Patient Information Leaflet: Information for the User

Imatinib Teva 100 mg film-coated tablets

imatinib
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Imatinib Teva is and what it is used for
What you need to know before taking Imatinib Teva
How to take Imatinib Teva
Possible side effects
How to store Imatinib Teva
Contents of the pack and other information

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

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine
works by inhibiting the growth of abnormal cells in the diseases listed below. These include certain
types of cancer.
Imatinib Teva is indicated in adult and pediatric patients for the treatment of :

Chronic myeloid leukaemia (CML) . Leukaemia is a cancer of white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukaemia is a type 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 white blood cells. White blood cells normally help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also indicated in adult patients for the treatment of:

Myelodysplastic/myeloproliferative diseases (MDS/MPD) . These are a group of blood disorders in which certain blood cells begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells in certain subtypes of these diseases.
Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) . These are blood disorders in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells in a specific subtype of these diseases.
Malignant gastrointestinal stromal tumours (GIST) . GIST is a tumour of the stomach and intestine. It arises 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 certain cells begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells.

In the remainder of this patient information leaflet, abbreviations will be used when referring to these diseases.
If you have any questions about how Imatinib Teva works or why it has been prescribed for you,
please consult your doctor.

2. What you need to know before taking Imatinib Teva

Imatinib Teva will only be prescribed by a doctor experienced in medicines for the treatment of
blood cancers or solid tumours.
Carefully follow all instructions given by your doctor, even if they differ from the general information
contained in this leaflet.
Do not take Imatinib Teva:

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 Imatinib Teva.
If you think you may be allergic but are unsure, seek advice from your doctor.
Warnings and precautions
Talk to your doctor before taking Imatinib Teva:

if you have or have had liver, kidney or heart problems.
if you are taking the medicine levothyroxine because your thyroid gland has been removed.
if you have ever had or may currently have a hepatitis B infection. This is because Imatinib Teva may cause reactivation of hepatitis B, which in some cases can be fatal. Your doctor will carefully monitor you for signs of this infection before starting treatment.
if you develop bruising, bleeding, fever, fatigue or confusion while taking Imatinib Teva, contact your doctor immediately. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

If any of these apply to you, consult your doctor before taking Imatinib Teva.
During treatment with Imatinib Teva, you may become more sensitive to sunlight. It is important to cover
exposed areas of skin and to use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.
During treatment with Imatinib Teva, inform your doctor immediately if you gain weight rapidly. Imatinib Teva may cause your body to retain fluid (severe fluid retention).
While you are taking Imatinib Teva, your doctor will regularly monitor whether the medicine is working. You will also have regular blood tests and be weighed regularly.
Children and adolescents
Imatinib Teva is also a treatment for children with CML. There is no experience in children with CML under 2 years of age. Experience is limited in children with Ph+ ALL and very limited in children with MDS/MPD, DFSP, GIST and HES/LEC.
Some children and adolescents taking Imatinib Teva may have slower than normal growth. Your doctor will monitor growth at regular intervals.
Other medicines and Imatinib Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription (such as paracetamol), and including herbal remedies (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, leading to an increase in side effects or making Imatinib Teva less effective.
Imatinib Teva may have similar effects on other medicines.
Tell your doctor if you are taking medicines that prevent blood clots from forming.
Pregnancy, breastfeeding and fertility

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Imatinib Teva is not recommended during pregnancy unless strictly necessary, as it may harm the unborn child. Your doctor will discuss with you the potential risks of taking Imatinib Teva during pregnancy.
Women who could become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
Do not breastfeed during treatment with Imatinib Teva and for 15 days after stopping treatment, as it may harm the breastfed infant.
Patients concerned about fertility during treatment with Imatinib Teva are advised to consult their doctor.

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

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can
help you fight this condition.
However, take this medicine exactly as instructed by your doctor, pharmacist, or nurse. It is important that you do so until your doctor, pharmacist, or
nurse tells you otherwise. If you have any doubts, consult your doctor, pharmacist, or nurse.
Do not stop taking Imatinib Teva 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 Imatinib Teva to take
Use in adults
Your doctor will tell you exactly how many Imatinib Teva tablets you should 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 to be taken as 4 tablets once daily,
- 600 mg to be taken as 6 tablets once daily.
If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once daily.

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

If you are being treated for Ph+ ALL: The starting dose is 600 mg, to be taken as 6 tablets once daily.
If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 4 tablets once daily.
If you are being treated for HES/CEL: The starting dose is 100 mg, to be taken as 1 tablet once daily. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once daily, based on your response to treatment.
If you are being treated for DFSP: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.

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

When and how to take Imatinib Teva

Take Imatinib Teva with a meal. This will help protect your stomach when taking Imatinib Teva.
Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you may dissolve them in a glass of still water or apple juice:

Use approximately 50 ml of liquid for each 100 mg tablet.
Stir with a spoon until the tablets have completely dissolved.
Once the tablet has dissolved, drink the entire contents of the glass immediately. Residual particles from the dissolved tablets may remain in the glass.

The tablet may be divided into equal parts.

How long to take Imatinib Teva
Continue taking Imatinib Teva every day for as long as your doctor tells you to.

If you take more Imatinib Teva than you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may need
medical assistance. Take the medicine pack with you.

If you forget to take Imatinib Teva

If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Then continue with your regular dosing schedule.
Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These are generally mild to moderate.
Some side effects may be serious. Inform your doctor immediately if you experience
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 Teva may cause your body to retain water (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib Teva may reduce the number of white blood cells, so you may get infections more easily.
Unexpected bleeding or bruising (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 of dizziness, lightheadedness, or fainting (signs of low blood pressure).
Feeling unwell (nausea), with loss of appetite, dark-coloured urine, or yellowing of the skin or eyes (signs of liver problems).
Skin rash, skin redness with blisters on the lips, eyes, skin, or mouth, skin peeling, 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).
Marked decrease in urine output, feeling thirsty (signs of kidney problems).
Feeling unwell (nausea) with diarrhoea and vomiting, abdominal pain, or fever (signs of intestinal problems).
Severe headache, weakness or paralysis of 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-coloured urine (signs of low red blood cell levels).
Eye pain or worsening of vision, bleeding in the eyes.
Bone or joint pain (signs of osteonecrosis).
Blisters on the skin or mucous membranes (signs of pemphigus).
Numbness or coldness in fingers or toes (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 blood potassium levels).
Bruising (bruises).
Stomach pain with feeling unwell (nausea).
Muscle cramps with fever, red-brown urine, muscle pain or weakness (signs of muscle problems).
Pelvic pain sometimes with nausea and vomiting, vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with ovaries and uterus).
Nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness and/or joint problems 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, marked decrease in urine production and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
Chronic kidney failure.
Reactivation of hepatitis B infection if you have previously had hepatitis B (a liver infection).

If you experience any of the above effects, inform 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, diarrhoea, or indigestion.
Skin rash.
Muscle cramps or joint, muscle, or bone pain during treatment with Imatinib Teva or after stopping Imatinib Teva.
Swelling, for example around the ankles or puffy eyes.
Weight gain. If any of these effects becomes severe, inform your doctor.

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

Loss of appetite, weight loss, or taste disturbances.
Feeling dizzy or weak.
Sleep disorders (insomnia).
Eye discharge with itching, redness, and swelling (conjunctivitis), increased tear production, or blurred vision.
Nosebleeds.
Abdominal pain or swelling, flatulence, heartburn, or constipation.
Itching.
Unusual hair loss or thinning.
Numbness in hands or feet.
Mouth ulcers.
Joint pain with swelling.
Dry mouth, dry skin, or dry eyes.
Reduced or increased skin sensitivity.
Hot flushes, chills, or night sweats. If any of these effects becomes severe, inform your doctor.

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

Cough, runny or blocked nose, feeling of heaviness or pain when pressing 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 pulsating pain or throbbing sensation, 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, brown, or cloudy urine (signs of urinary tract infection).
Joint pain and swelling (signs of arthralgia).
Persistent feeling of sadness and loss of interest, preventing you from carrying out your normal activities (signs of depression).
A feeling of apprehension and worry together with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
Drowsiness/lethargy/excessive sleepiness.
Tremor or shaky movements (tremor).
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.
Change in skin colour.
Brittle nails.
Red bumps or white-headed pimples around hair roots, possibly with pain, itching, or burning sensation (signs of inflammation of hair follicles, also called folliculitis).
Skin rash with peeling or shedding (exfoliative dermatitis).
Breast enlargement (can occur in men or women).
Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain during urination, sexual intercourse, or ejaculation, blood in the urine (signs of testicular oedema).
Inability to achieve or maintain an erection (erectile dysfunction).
Heavy or irregular menstrual periods.
Difficulty achieving/maintaining sexual arousal.
Decreased sexual desire.
Nipple pain.
General feeling of being unwell (malaise).
Viral infection such as cold sores.
Lower back pain due to 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-coloured stools (signs of stomach ulcer).
Stiffness of joints and muscles.
Abnormal laboratory test results.
Painful red nodules on the skin, skin pain, skin redness (inflammation of the subcutaneous fatty tissue). If any of these effects becomes severe, inform your doctor.

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

Confusion.
Change in nail colour. If any of these effects becomes severe, inform your doctor.

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 tingling and painful burning.
Painful skin lesions and/or blister formation.
Slowed growth in children and adolescents. If any of these effects becomes severe, inform your doctor.

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

5. How to store Imatinib Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp".
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not use if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via 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 Imatinib Teva contains

The active substance is imatinib (as mesilate).
Each tablet of Imatinib Teva contains 100 mg of imatinib (as mesilate).
The other components are dibasic calcium phosphate, crospovidone and magnesium stearate.
The tablet coating consists of partially hydrolysed polyvinyl alcohol, macrogol 3350, yellow iron oxide (E172), talc, titanium dioxide (E171) and red iron oxide (E172).

Description of the appearance of Imatinib Teva and contents of the pack
Imatinib Teva 100 mg film-coated tablets are film-coated tablets ranging in colour from very dark yellow to brownish orange, with a breakline on one side. The tablet is marked with “IT” and “1” on each side of the breakline. The diameter of the tablets is approximately 9 mm.
Imatinib Teva 100 mg film-coated tablets are available in packs of 60 or 120 film-coated tablets in blister packs.
Imatinib Teva 100 mg film-coated tablets are also available in packs of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in unit dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
74770 Opava-Komarov
Czech Republic
TEVA PHARMA, S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza
Spain
Merckle GmbH
Graf-Arco-Str. 3, 89079 Ulm
Germany
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Krakow
Poland
PLIVA Croatia Ltd.
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 Ireland
Tel: +44 2075407117

Deutschland Nederland
AbZ-Pharma GmbH Teva Nederland B.V.
Tel: +49 73140205 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

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

Package leaflet: Information for the user

Imatinib Teva 400 mg film-coated tablets

imatinib
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Imatinib Teva is and what it is used for
What you need to know before taking Imatinib Teva
How to take Imatinib Teva
Possible side effects
How to store Imatinib Teva
Contents of the pack and other information

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

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine
works by inhibiting the growth of abnormal cells in the conditions listed below. These include certain
types of cancer.
Imatinib Teva is indicated in adult and pediatric patients for the treatment of:

Chronic myeloid leukemia (CML). Leukemia is a cancer of white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Leukemia is a cancer of white blood cells. White blood cells normally help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also indicated in adult patients for the treatment of:

Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood disorders in which certain blood cells begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells in certain subtypes of these diseases.
Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells in a specific subtype of these diseases.
Malignant gastrointestinal stromal tumors (GIST). GIST is a tumor of the stomach and intestine. It arises from uncontrolled growth of cells supporting the tissues of these organs.
Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumor of subcutaneous tissue in which certain cells begin to grow uncontrollably. Imatinib Teva inhibits the growth of these cells.

In the remainder of this patient information leaflet, abbreviations will be used when referring to these conditions.
If you have any questions about how Imatinib Teva works or why it has been prescribed for you,
please consult your doctor.

2. What you need to know before taking Imatinib Teva

Imatinib Teva will only be prescribed by a doctor experienced in medicines for the treatment of
blood cancers or solid tumors.
Carefully follow all instructions given by your doctor, even if they differ from the general information
contained in this leaflet.
Do not take Imatinib Teva:

if you are allergic to imatinib or to any of the other ingredients of this medicine (listed in section 6).

if you have or have had liver, kidney, or heart problems.
if you are taking the medicine levothyroxine because your thyroid gland has been removed.
if you have ever had or may currently have hepatitis B infection. This is because Imatinib Teva can cause reactivation of hepatitis B, which in some cases can be fatal. Your doctor will carefully monitor you for signs of this infection before starting treatment.
if you develop bruising, bleeding, fever, fatigue, or confusion while taking Imatinib Teva, contact your doctor immediately. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

If any of these apply to you, consult your doctor before taking Imatinib Teva.
During treatment with Imatinib Teva, you may become more sensitive to sunlight. It is important to cover
areas of skin exposed to sunlight and to use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.
During treatment with Imatinib Teva, inform your doctor immediately if you gain weight rapidly. Imatinib Teva may cause your body to retain fluid (severe fluid retention).
While taking Imatinib Teva, your doctor will regularly monitor whether the medicine is working. You will also have regular blood tests and be weighed regularly.
Children and adolescents
Imatinib Teva is also a treatment for children with CML. There is no experience in children with CML under 2 years of age. Experience is limited in children with Ph+ ALL and very limited in children with MDS/MPD, DFSP, GIST, and HES/LEC.
Inform your doctor if you are taking medicines that prevent blood clots from forming.
Some children and adolescents taking Imatinib Teva may grow more slowly than normal. Your doctor will monitor growth at regular intervals.
Other medicines and Imatinib Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (such as paracetamol), and including herbal remedies (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, leading to an increased risk of side effects or making Imatinib Teva less effective.
Imatinib Teva may have similar effects on other medicines.
Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Imatinib Teva is not recommended during pregnancy unless absolutely necessary, as it may harm the unborn child. Your doctor will discuss with you the potential risks of taking Imatinib Teva during pregnancy.
Women who could become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
Do not breastfeed during treatment with Imatinib Teva and for 15 days after stopping treatment, as it may harm the breastfed infant.
Patients concerned about fertility during treatment with Imatinib Teva are advised to consult their doctor.

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

3. How to take Imatinib Teva

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

How much Imatinib Teva to take
Use in adults
Your doctor will tell you exactly how many Imatinib Teva tablets you should 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 as one tablet taken once daily,
- 600 mg as one 400 mg tablet plus two 100 mg tablets, or as one and a half 400 mg tablets, taken once daily.
If you are being treated for GIST: The starting dose is 400 mg, taken as one tablet once daily.

For both CML and GIST, your doctor may prescribe a higher or lower dose depending on your response to treatment. If the daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.

If you are being treated for Ph+ ALL:
The starting dose is 600 mg, taken as one 400 mg tablet plus two 100 mg tablets, or as one and a half 400 mg tablets, once daily.
If you are being treated for MDS/MPD: The starting dose is 400 mg, taken as one tablet once daily.
If you are being treated for HES/CEL: The starting dose is 100 mg, taken as one 100 mg tablet once daily. Your doctor may decide to increase the dose to 400 mg, taken as one tablet once daily, depending on your response to treatment.
If you are being treated for DFSP: The dose is 800 mg per day (2 tablets), taken as one tablet in the morning and one tablet in the evening.

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

When and how to take Imatinib Teva

Take Imatinib Teva with food. This will help protect your stomach when taking Imatinib Teva.
Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you may dissolve them in a glass of still water or apple juice:

Use about 200 ml for each 400 mg tablet.
Stir with a spoon until the tablets are completely dissolved.
Once the tablet has dissolved, drink the entire contents of the glass immediately. Residual particles from the dissolved tablets may be left in the glass.

The tablet may be divided into equal parts.

How long to take Imatinib Teva
Continue taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may need medical assistance. Bring the medicine pack with you.

If you forget to take Imatinib Teva

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Then continue with your regular dosing schedule.
Do not take a double dose to make up for the missed one.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These are generally mild to moderate.
Some side effects may be serious. Contact your doctor immediately if you experience
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 Teva may cause your body to retain fluid (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat, or mouth ulcers. Imatinib Teva may reduce the number of white blood cells, making you more susceptible to infections.
Unexpected bleeding or bruising (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 of dizziness, lightheadedness, 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, redness with blisters on the lips, eyes, skin, or mouth, skin peeling, 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).
Marked decrease in urine output, feeling thirsty (signs of kidney problems).
Feeling unwell (nausea) with diarrhoea and vomiting, abdominal pain, or fever (signs of intestinal problems).
Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the brain).
Paleness, feeling tired and short of breath, dark urine (signs of low red blood cell levels).
Eye pain or worsening of vision, bleeding in the eyes.
Bone or joint pain (signs of osteonecrosis).
Blisters on the skin or mucous membranes (signs of pemphigus).
Numbness or coldness in fingers or toes (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 abnormal heartbeat (signs of changes in blood potassium levels).
Bruising (contusions).
Stomach pain with feeling unwell (nausea).
Muscle cramps with fever, red-brown urine, muscle pain or weakness (signs of muscle problems).
Pelvic pain sometimes with nausea and vomiting, vaginal bleeding, dizziness or fainting due to low blood pressure (signs of problems with ovaries and uterus).
Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint problems associated with abnormal laboratory test results (e.g. high levels of calcium, uric acid and phosphorus and low levels of phosphate 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. liver problems) with shortness of breath, chest pain/discomfort, marked decrease in urine production, and feeling thirsty, etc. (signs of a treatment-related allergic reaction).
Chronic kidney failure.
Reactivation of hepatitis B infection if you have had hepatitis B in the past (a liver infection).

If you experience any of the effects listed above, contact 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, diarrhoea, or indigestion.
Skin rash.
Muscle cramps or joint, muscle, or bone pain during treatment with Imatinib Teva or after stopping Imatinib Teva.
Swelling, for example around the ankles or puffy eyes.
Weight gain. If any of these effects are severe, contact your doctor.

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

Loss of appetite, weight loss, or taste disturbances.
Feeling dizzy or weak.
Sleep disturbances (insomnia).
Eye discharge with itching, redness, and swelling (conjunctivitis), increased tear production, or blurred vision.
Nosebleeds.
Abdominal pain or swelling, flatulence, heartburn, or constipation.
Itching.
Unusual hair loss or thinning.
Numbness in hands or feet.
Mouth ulcers.
Joint pain with swelling.
Dry mouth, dry skin, or dry eyes.
Reduced or increased skin sensitivity.
Hot flushes, chills, or night sweats. If any of these effects are severe, contact your doctor.

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

Cough, runny or stuffy nose, feeling of pressure or pain over the eyes or sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
Severe headache felt as a pulsating pain or throbbing sensation, 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, brown, or cloudy urine (signs of urinary tract infection).
Joint pain and swelling (signs of arthralgia).
Persistent feeling of sadness and loss of interest, preventing you from carrying out your normal activities (signs of depression).
A feeling of apprehension and worry together with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
Drowsiness/lethargy/excessive sleepiness.
Tremor or shaky movements (tremor).
Memory disturbances.
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.
Change in skin colour.
Brittle nails.
Red bumps or boils with white tips around hair roots, possibly painful, itchy, or with a burning sensation (signs of inflammation of hair follicles, also called folliculitis).
Skin rash with peeling or shedding (exfoliative dermatitis).
Breast enlargement (may occur in men or women).
Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain when passing urine, during sexual intercourse or ejaculation, blood in the urine (signs of testicular swelling).
Inability to achieve or maintain an erection (erectile dysfunction).
Heavy or irregular menstrual periods.
Difficulty achieving/maintaining sexual arousal.
Decreased sexual desire.
Nipple pain.
General feeling of being unwell (malaise).
Viral infection such as cold sores (herpes labialis).
Lower back pain due to 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.
Painful red nodules on the skin, skin pain, skin redness (inflammation of subcutaneous fatty tissue). If any of these effects are severe, contact your doctor.

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

Confusion.
Change in nail colour. If any of these effects are severe, contact your doctor.

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 tingling and painful burning.
Painful skin lesions and/or blistering.
Slowed growth in children and adolescents. If any of these effects are severe, contact your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Imatinib Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not use if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imatinib Teva contains

The active substance is imatinib (as mesilate).
Each tablet of Imatinib Teva contains 400 mg of imatinib (as mesilate).
The other ingredients are dibasic calcium phosphate, crospovidone, and magnesium stearate.
The tablet coating consists of partially hydrolysed polyvinyl alcohol, macrogol 3350, yellow iron oxide (E172), talc, titanium dioxide (E171), and red iron oxide (E172).

Description of the appearance of Imatinib Teva and contents of the pack
Imatinib Teva 400 mg film-coated tablets are film-coated tablets ranging in colour from very dark yellow to brownish-orange, with a score line on one side. The tablet is marked with “IT” and “4” on each side of the score line. The tablets are approximately 20 mm in length and 10 mm in width.
Imatinib Teva 400 mg film-coated tablets are available in packs of 30 or 90 film-coated tablets in blister packs.
Imatinib Teva 400 mg film-coated tablets are also available in packs of 30x1 or 90x1 film-coated tablets in unit dose perforated blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

For further information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117