells that support the tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the subcutaneous tissue in which some cells begin to grow uncontrollably. Glivec inhibits the growth of these cells.

If you have any questions about how Glivec works or why it has been prescribed for you,
consult your doctor.

2. What you need to know before taking Glivec

Glivec will only be prescribed by doctors with experience in medicines for the treatment of blood cancers and solid tumors.
Follow all of your doctor's instructions carefully, even if they differ from the general information
contained in this leaflet.

Do not take Glivec

• if you are allergic to imatinib or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, consult your doctor before taking Glivec.

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

Warnings and precautions
Talk to your doctor before taking Glivec:

• if you have or have had liver, kidney or heart problems.
• if you are taking the medicine levothyroxine because your thyroid has been removed.
• if you have ever had or may have an ongoing hepatitis B infection. This is because Glivec can cause hepatitis B to reactivate, which can be fatal in some cases. Patients will be carefully examined by the doctor for signs of this infection before starting treatment.
• if you develop bruising, bleeding, fever, fatigue and confusion while taking Glivec, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA). If you are in any of these situations, consult your doctor before taking Glivec.

During treatment with Glivec you may become more sensitive to the sun. It is important to cover areas
of skin exposed to the sun and use a sunscreen with a high sun protection factor (SPF).
These precautions also apply to children.

During treatment with Glivec, tell your doctor immediatelyif you gain weight very
quickly. Glivec can cause your body to retain water (severe fluid retention).
While you are taking Glivec, your doctor will regularly check if the medicine is working.
You will also have blood tests and be weighed regularly.

Children and adolescents
Glivec is also a treatment for children with CML. There is no experience in children with CML
under the age of 2 years. There is limited experience in children with Ph+ ALL and very limited experience
in children with MDS/MPD, DFSP, GIST and HES/LEC.
Some children and adolescents taking Glivec may experience slower than normal growth.
The doctor will check growth at regular intervals.

Other medicines and Glivec
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription (such as paracetamol) and including
herbal medicines (such as St John's Wort). Some medicines can interfere with
the effect of Glivec when taken together. They can increase or decrease the effect of Glivec leading
to an increase in side effects or making Glivec less effective. Glivec can do the same for
other medicines.
Tell your doctor if you are using medicines that prevent blood clots.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
• Glivec is not recommended during pregnancy unless it is strictly necessary as it may harm the baby. The doctor will discuss the possible risks of taking Glivec during pregnancy with you.
• Women who could become pregnant are advised to use effective contraception during treatment and for 15 days after the end of treatment.
• Do not breastfeed during treatment with Glivec and for 15 days after the end of treatment, as it may harm the baby.
• Patients who are concerned about their fertility during treatment with Glivec are advised to consult their doctor.

Driving and operating machinery
You may experience dizziness, drowsiness or blurred vision while taking this
medicine. If this happens, do not drive a vehicle or operate tools or machinery until you feel
well again.

3. How to take Glivec

Your doctor has prescribed Glivec because you suffer from a serious condition. Glivec can help you
fight this condition.
However, take this medicine following exactly the instructions of your doctor or
pharmacist. It is important that you do so until your doctor or pharmacist tells you otherwise. If you have doubts
consult your doctor or pharmacist.
Do not stop taking Glivec unless your doctor tells you to. If you are unable to take the
medicine as prescribed by your doctor or feel you no longer need it, contact your doctor
immediately.

How much Glivec to take
Use in adults
Your doctor will tell you exactly how many Glivec capsules you will need to take.

• If you are being treated for CML:Depending on your condition, the usual initial dose is 400 mg or 600 mg:
• 400 mgto be taken as 4 capsules oncea day
• 600 mgto be taken as 6 capsules oncea day.
• If you are being treated for GIST:The initial dose is 400 mg, to be taken as 4 capsules oncea day.

For CML and GIST, your doctor may prescribe a higher or lower dosage depending on how
you respond to treatment. If the daily dose is 800 mg (8 capsules), you should take 4 capsules in the
morning and 4 capsules in the evening.

• If you are being treated for Ph+ ALL:The initial dose is 600 mg to be taken as 6 capsules oncea day.
• If you are being treated for MSD/MPD:The initial dose is 400 mg, to be taken as 4 capsules oncea day.
• If you are being treated for HES/LEC:The initial dose is 100 mg, to be taken as one capsule oncea day. Your doctor may decide to increase the dosage to 400 mg, to be taken as 4 capsules oncea day based on your response to treatment.
• If you are being treated for DFSP:The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.

Use in children and adolescents
Your doctor will tell you how many Glivec capsules should be given to the child. The amount of Glivec
given will depend on the child’s condition, weight and height. The total daily
dose should not exceed 800 mg in children with CML and 600 mg in children with Ph+ ALL. The
treatment can be given to the child as a single daily dose or, alternatively, the
daily dose can be divided into two administrations (half in the morning and half in the evening).

When and how to take Glivec

• Take Glivec with a meal.This will help protect your stomach when you take Glivec.
• Swallow the capsules whole with a large glass of water.Do not open or break the capsules unless you have difficulty swallowing (e.g. in children).
• If you are unable to swallow the capsules, you can open them and pour the powder into a glass of still water or apple juice.
• If you are pregnant or may become pregnant and are trying to open the capsules, you must handle the contents with caution to avoid contact with the skin and eyes or inhalation. You should wash your hands immediately after opening the capsules.

For 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
If you have accidentally taken too many capsules, contact your doctor immediately. You may need
medical assistance. Bring the medicine packaging with you.

If you forget to take Glivec

• If you forget a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose.
• Then continue with the normal dosage.
• Do not take a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These are generally mild to moderate.

Some side effects can be serious. Tell your doctor immediately if you experience
any of the following effects:
Very common(may affect more than 1 in 10 people) or common(may affect up to
1 in 10 people):

• Rapid weight gain. Glivec may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth sores. Glivec can reduce the number of white blood cells so you may be more likely to get infections.
• Unexpected bleeding or bruising (when you haven’t 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 faint, dizzy or fainting (signs of low blood pressure).
• Feeling unwell (nausea), with loss of appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in the amount of urine, feeling thirsty (signs of kidney problems).
• Feeling unwell (nausea) with diarrhea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Paleness, feeling tired and short of breath, and dark urine (signs of low red blood cell counts).
• Eye pain or worsening vision, bleeding in the eyes.
• Bone or joint pain (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numb or cold toes or fingers (signs of Raynaud’s syndrome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Hearing problems.
• Muscle weakness and muscle spasms with an abnormal heartbeat (signs of changes in potassium levels in the blood).
• Bruising (lividi).
• Stomach pain with feeling unwell (nausea).
• Muscle spasms with fever, reddish-brown urine, muscle pain or weakness (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with the ovaries and uterus).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint disorders 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).

Not known(frequency cannot be estimated from the available data):

• Combination of a widespread severe skin reaction, feeling unwell, fever, increased number of certain types of white blood cells or yellowing of the skin or eyes (signs of jaundice i.e. a liver problem) with shortness of breath, chest pain/discomfort, significant decrease in urine production and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

If you experience any of the effects described above, tell your doctor immediately.
Other side effects may include:
Very common(may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling unwell (nausea), vomiting, diarrhea or indigestion.
• Rash.
• Muscle cramps or joint or muscle or bone pain, during treatment with Glivec or after stopping taking Glivec.
• Swelling for example around the ankles or swollen eyes.
• Weight gain. If any of these effects occur severely, tell your doctor.

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

• Anorexia, weight loss or altered sense of taste.
• Feeling dizzy or weak.
• Sleep disorders (insomnia).
• Eye discharge with itching, redness and swelling (conjunctivitis), increased tearing or blurred vision.
• Nosebleeds.
• Abdominal pain or bloating, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth sores.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats. If any of these effects occur severely, tell your doctor.

Uncommon(may affect up to 1 in 100 people):

• Red, painful nodules on the skin, skin pain, redness of the skin (inflammation of the subcutaneous fatty tissue).
• Cough, runny or blocked nose, feeling of fullness or pain when pressing on the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache felt as a throbbing or pulsating pain, usually on one side of the head and often accompanied by nausea, vomiting and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation when passing urine, increased body temperature, groin or pelvic pain, red or brown or cloudy urine (signs of urinary tract infection).
• Pain and swelling of the joints (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which prevents you from carrying out your normal activities (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Drowsiness/torpor/excessive sleepiness.
• Tremor or shaky movements.
• Memory problems.
• Irresistible urge to move the legs (restless legs syndrome).
• Hearing noises in the ears (e.g. ringing, buzzing) that have no external source (tinnitus).
• High blood pressure (hypertension).
• Burping.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Changes in skin color.
• Fragile nails.
• Red bumps or pimples with a white tip around the hair roots, possibly with pain, itching or burning sensation (signs of inflammation of the hair follicles also called folliculitis).
• Rash with scaling or flaking (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull and/or heavy pain in the testicles or lower abdomen, pain when passing urine, sexual intercourse or ejaculation, blood in the urine (signs of testicular edema).
• Inability to get or maintain an erection (erectile dysfunction).
• Heavy or irregular periods.
• Difficulty reaching/maintaining sexual excitement.
• Decreased sexual desire.
• Breast pain.
• General feeling of being unwell (malaise).
• Viral infection such as cold sores.
• Back pain from kidney disease.
• Increased frequency of urination.
• Increased appetite.
• Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, dark stools (signs of stomach ulcer).
• Stiffness of joints and muscles.
• Abnormal laboratory test results. If any of these effects occur severely, tell your doctor.

Rare(may affect up to 1 in 1,000 people):

• Confusion.
• An episode of spasm(s) and reduced consciousness (convulsions).
• Changes in nail color.

Not known(frequency cannot be estimated from the available data):

• Redness and/or swelling of the palms of the hands and soles of the feet which may be accompanied by a sensation of tingling and burning pain.
• Painful and/or blistering skin lesions.
• Slowed growth in children and adolescents. If any of these effects occur severely, tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

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 that is stated on the pack after Exp.
• Do not store at a temperature above 30 °C.
• Store in the original package to protect the medicine from moisture.
• Do not use if the package is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glivec contains

• The active ingredient is imatinib mesylate. Each Glivec capsule contains 100 mg of imatinib (as mesylate).
• The other ingredients are microcrystalline cellulose, crospovidone, magnesium stearate and anhydrous colloidal silica. The capsule shell consists of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171). The printing ink consists of red iron oxide (E172) and shellac.

Description of Glivec’s appearance and package contents
Glivec 100 mg capsules are orange to orange-greyish in colour and with the inscription
“NVR SI”. They contain a powder ranging in colour from white to yellow.
They are supplied in packs of 24, 48, 96, 120 or 180 capsules, but not all pack sizes may
be available in the country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Sandoz S.R.L.
Str. Livezeni nr. 7A
540472, Targu Mures
Romania
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 555

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu

Glivec 100 mg film-coated tablets, 400 mg film-coated tablets

imatinib

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Glivec and what is it used for

Glivec is a medicine containing an active substance called imatinib. In the diseases listed below
this medicine works by inhibiting the growth of abnormal cells. These include some types of
cancer.

Glivec is indicated in adult and paediatric patients for the treatment of:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of the white blood cells. White blood cells normally help the body to fight infections. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. White blood cells normally help the body to fight infections. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Glivec inhibits the growth of these cells.

Glivec is also indicated in adult patients for the treatment of:

• Myelodysplastic/Myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells begin to grow uncontrollably. Glivec inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases where blood cells (called eosinophils) begin to grow uncontrollably. Glivec inhibits the growth of these cells in a certain subtype of these diseases.
• Malignant gastrointestinal stromal tumours (GIST). GIST is a neoplasm of the stomach and intestine. It originates from the uncontrolled growth of cells that support the tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the subcutaneous tissue in which some cells begin to grow uncontrollably. Glivec inhibits the growth of these cells.

If you have any questions about how Glivec works or why it has been prescribed to you,
consult your doctor.

2. What you need to know before taking Glivec

Glivec will only be prescribed by doctors with experience in medicines for the treatment of blood cancers and solid tumors.
Follow all of your doctor's instructions carefully, even if they differ from the general information
contained 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 is the case, consult your doctor before taking Glivec.

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

Warnings and precautions
Talk to your doctor before taking Glivec:

• if you have or have had liver, kidney or heart problems.
• if you are taking the medicine levothyroxine because your thyroid has been removed.
• if you have ever had or may have an ongoing hepatitis B infection. This is because Glivec can cause reactivation of hepatitis B, which in some cases can be fatal. Patients will be carefully examined by the doctor for signs of this infection before starting treatment.
• if you develop bruising, bleeding, fever, fatigue and confusion while taking Glivec, contact your doctor. This may be a sign of blood vessel damage known as thrombotic microangiopathy (TMA). If you are in any of these situations, consult your doctor before taking Glivec.

During treatment with Glivec you may become more sensitive to the sun. It is important to cover the areas
of skin exposed to the sun and use a sunscreen with a high sun protection factor (SPF).
These precautions also apply to children.

During treatment with Glivec, tell your doctor immediatelyif you gain weight very
quickly. Glivec can cause your body to retain water (severe fluid retention).
While you are taking Glivec, your doctor will regularly check if the medicine is effective.
You will also have blood tests and be weighed regularly.

Children and adolescents
Glivec is also a treatment for children with CML. There is no experience in children with CML
under the age of 2 years. There is limited experience in children with Ph+ ALL and very limited experience
in children with MDS/MPD, DFSP, GIST and HES/LEC.
Some children and adolescents taking Glivec may experience slower than normal growth.
The doctor will check growth at regular intervals.

Other medicines and Glivec
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription (such as paracetamol) and including
herbal medicines (such as St. John's Wort). Some medicines may interfere with
the effect of Glivec when taken together. They may increase or decrease the effect of Glivec leading to
an increase in side effects or making Glivec less effective. Glivec can do the same in
relation to other medicines.
Tell your doctor if you are using medicines that prevent blood clots from forming.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
• Glivec is not recommended during pregnancy unless it is strictly necessary as it may harm the baby. The doctor will discuss the possible risks of taking Glivec during pregnancy with you.
• Women who can become pregnant are advised to use effective contraception during treatment and for 15 days after the end of treatment.
• Do not breastfeed during treatment with Glivec and for 15 days after the end of treatment, as it may harm the baby.
• Patients who are concerned about their fertility during treatment with Glivec are advised to consult their doctor.

Driving and using machines
You may experience dizziness, drowsiness or blurred vision while taking this
medicine. If this happens, do not drive a vehicle or use tools or machines until you feel
well again.

3. How to take Glivec

Your doctor has prescribed Glivec because you suffer from a serious condition. Glivec can help you
fight this condition.
However, take this medicine following exactly the instructions of your doctor or
pharmacist. It is important that you do so until your doctor or pharmacist tells you otherwise. If you have doubts
consult your doctor or pharmacist.
Do not stop taking Glivec unless your doctor tells you to. If you are unable to take the
medicine as prescribed by your doctor or feel you no longer need it, contact your doctor
immediately.

How much Glivec to take
Use in adults
Your doctor will tell you exactly how many Glivec tablets you need to take.

• If you are being treated for CML:Depending on your condition, the usual initial dose is 400 mgor 600 mgto be taken oncea day.
• If you are being treated for GIST:The initial dose is 400 mg, to be taken oncea day.

For CML and GIST, your doctor may prescribe a higher or lower dosage depending on how
you respond to treatment. If the daily dose is 800 mg, you will need to take 400 mg in the morning and
400 mg in the evening.

• If you are being treated for Ph+ ALL:The initial dose is 600 mg to be taken oncea day.
• If you are being treated for MDS/MPD:The initial dose is 400 mg, to be taken oncea day.
• If you are being treated for HES/LEC:The initial dose is 100 mg, to be taken oncea day. Your doctor may decide to increase the dosage to 400 mg, to be taken oncea day, based on your response to treatment.
• If you are being treated for DFSP:The dose is 800 mg per day, to be taken as 400 mg in the morning and 400 mg in the evening.

A dose of 400 mg can be taken as one 400 mg tablet or 4 100 mg tablets.
A dose of 600 mg can be taken as one 400 mg tablet plus 2 100 mg tablets or
as one 400 mg tablet plus half a 400 mg tablet.
The tablets can be split in half by breaking them along the fracture line.

Use in children and adolescents
Your doctor will tell you how many Glivec tablets should be given to the child. The amount of Glivec
given will depend on the child's condition, weight and height. The total daily
dose should not exceed 800 mg in children with CML and 600 mg in children with Ph+ ALL. The
treatment can be given to the child as a single daily dose or, alternatively, the
daily dose can be divided into two administrations (half in the morning and half in the evening)

When and how to take Glivec

• Take Glivec with a meal.This will help protect your stomach when you take Glivec.
• Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still 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 are completely dissolved.
• Once the tablet has dissolved, drink everything in the glass immediately. Residues of the dissolved tablets can be left 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
If you have accidentally taken too many tablets, contact your doctor immediately. You may need
medical assistance. Bring the medicine packaging with you.

If you forget to take Glivec

• If you forget a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose.
• Then continue with the normal dosage.
• Do not take a double dose to make up for a missed dose.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These are generally mild to moderate.

Some side effects can be serious. Tell your doctor immediately if you experience
any of the following effects:
Very common(may affect more than 1 in 10 people) or common(may affect up to
1 in 10 people):

• Rapid weight gain. Glivec may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Glivec can reduce the number of white blood cells so you may be more likely to get infections.
• Unexpected bleeding or bruising (when you haven’t injured yourself).

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

• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, difficulty breathing or painful breathing (signs of lung problems).
• Feeling lightheaded, dizzy or fainting (signs of low blood pressure).
• Feeling unwell (nausea), with loss of appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
• Skin rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in the amount of urine, feeling thirsty (signs of kidney problems).
• Feeling unwell (nausea) with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems).
• Severe headache, weakness or paralysis of the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Paleness, feeling tired and short of breath, and dark urine (signs of low red blood cell counts).
• Eye pain or worsening vision, bleeding in the eyes.
• Bone or joint pain (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numb or cold toes or fingers (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Hearing problems.
• Muscle weakness and muscle spasms with an abnormal heartbeat (signs of changes in potassium levels in the blood).
• Bruising (lividi).
• Stomach pain with feeling unwell (nausea).
• Muscle spasms with fever, reddish-brown urine, pain or muscle weakness (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with the ovaries and uterus).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint disorders 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).

Not known(frequency cannot be estimated from the available data):

• Combination of a widespread severe skin reaction, feeling unwell, fever, increased number of certain types of white blood cells or yellowing of the skin or eyes (signs of jaundice i.e. a liver problem) with shortness of breath, chest pain/discomfort, significant decrease in urine production and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

If you experience any of the effects described above, tell your doctor immediately.
Other side effects may include:
Very common(may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling unwell (nausea), vomiting, diarrhea or indigestion.
• Skin rash.
• Muscle cramps or joint or muscle or bone pain, during treatment with Glivec or after stopping taking Glivec.
• Swelling for example around the ankles or swollen eyes.
• Weight gain. If any of these effects occur severely, tell your doctor.

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

• Anorexia, weight loss or changes in taste.
• Feeling dizzy or weak.
• Sleep disorders (insomnia).
• Eye discharge with itching, redness and swelling (conjunctivitis), increased tearing or blurred vision.
• Nosebleeds.
• Abdominal pain or bloating, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats. If any of these effects occur severely, tell your doctor.

Uncommon(may affect up to 1 in 100 people):

• Red, painful nodules on the skin, skin pain, redness of the skin (inflammation of the subcutaneous fatty tissue).
• Cough, runny or blocked nose, feeling of fullness or pain when pressing on the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache felt as a throbbing or pulsating pain, usually on one side of the head and often accompanied by nausea, vomiting and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation during urination, increased body temperature, groin or pelvic pain, red or brown or cloudy urine (signs of urinary tract infection).
• Pain and swelling of the joints (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which prevents you from carrying out your normal activities (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Drowsiness/torpor/excessive sleepiness.
• Tremor or shaky movements.
• Memory problems.
• Uncontrollable urge to move the legs (restless legs syndrome).
• Hearing noises in the ears (e.g. ringing, buzzing) that have no external source (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Changes in skin color.
• Fragile nails.
• Red bumps or white-tipped pimples around the hair roots, with possible pain, itching or burning sensation (signs of inflammation of the hair follicles also called folliculitis).
• Skin rash with scaling or exfoliation (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull and/or heavy pain in the testicles or lower abdomen, pain during urination, sexual intercourse or ejaculation, blood in the urine (signs of testicular edema).
• Inability to get or maintain an erection (erectile dysfunction).
• Heavy or irregular periods.
• Difficulty reaching/maintaining sexual excitement.
• Decreased sexual desire.
• Breast pain.
• General feeling of being unwell (malaise).
• Viral infection such as cold sores.
• Lower back pain from kidney disease.
• Increased frequency of urination (micturition).
• Increased appetite.
• Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, dark stools (signs of stomach ulcer).
• Stiffness of joints and muscles.
• Abnormal laboratory test results. If any of these effects occur severely, tell your doctor.

Rare(may affect up to 1 in 1,000):

• Confusion.
• An episode of spasm(s) and reduced consciousness (convulsions).
• Changes in nail color.

Not known(frequency cannot be estimated from the available data):

• Redness and/or swelling of the palms of the hands and soles of the feet which may be accompanied by a sensation of tingling and burning pain.
• Painful and/or blistering skin lesions.
• Slowed growth in children and adolescents. If any of these effects occur severely, tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

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 that is stated on the pack after Exp.
• Storage temperature
• Glivec 100 mg film-coated tablets: Do not store at a temperature above 30 °C.
• Glivec 400 mg film-coated tablets: Store at a temperature below 25 °C.
• Store in the original package to protect the medicine from moisture.
• Do not use if the package is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glivec contains

• The active ingredient is imatinib mesylate.
• Each 100 mg tablet of Glivec contains 100 mg of imatinib (as mesylate).
• Each 400 mg tablet of Glivec contains 400 mg of imatinib (as mesylate).
• The other ingredients are microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate and anhydrous colloidal silicon dioxide.
• The tablet coating consists of red iron oxide (E172), yellow iron oxide (E172), macrogol, talc and hypromellose.

Description of Glivec’s appearance and package contents
Glivec 100 mg film-coated tablets are round tablets of a colour ranging from
very dark yellow to orange-brownish. They have “NVR” on one side and “SA” and a fracture line
on the other side.
Glivec 400 mg film-coated tablets are oval tablets of a colour ranging from very dark yellow
to orange-brownish. They have “400” on one side and a fracture line on the other side with
“SL” on each side of the fracture line.
Glivec 100 mg film-coated tablets are supplied in packs of 20, 60, 120 or
180 tablets.
Glivec 400 mg film-coated tablets are supplied in packs of 10, 30 or
90 tablets.
Not all pack sizes may be available in each country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia
Lek d.d, PE PROIZVODNJA LENDAVA
Trimlini 2D
Lendava, 9220
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 555

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu