100 mg film-coated tablets
imatinib
What Imatinib Teva is and what it is used for
Imatinib Teva is a medicine that contains an active substance called imatinib. The drug acts by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.
Imatinib Teva is a treatment for adults and children for:
- Chronic myeloid leukemia (CML) . Leukemia is a cancer of the white blood cells . These white blood cells usually help the body fight infection . Chronic myeloid leukemia is a form of leukemia in which certain abnormal white blood cells (so-called myeloid cells) begin to grow out of control.
- Philadelphia chromosome-positive acute lymphoblastic leukemia ( Ph- positive ALL). Leukemia is a cancer of the white blood cells . These white blood cells normally help your body fight infection . Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal, immature white blood cells (so-called lymphoblasts ) begin to grow out of control. Imatinib Teva inhibits the growth of these cells.
Imatinib Teva is also an adult treatment for:
- Myelodysplastic / myeloproliferative disorders (MDS / MPD). These are a group of blood diseases in which certain blood cells begin to grow out of control. Imatinib Teva inhibits the growth of these cells in a certain subset of these diseases.
- Hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukemia (CEL). These are blood diseases in which certain blood cells (so-called eosinophils ) begin to grow out of control. Imatinib Teva inhibits the growth of these cells in a certain subset of these diseases.
- Dermatofibrosarcoma protuberance (DFSP). DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Imatinib Teva inhibits the growth of these cells.
In the rest of this leaflet, abbreviations will be used when talking about these diseases.
Ask your doctor if you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you.
What you need to know before taking Imatinib Teva
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, do not take Imatinib Teva without telling your doctor.
If you think you may be allergic but are not sure, ask your doctor for further advice.
Imatinib Teva will only be prescribed to you by a doctor with medical experience in treating blood cancer or solid tumors.
Follow all of your doctor’s instructions carefully, although these may differ from the general information in this leaflet.
Warnings and cautions
Talk to your doctor before taking Imatinib Teva:
- if you have or have had a liver, kidney or heart disease.
- if you are taking the medicine levothyroxine due to that your thyroid gland has been removed.
- if you have ever had or may have a hepatitis B infection . The reason for this is that Imatinib Teva can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their physician for signs of this infection before starting treatment.
- If you get bruises, bleeding, fever, get very tired and confused while taking Imatinib Teva, contact your doctor. This may be a sign of a damage to the blood vessels called thrombotic microangiopathy (TMA).
If any of these apply to you, tell your doctor before taking Imatinib Teva.
You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover exposed areas of the skin and use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.
When taking Imatinib Teva, tell your doctor immediately if you gain weight quickly. Imatinib Teva may cause your body to bind fluid (severe fluid retention ).
When you take Imatinib Teva, your doctor will regularly check that the medicine is working. You will also be given blood samples and weighed regularly.
Children and young people
Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience from children with CML under 2 years. There is limited experience from children with Ph-positive ALL and very limited experience from children with MDS / MPD, DFSP, and HES / CEL.
Some children and adolescents taking Imatinib Teva may grow more slowly than usual. The doctor will regularly check the growth.
Other medicines and Imatinib Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (eg paracetamol ) and herbal medicines (eg St. John’s wort ). Some medicines may affect the way Imatinib Teva works when taken together. They may increase or decrease the effect of Imatinib Teva and either leads to more side effects or make Imatinib Teva less effective. Imatinib Teva may do the same with some other medicines.
Tell your doctor if you are taking medicines that prevent the formation of blood clots.
Pregnancy, breastfeeding and fertility
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Imatinib Teva is not recommended during pregnancy unless clearly necessary, as it may harm your baby. Your doctor will discuss the possible 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 stopping treatment.
- Do not breast-feed during treatment with Imatinib Teva and for 15 days after stopping treatment as it may be harmful to your baby.
- Patients who are concerned about their fertility when taking Imatinib Teva are advised to consult their doctor.
Driving and using machines
You may feel dizzy or tired or have blurred vision when using this medicine. If this happens, do not drive or use any tools or machines until you feel well again.
How to take Imatinib Teva
Your doctor has prescribed Imatinib Teva because you are suffering from a serious illness. Imatinib Teva can help you fight this disease.
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist, or nurse tells you to. If you are not sure, talk to your doctor, pharmacist, or nurse.
Do not stop taking Imatinib Teva unless your doctor tells you to. If you can not take the medicine according to your doctor’s prescription or if you feel that you do not need it anymore, contact your doctor immediately.
How much Imatinib Teva to take?
Use for adults
Your doctor will tell you exactly how many Imatinib Teva tablets to take.
- If you are being treated for KML:Depending on your condition, the usual starting dose is either 400 mg or 600 mg:- 400 mg to be taken as 4 tablets a once a day,- 600 mg to be taken as 6 tablets a once a day.
Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.
- If you are being treated for Ph -positive ALL:starting dose is 600 mg taken as 6 tablets a once daily.
- If you are being treated for MDS / MPD:starting dose is 400 mg taken as 4 tablets a once daily.
- If you are being treated for HES / CEL:starting dose is 100 mg taken as 1 tablet a once daily. Your doctor may decide to increase the dose of one 400 mg to be taken as 4 tablets a once daily, depending on how you respond to treatment.
- If you are being treated for DFSP:The dose is 800 mg per day (8 tablets) taken as 4 tablets in the morning and 4 tablets in the evening.
Use for children and adolescents
Your doctor will tell you how many Imatinib Teva tablets to give to your child. The amount of Imatinib Teva given depends on your baby’s condition, body weight, and height. The total dose one for children and adolescents should not exceed 800 mg for CML and 600 mg for Ph-positive ALL. The treatment can either be given to your child as a dose once a day or alternatively the daily dose can be given on two different occasions (half in the morning and a half in the evening).
When and how to take Imatinib Teva?
- Take Imatinib Teva with a meal. It helps to protect against stomach problems when you take Imatinib Teva.
- Swallow the tablets whole with a large glass of water.
If you can not swallow the tablets, you can dissolve them in a glass of non-carbonated water or apple juice:
- Use approximately 50 ml for each 100 mg tablet.
- Stir with a spoon until the tablets have completely dissolved.
- Once the tablet has dissolved, drink the entire contents immediately. Traces of the dissolved tablets may remain in the glass.
The tablet can be divided into two equal doses.
How long to take Imatinib Teva?
Continue to take Imatinib Teva every day for as long as your doctor tells you to.
If you take more Imatinib Teva than you should
Contact your doctor immediately if you have accidentally taken too many tablets. You may need medical attention. Take the medicine pack with you.
If you forget to take Imatinib Teva
- If you forget to take a dose , take it as soon as you remember. However, skip the missed dose if it is soon time to take the next dose .
- Then continue with your normal schedule.
- Do not take a double dose to make up for a forgotten dose .
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually of mild to moderate severity.
Some side effects can be serious. Tell your doctor immediately if you get any of the following:
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
- Rapid weight gain. Imatinib Teva can make your body bind water (severe fluid retention ).
- Signs of infection , e.g. fever, frostbite, sore throat or sore mouth. Imatinib Teva can reduce the number of white blood cells so that you can get infected more easily .
- Sudden bleeding or sores (when you have not injured yourself).
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
- Chest pain, irregular heartbeat (signs of heart problems).
- Cough, difficulty breathing or painful breathing (signs of lung problems).
- Feeling dizzy, dizzy or fainting (signs of low blood pressure ).
- Nausea, with decreased appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
- Skin rash, redness with blisters on the lips, eyes, skin or mouth, flaking of the skin, fever, raised red or purple skin areas, itching , burning sensation, rash with small blisters (signs of skin problems).
- Severe abdominal pain, blood in vomit, stool or urine, black stools (signs of gastrointestinal disease).
- Severe urinary incontinence, thirst (signs of kidney problems).
- Nausea, with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems).
- Severe headache, weakness or paralysis of the legs or face, difficulty speaking, sudden unconsciousness (signs of nervous system problems such as bleeding or swelling of the skull / brain).
- Paleness, fatigue and shortness of breath with dark urine (signs of low level of red blood cells ).
- Eye pain or impaired vision, bleeding in the eyes.
- Pain in the hips or difficulty walking.
- Numb or cold toes and fingers (signs of Raynaud’s syndrome).
- Sudden swelling and redness of the skin (signs of a skin infection called cellulite ).
- Impaired hearing.
- Muscle weakness and muscle cramps with abnormal heart rhythm (signs that indicate changes in the amount of potassium in your blood).
- Tendency to get bruises.
- Stomach pain, with nausea.
- Muscle cramps, with fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
- Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, dizziness or fainting due to low blood pressure (signs of ovarian or uterine problems).
- Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and / or joint problems associated with abnormal laboratory values (eg high potassium , uric acid and calcium levels, as well as low phosphorus levels in the blood).
- Blood clots in small blood vessels (thrombotic microangiopathy).
No known frequency (frequency can not be calculated from available data):
- Combination of severe skin rash, nausea, fever, high levels of certain white blood cells or yellow skin or eyes (signs of jaundice) with shortness of breath, chest pain / discomfort, greatly reduced urine production and feeling of thirst, etc. (signs of treatment- related allergic reaction ).
- Chronic renal failure .
- Recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).
Tell your doctor immediately if you get any of the above.
Other side effects may include:
Very common (may affect more than 1 in 10 people):
- Headache or fatigue.
- Nausea, vomiting, diarrhea or indigestion.
- Rash.
- Muscle cramps or pain in joints, muscles or bones during treatment with Imatinib Teva or after stopping Imatinib Teva.
- Swelling around joints or swollen eyes.
- Weight gain.
Tell your doctor if any of these affect you seriously.
Common (may affect up to 1 in 10 people):
- Decreased appetite, weight loss or taste disorders.
- Dizziness or weakness.
- Sleep problems ( insomnia ).
- Runny eyes with itching , redness and swelling (conjunctivitis), watery eyes or blurred vision.
- Nosebleed.
- Abdominal pain or distended abdomen, flatulence, heartburn, constipation.
- Itching .
- Unexpectedly heavy hair loss or thinning of the hair.
- Numbness in hands and feet.
- Sores in the mouth.
- Joint pain with swelling.
- Dry mouth , dry skin or dry eyes.
- Decreased or increased sensitivity of the skin.
- Hot flashes, chills or night sweats.
Tell your doctor if any of these affect you seriously.
No known frequency (frequency can not be calculated from available data):
- Redness and / or swelling in the palms and soles of the feet which may be accompanied by a stinging sensation or burning pain.
- Painful changes in the skin with or without blisters.
- Slow growth in children and adolescents.
Tell your doctor if any of these affect you seriously.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store 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 blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use if any packaging is damaged or shows signs of having been opened or otherwise handled improperly.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
6. Contents of the packaging and other information
Content declaration
- The active substance is imatinib mesylate.
- Each Imatinib Teva film-coated tablet contains 100 mg imatinib (as mesylate).
- 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).
What the medicine looks like and contents of the pack
Imatinib Teva 100 mg film-coated tablets are dark yellow to brown-orange round film-coated tablets with a scoreline on one side. The tablets are marked with “IT” and “1” on each side of the breaker notch. The tablets are approximately 9 mm in diameter.
Imatinib Teva 100 mg film-coated tablets are supplied in packs containing 60 or 120 film-coated tablets in blister packs.
Imatinib Teva 100 mg film-coated tablets are supplied in packs containing 20×1, 60×1, 120×1, or 180×1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva BV
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Teva Czech Industries sro
Ostravska 29, cp 305
74770 Opava-Komarov
Czech Republic
TEVA PHARMA, SLU
C / C, No. 4, Poligono Industrial Malpica
50016 Zaragoza
Spain
Merckle GmbH
Graf-Arco-Str. 3, 89079 Ulm
Germany
Teva Operations Poland Sp. z oo
ul. Mogilska 80, 31-546 Krakow
Poland
Teva Pharma BV
Swensweg 5,
2031 GA Haarlem
Netherlands
PLIVA Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 38207373 | LithuaniaUAB Teva BalticsTel: +370 52660203 |
| BulgariaActavis FADTel: +359 24899585 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG Belgique / BelgienTel: +32 38207373 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 | HungaryTeva Gyógyszergyár Zrt.Tel: +36 12886400 |
| DenmarkTeva Denmark A / STel: +45 44985511 | MaltaTeva Pharmaceuticals IrelandIrelandTel: +353 19127700 |
| GermanyA b Z -Pharma GmbHTel: +49 73140205 | The NetherlandsTeva Nederland BVTel: +31 8000228400 |
| EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 | NorwayTeva Norway ASTel: +47 66775590 |
| GreeceSpecify ABEE:Ηλ: +30 2118805000 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070 |
| SpainTeva Pharma, SLUTel: +34 913873280 | PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300 |
| FranceTeva HealthTel: +33 155917800 | PortugalTeva Pharma – Pharmaceutical Products, Lda.Tel: +351 214767550 |
| CroatiaPliva Hrvatska dooTel: +385 13720000 | RomaniaTeva Pharmaceuticals SRLTel: +40 212306524 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 19127700 | SloveniaPliva Ljubljana dooTel: +386 15890390 |
| IcelandTeva Finland OyFinlandPhone: +358 201805900 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911 |
| ItalyTeva Italia SrlTel: +39 028917981 | Finland / FinlandTeva Finland OyPuh / Tel: +358 201805900 |
| ΚύπροςSpecify ABEEGreece:Ηλ: +30 2118805000 | SwedenTeva Sweden ABTel: +46 42121100 |
| LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 | United KingdomTeva UK LimitedTel: +44 1977628500 |