IMATINIB TEVA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Imatinib Teva 400 mg film-coated tablets EFG

Imatinib

Read all of 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.

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Imatinib Teva is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases described below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body to fight infection. Chronic myeloid leukaemia is a type of leukaemia in which some abnormal white blood cells (called myeloid cells) start to grow out of control.

• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Leukaemia is a cancer of the white blood cells. These white blood cells normally help the body to fight infection. Acute lymphoblastic leukaemia is a type of leukaemia in which some abnormal white blood cells (called lymphoblasts) start to grow out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start to grow out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (called eosinophils) start to grow out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal stromal tumours (GISTs). GIST is a cancer of the stomach and intestines. It originates from uncontrolled cell growth of the supporting tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which some cells start to grow out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, these 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, ask your doctor.

2. What you need to know before you take Imatinib Teva

Imatinib Teva will only be prescribed by a doctor with experience in medicines to treat blood cell cancer or solid tumours.

Follow carefully all instructions given to you by your doctor, even if they are different from the general information contained in this leaflet.

Do not take Imatinib Teva

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

If this applies to you, tell your doctor and do not take Imatinib Teva.

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

Warnings and precautions

Tell your doctor before you take Imatinib Teva:

• if you have or have ever had any problems with your liver, kidneys, or heart.
• if you are taking a medicine that contains levothyroxine because you have had your thyroid gland removed.
• if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor should check you carefully for signs of this infection before starting treatment.
• if while taking Imatinib Teva you get bruising, bleeding, fever, fatigue, and confusion, please contact your doctor. This could be a sign of blood vessel damage called thrombotic microangiopathy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may be more sensitive to the sun while taking Imatinib Teva. It is important that you cover the skin that is exposed to the sun and use a sunscreen with high protection. These precautions also apply to children.

Tell your doctor immediately if you gain weight very quickly while taking Imatinib Teva. Imatinib Teva can cause water retention in your body (severe fluid retention).

While taking Imatinib Teva, your doctor will regularly check if 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 and adolescents with CML. There is no experience in children with CML under 2 years of age. Experience in children with Ph+ ALL is limited and experience in children with MDS/MPD, DFSP, GIST, and HES/CEL is very limited.

Some children and adolescents taking Imatinib Teva may grow more slowly than others. The doctor will monitor growth at regular visits.

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 obtained without a prescription (such as paracetamol) and herbal medicines (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 the same effect on other medicines.

Tell your doctor if you are using medicines that prevent blood clots.

Pregnancy, breast-feeding, and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Imatinib Teva is not recommended during pregnancy unless clearly necessary, as it may harm your baby. Your doctor will discuss with you the potential risks of taking Imatinib Teva during pregnancy.
• Women who may become pregnant are advised to use an effective method of contraception during treatment and for 15 days after finishing treatment.
• Do not breast-feed while taking Imatinib Teva and for 15 days after finishing treatment, as it may harm your baby.
• Patients who are concerned about their fertility while taking Imatinib Teva should consult their doctor.

Driving and using machines

You may feel dizzy or drowsy or have blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you feel better.

3. How to take Imatinib Teva

Your doctor has prescribed Imatinib Teva for you because you have a serious illness. Imatinib Teva can help you fight this illness.

However, follow your doctor’s, pharmacist’s, or nurse’s instructions exactly as they tell you. It is also important to take Imatinib Teva for as long as your doctor tells you. If you are not sure about anything, ask your doctor, pharmacist, or nurse.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you cannot take the medicine as your doctor has prescribed or if you think you no longer need it, contact your doctor immediately.

How much to take

Adults

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

• If you are being treated for CML:

The usual starting dose is either 400 mg or 600 mg:

• 400 mg, which is 1 tablet once a day,
• 600 mg, which is 1 tablet of 400 mg plus 2 tablets of 100 mg or 1 and a half 400 mg tablets once a day.

• If you are being treated for GIST:

The starting dose is 400 mg, which is 1 tablet once a day.

For CML 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 (2 tablets), take 1 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, which is 1 tablet of 400 mg plus 2 tablets of 100 mg or 1 and a half 400 mg tablets once a day.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg, which is 1 tablet once a day.

• If you are being treated for HES/CEL:

The starting dose is 100 mg, which is 1 tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, which is 1 tablet of 400 mg once a day, depending on how you respond to treatment.

• If you are being treated for DFSP:

The dose is 800 mg per day (2 tablets), which is 1 tablet in the morning and 1 tablet in the evening.

Children and adolescents

Your doctor will tell you how many Imatinib Teva tablets to give to your child. The amount of Imatinib Teva given will depend on the child’s condition, body weight, and height. The total daily dose in children and adolescents should not exceed 800 mg in CML and 600 mg in Ph+ ALL. Treatment can be given to the child once a day or, alternatively, the dose can be split into two doses (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 you from stomach problems when taking Imatinib Teva.
• Swallow the tablets with a large glass of water.

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

• Use approximately 200 ml for each 400 mg tablet
• Stir with a spoon until the tablet is completely dissolved
• Drink the whole contents of the glass immediately. There may be sediment at the bottom of the glass.

The tablet can be divided into equal doses.

How long to take Imatinib Teva

Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should

If you accidentally take too many tablets, talk to your doctor immediately. You may need medical attention. 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 nearly time for the next dose, do not take the missed 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. These are usually mild to moderate.

Some adverse effects can be serious. Inform your doctor immediately if you suffer from any of the following:

Very Common(may affect more than 1 in 10 patients) or Common(may affect up to 1 in 10 patients):

• 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 ulcers in the mouth. Imatinib Teva may reduce the number of white blood cells in the blood, so you may get infections more easily.
• Bleeding or bruising unexpectedly (when you have not had any injury).

Uncommon(may affect up to 1 in 100 patients) or Rare(may affect up to 1 in 1,000 patients):

• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, with difficulty breathing or painful breathing (signs of lung problems).
• Feeling dizzy, lightheaded, or fainting (signs of low blood pressure).
• Nausea, with loss of appetite, dark-colored urine, yellow skin or eyes (signs of liver problems).
• Rash, skin redness, with blisters on the lips, eyes, skin, or mouth, skin peeling, fever, red or purple skin spots, itching, burning sensation, rash with pus (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools, or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in urine output, feeling thirsty (signs of kidney problems).
• Nausea, with diarrhea and vomiting, abdominal pain, or fever (signs of intestinal problems).
• Severe headache, weakness, or paralysis in the limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Pale skin, feeling tired, and having difficulty breathing, dark-colored urine (signs of low red blood cell count in the blood).
• Pain in the eyes or vision disturbances, bleeding in the eyes.
• Pain in the bones or joints (signs of osteonecrosis).
• Blisters on the skin or mucous membranes (signs of pemphigus).
• Numbness or feeling cold in the feet and toes (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (sign of a skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and muscle spasms, with an abnormal heartbeat (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle spasms with fever, reddish-brown urine, pain, or weakness in the muscles (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 in the ovaries or uterus).
• Nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint discomfort 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).

Frequency Not Known(cannot be estimated from the available data):

• Combination of a widespread rash, feeling unwell, fever, high levels of certain blood cells, or yellow skin or eyes (signs of jaundice) with difficulty breathing, chest pain/discomfort, severely decreased urine production, and feeling thirsty, etc. (signs of an allergic reaction related to treatment)

• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection).

If you experience any of the above alterations, inform your doctor immediately.

Other Adverse Effects May Include:

Very Common(may affect more than 1 in 10 people):

• Headache or feeling tired
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or pain in the joints, muscles, or bones, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as swollen ankles or eyes.
• Weight gain.

If any of these affect you significantly, inform your doctor.

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

• Lack of appetite, weight loss, or altered sense of taste.
• Feeling tired or weak.
• Difficulty sleeping (insomnia).
• Watery eyes with itching, redness, and swelling (conjunctivitis), or tearing, or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, gas, heartburn, or constipation.
• Itching.
• Weakness or unusual hair loss.
• Numbness of the hands or feet.
• Ulcers in the mouth.
• Pain in the joints with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats.

If any of these affect you significantly, consult your doctor.

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

• Cough, secretion, or blockage in the nose, feeling of heaviness or pain when pressing the area around the eyes or to the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache, like a stabbing pain or a 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 urinating, fever, pain in the groin or pelvis, cloudy or reddish-brown 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 disrupts your ability to lead a normal life (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
• Drowsiness/somnolence/excessive sleepiness.
• Tremors or involuntary movements (tremor).
• Memory impairment.
• Need to constantly move the legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching or gas.
• Lip inflammation.
• Difficulty swallowing.
• Increased sweating.
• Discoloration of the skin.
• Brittle nails.
• Reddish spots or pimples around the hair root, possibly with pain, itching, or burning sensation (signs of folliculitis, also called inflamed hair follicles).
• Skin rash with peeling or skin shedding (exfoliative dermatitis).
• Breast growth (can occur in men or women).
• Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain when urinating, having sex, or ejaculating, blood in the urine (signs of testicular edema).
• Difficulty having or maintaining an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving or maintaining sexual excitement.
• Decreased sexual desire.
• Nipple pain.
• General feeling of discomfort (general malaise)
• Viral infections such as cold sores.
• Lower back pain due to a kidney disorder.
• 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, black stools (signs of stomach ulcer).
• Stiffness in the joints or muscles.
• Abnormal laboratory test results.
• Red, painful lumps on the skin, skin pain, skin redness (inflammation of the fatty tissue under the skin).

If any of these affect you significantly, consult your doctor.

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

• Confusion.
• Nail discoloration.

If any of these affect you significantly, consult your doctor.

Frequency Not Known(cannot be estimated from the available data):

• Redness and/or swelling of the palms of the hands and the soles of the feet, which may be accompanied by a tingling sensation and burning pain.
• Painful skin lesions and/or blisters.
• Delayed growth in children and adolescents.

If any of these affect you significantly, consult your doctor.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imatinib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use any packaging if you notice that it is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of packages and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Imatinib Teva

• The active ingredient is imatinib (as mesilate).
• Each Imatinib Teva film-coated tablet contains 400 mg of imatinib (as mesilate).

• The other ingredients are calcium hydrogen phosphate, crospovidone, and magnesium stearate.
• The tablet coating is made of partially hydrolyzed polyvinyl alcohol, macrogol, yellow iron oxide (E172), talc, titanium dioxide (E171), and red iron oxide (E172).

Appearance of the Product and Package Contents

Imatinib Teva 400 mg film-coated tablets are oblong, yellowish-brown to orange-brown film-coated tablets with a score line on one side. The tablet is engraved with "IT" and "4" on either side of the score line. The tablets are approximately 20 mm long and 10 mm wide.

Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.

Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

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

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet {Month/Year}.

Other Sources of Information

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