Imatinib STADA – Imatinib uses, dose and side effects


100 mg film-coated tablet

What Imatinib STADA is and what it is used for

Imatinib Stada 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 Stada is a treatment for adults and children for:

  • Chronic myeloid leukemia (CML) . Leukemia is a cancer of the white blood cells . These white blood cells usually help the body fight infection . Chronic myeloid leukemia is a form of leukemia in which certain abnormal white blood cells (so-called myeloid cells) begin to grow out of control.
  • Philadelphia chromosome-positive acute lymphoblastic leukemia ( Ph- positive ALL) Leukemia is a cancer of the white blood cells . These white blood cells normally help the body fight infection . Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal, immature white blood cells (so-called lymphoblasts ) begin to grow out of control. Imatinib Stada inhibits the growth of these cells.

Imatinib Stada is also a treatment for adults for:

  • Myelodysplastic / myeloproliferative disorders (MDS / MPD) . These are a group of blood diseases in which certain blood cells begin to grow out of control. Imatinib Stada 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 Stada inhibits the growth of these cells in a certain subset of these diseases.
  • Dermatofibrosarcoma protuberans (DFSP) . DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Imatinib Stada 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 Stada works or why this medicine has been prescribed for you.

Imatinib contained in Imatinib Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Imatinib STADA

Do not use Imatinib STADA

  • 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 Stada without telling your doctor.

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Imatinib Stada:

  • 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 Stada can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment
  • if you get bruises, bleeding, fever, get very tired and confused when taking Imatinib Stada, 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 Stada.

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

When you are taking Imatinib Stada, 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 Stada is also a treatment for children with CML. There is no experience from children with CML under 2 years. There is limited experience from children with Ph-positive ALL and very limited experience from children with MDS / MPD, DFSP, and HES / CEL.

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

Other medicines and Imatinib STADA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may affect the effect of Imatinib Stada when taken together. They may increase or decrease the effect of Imatinib Stada and either leads to more side effects or make Imatinib Stada less effective. Imatinib Stada can do the same for 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 breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • Imatinib Stada is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Stada during pregnancy.
  • Women who may become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
  • Do not breast-feed during treatment with Imatinib Stada 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 Stada 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.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Imatinib STADA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free. next to “sodium-free”.

How to use Imatinib STADA

Your doctor has prescribed Imatinib Stada for you to suffer from a serious illness. Imatinib Stada can help you fight this condition.

Always take this medicine exactly as your doctor or pharmacist has told you. You must do this as long as your doctor or pharmacist tells you to. Ask your doctor or pharmacist if you are unsure.

Each time you take a tablet, the purified rayon should be returned to the jar to prevent damage to the film-coated tablets.

How much Imatinib Stada to take

Use for adults

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

If you are being treated for KML:

Depending on your condition, the recommended starting dose is either 400 mg or 600 mg:

  • 400 mg taken as four 100 mg tablets are a once a day.
  • 600 mg taken as six 100 mg tablets a once a day.

For CML, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg, take four 100 mg tablets in the morning and four 100 mg tablets in the evening.

If you are being treated for Ph-positive ALL:

  • The starting dose is 600 mg taken as six 100 mg tablets a once daily.

If you are being treated for MDS / MPD:

  • The starting dose is 400 mg taken as four 100 mg tablets a once daily.

If you are being treated for HES / CEL:

  • The starting dose is 100 mg taken as a 100 mg tablet a once daily. Your doctor may decide to increase the dose of one 400 mg taken as four 100 mg tablets a once daily, depending on how you respond to treatment.

If you are being treated for DFSP:

  • Dose one is 800 mg per day, taken as four 100 mg tablets in the morning and four 100 mg tablets in the evening.

Use for children and adolescents

Your doctor will tell you how many Imatinib Stada tablets to give to your child. The amount of Imatinib Stada given depends on your child’s condition, body weight, and height.

The total dose for children should not exceed 800 mg for CML and 600 mg for Ph-positive ALL. The treatment can either be given to your child as a single dose or 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 Stada

  • Take Imatinib Stada with a meal . It helps to protect against stomach problems when you take Imatinib Stada.
  • Swallow the tablets whole with a large glass of water .

If you can not swallow the tablets, you can slurry them in either a glass of non-carbonated water or apple juice:

  • Take about 50 ml for each 100 mg tablet.
  • Stir with a spoon until the tablets have completely dissolved.
  • Once the tablet has dissolved, immediately drink the entire contents of the glass. Residues of the dissolved tablets may remain in the glass.

How long to take Imatinib Stada

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

If you use more Imatinib STADA 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 have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Imatinib STADA

  • 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 stop using Imatinib STADA

Do not stop taking Imatinib Stada unless your doctor tells you to. If you are unable to take the medicine as prescribed by your doctor or if you feel you no longer need it, contact your doctor immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 user in 10) or common (may affect up to 1 user in 10):

  • Rapid weight gain. Imatinib Stada can cause your body to bind water (severe fluid retention ).
  • Signs of infection , e.g. fever, frostbite, sore throat or sore mouth. Imatinib Stada can reduce the number of white blood cells so that you can get an infection more easily .
  • Sudden bleeding or sores (when you have not injured yourself).

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

  • 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).

Has been reported (occurs in unknown number of users):

  • Combination of severe skin rash, nausea, fever, high levels of certain white blood cells or yellow skin or eyes (signs of jaundice) with shortness of breath, chest pain / discomfort, greatly reduced urine production and feeling of thirst, etc.
  • 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 Stada or after stopping Imatinib Stada.
  • 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):

  • Anorexia , weight loss or taste disturbances.
  • Dizziness or weakness.
  • Sleep problems ( insomnia ).
  • Runny eyes with itching , redness and swelling (conjunctivitis), watery eyes or blurred vision.
  • Nosebleed.
  • Abdominal pain or distended abdomen, flatulence, heartburn, constipation.
  • Itching .
  • Unexpectedly heavy hair loss or thinning of the hair.
  • Numbness in hands and feet.
  • Sores in the mouth.
  • Joint pain with swelling.
  • Dry mouth , dry skin or dry eyes.
  • Decreased or increased sensitivity of the skin.
  • Hot flashes, chills or night sweats.

Tell your doctor if any of these affect you seriously.

Has been reported (occurs in unknown number of users):

  • Redness and / or swelling in the palms and soles of the feet which may be accompanied by a stinging sensation or burning pain.
  • Painful changes in the skin with or without blisters.
  • Slow growth in children and adolescents.

Tell your doctor if any of these affect you seriously.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Imatinib STADA

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, blister or can after EXP. The expiration date is the last day of the specified month.

HDPE can:

Imatinib Stada 100 mg 60 film-coated tablets / can: discarded 180 days after first opening.

Imatinib Stada 100 mg 90 film-coated tablets / can: discarded 135 days after first opening.

Do not store above 25 ° C.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not use if any packaging is damaged or shows signs of having been opened or otherwise handled improperly.

6. Contents of the packaging and other information

Content declaration

The active substance is imatinib.

Each film-coated tablet contains imatinib mesylate equivalent to 100 mg imatinib.

Other ingredients are:

Sodium stearyl fumarate

The tablet coating consists of;

Opadry brown consisting of hydroxypropyl methylcellulose, red iron oxide (E172), yellow iron oxide (E172), talc.

What the medicine looks like and contents of the pack

Imatinib Stada 100 mg film-coated tablets are brownish, round, biconvex, film-coated tablets debossed with “100” on one side and with a score line on the other side, with “N” on one side of the score and “I” on the other side of the score .

Thickness: about 2.9 – 3.5 mm

Diameter: about 6.9 – 7.3 mm

The tablet can be divided into two equal parts.

Imatinib Stada film-coated tablets are supplied in Al / Al blisters or in HDPE cans with child-resistant PP lids with purified rayon inside.

Blisters: 10, 30, 50 (hospital packaging), 60, 90, 100, 120, 150, 180 and 200

HDPE jar with child-resistant PP / PE lid with purified rayon inside: 1 x 60, 1 x 90, 120 (2 x 60), 180 (3 x 60).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel


Other manufacturers


Alba Iulia Street, No 156, 550052 Sibiu, Romania


Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev


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