ИМАТИНИБ 100 мг Фильм-coated таблетки

Содержание инструкции

1. Imatinib Sandoz 100 mg film-coated tablets, 400 mg film-coated tablets
   1. What is Imatinib Sandoz and what is it used for
   2. What you need to know before taking Imatinib Sandoz
   3. How to take Imatinib Sandoz
   4. Possible side effects
   5. How to store Imatinib Sandoz
   6. Package contents and other information

Imatinib Sandoz 100 mg film-coated tablets, 400 mg film-coated tablets

Generic medicine

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

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

Contents of this leaflet:

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

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

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

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

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

Imatinib Sandoz is also indicated in adults for the treatment of:

• Myelodysplastic/Myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which blood cells (called eosinophils) begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells in a certain subtype of these diseases.

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• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the subcutaneous tissue in which some cells begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells.

If you have any questions about how Imatinib Sandoz works or why it has been prescribed for you, ask your
doctor.

2. What you need to know before taking Imatinib Sandoz

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

Do not take Imatinib Sandoz

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

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

Warnings and precautions
Talk to your doctor before taking Imatinib Sandoz.

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

If you are in any of these situations, consult your doctor before taking Imatinib Sandoz.
During treatment with Imatinib Sandoz you may become more sensitive to the sun. It is important to cover areas of
skin exposed to the sun and use a sunscreen with a high sun protection factor (SPF). These
precautions also apply to children.

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

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

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

Pregnancy, breastfeeding and fertility

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

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

3. How to take Imatinib Sandoz

Your doctor has prescribed Imatinib Sandoz because you suffer from a serious condition. Imatinib Sandoz can
help you fight this condition.
However, take this medicine following exactly the instructions of your doctor or pharmacist. It is
important that you do so as long as your doctor or pharmacist tells you. If you have any doubts, consult your doctor or pharmacist.
Do not stop taking Imatinib Sandoz 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 Sandoz to take
Use in adults
Your doctor will tell you exactly how many tablets of Imatinib Sandoz you must take.

• If you are being treated for CML:Depending on your condition, the usual initial dose is 400 mg or 600 mg:
• 400 mg to be taken as 4 tablets oncea day
• 600 mg to be taken as 6 tablets oncea day.
• 400 mg to be taken as 1 tablet oncea day

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• 600 mg to be taken as 1 tablet of 400 mg plus half a tablet of 400 mg (or 2 tablets of 100 mg) once a day.

For CML, your doctor may prescribe a higher or lower dosage depending on how you respond to the
treatment. If the daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4
tablets in the evening. If the daily dose is 800 mg (2 tablets), you should take 1 tablet in the morning and 1
tablet in the evening.

• If you are being treated for Ph+ ALL:The initial dose is 600 mg to be taken as 6 tablets oncea day. The initial dose is 600 mg to be taken as 1 tablet of 400 mg plus half a tablet of 400 mg (or 2 tablets of 100 mg) oncea day.
• If you are being treated for MSD/MPD:The initial dose is 400 mg, to be taken as 4 tablets oncea day. The initial dose is 400 mg, to be taken as 1 tablet oncea day.
• If you are being treated for HES/LEC:The initial dose is 100 mg, to be taken as 1 tablet oncea day. The doctor may decide to increase the dosage to 400 mg, to be taken as 4 tablets oncea day based on your response to treatment. The initial dose is 100 mg, to be taken as 1 tablet of 100 mg oncea day. The doctor may decide to increase the dosage to 400 mg, to be taken as one tablet of 400 mg oncea day 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. The dose is 800 mg per day (2 tablets), to be taken as 1 tablet in the morning and 1 tablet in the evening.

Use in children and adolescents
Your doctor will tell you how many tablets of Imatinib Sandoz to give to your child. The amount of Imatinib Sandoz
administered will depend on the child's condition, weight and height. The total daily dose should not
exceed 800 mg in children with CML and 600 mg in children with Ph+ ALL. Treatment may be
administered 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).

The tablet can be divided into two equal doses.

When and how to take Imatinib Sandoz

• Take Imatinib Sandoz with a meal. This will help you avoid stomach problems when taking Imatinib Sandoz.
• Swallow the tablets whole with a large glass of water.

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

• Use about 50 ml for each 100 mg tablet. Use about 200 ml for each 400 mg tablet or about 100 ml for each half 400 mg tablet.
• Stir with a spoon until the tablets are completely dissolved.

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• Once the tablet has dissolved, drink the entire contents of the glass immediately. Tablet residues dissolved may be left in the glass.

For how long to take Imatinib Sandoz
Continue to take Imatinib Sandoz every day for as long as your doctor tells you.

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

If you forget to take Imatinib Sandoz

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually, side effects are mild to moderate.

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

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

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

• 1,000):
• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, difficulty breathing or painful breathing (signs of lung problems).
• Feeling faint, dizziness or fainting (signs of low blood pressure).
• Feeling unwell (nausea), with loss of appetite, dark urine, yellowing of the skin or eyes (signs of liver problems).
• Skin rash, red skin with blisters on lips, eyes, skin or mouth, peeling skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Significant decrease in the amount of urine, feeling thirsty (signs of kidney problems).
• Feeling unwell (nausea) with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems).

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• Severe headache, weakness or paralysis of the limbs or face, difficulty speaking, sudden loss of consciousness (signs of problems with the nervous system such as bleeding or swelling in the skull/brain).
• Paleness, feeling tired and short of breath, and dark urine (signs of low red blood cell levels).
• Eye pain or worsening vision, bleeding in the eyes.
• Hip pain or difficulty walking.
• Numb or cold toes or fingers (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Hearing problems.
• Muscle weakness and muscle spasms with an abnormal heartbeat (signs of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with feeling unwell (nausea).
• Muscle spasms with fever, reddish-brown urine, muscle pain or weakness (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with the ovaries and uterus).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint disorders associated with abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium and low levels of phosphorus in the blood)
• Blood clots in small blood vessels (thrombotic microangiopathy)

Not known(frequency cannot be estimated from 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) with shortness of breath, chest pain/discomfort, significant decrease in urine production and feeling thirsty, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure
• Reactivation (reactivation) of hepatitis B infection if you have had hepatitis B in the past (a liver infection). If you experience any of the effects described above, tell your doctor immediately.

Other side effects may include:
Very common(may affect more than 1 in 10 people):

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

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

• Loss of appetite, weight loss or altered sense of taste.
• Feeling dizzy or weak.
• Sleep disorders (insomnia).
• Eye discharge with itching, redness and swelling (conjunctivitis), increased tearing or blurred vision.

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• Nosebleeds.
• Abdominal pain or bloating, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth sores.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills or night sweats. If any of these effects occur severely, tell your doctor.Not known(frequency cannot be estimated from available data):
• Redness and/or swelling of the palms of the hands and soles of the feet which may be accompanied by a tingling and burning painful sensation.
• Painful and/or blistering skin lesions
• Slowed growth in children and adolescents. If any of these effects occur severely, tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor,
pharmacist or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Imatinib Sandoz

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 or the box after Exp. The date
of expiry refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Imatinib Sandoz contains

• The active ingredient is imatinib mesylate. Each film-coated tablet contains 100 mg or 400 mg of imatinib (as mesylate).
• The other components of the tablet core are microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate and anhydrous colloidal silica.
• The other components of the tablet coating are red iron oxide (E172), yellow iron oxide (E172), macrogol 4000, talc and hypromellose.

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Description of the appearance of Imatinib Sandoz and package contents
Each film-coated tablet of Imatinib Sandoz, with an approximate diameter of 9.2 millimeters, is
from very dark yellow to brownish-orange in color, round, biconvex with beveled edges, with "NVR"
imprinted on one side and "SA" and a fracture line between the letters on the opposite side.
Each film-coated tablet of Imatinib Sandoz, with an approximate length of 19.2 millimeters and
a thickness of 7.7 mm, is from very dark yellow to brownish-orange in color, ovaloid, biconvex with beveled
edges, with "400" imprinted on one side and a fracture line on the opposite side and “SL” on each side of the
fracture line.
The tablet can be divided into two equal halves.
The tablets are available in PVC/Alu or PVC/PE/PVDC/Alu blisters in packs of 20, 30,
50, 60, 80, 90 or 120 tablets.
The tablets are available in PVC/PE/PVDC/Alu blisters in packs of 10, 30, 50, 60, 80 or 90
tablets.
Not all pack sizes may be marketed.

Marketing authorization holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova ulica 57, 1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D, 9220 Lendava
Slovenia
Novartis Pharma GmbH
Roonstrasse 25, 90429 Nürnberg
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following
denominations:
Austria Imatinib Sandoz 100 mg – Filmtabletten
Imatinib Sandoz 400 mg – Filmtabletten
Belgium Imatinib Sandoz, 100 mg film-coated tablets
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Imatinib Sandoz, 400 mg film-coated tablets
Bulgaria Imatinib Sandoz
Croatia Imatinib Sandoz 100 mg filmom obložene tablete
Imatinib Sandoz 400 mg filmom obložene tablete
Cyprus Imatinib Sandoz 100 mg
Imatinib Sandoz 400 mg
Czech Republic Imatinib Sandoz 100 mg
Imatinib Sandoz 400 mg
Denmark Imatinib Sandoz
Estonia Imatinib Sandoz
Finland Imatinib Sandoz
France Imatinib Sandoz 100 mg, divisible film-coated tablet
Imatinib Sandoz 400 mg, divisible film-coated tablet
Germany Imatinib HEXAL 100 mg Filmtabletten
Imatinib HEXAL 400 mg Filmtabletten
Greece IMATINIB/SANDOZ
Hungary Imatinib Sandoz 100 mg filmtabletta
Imatinib Sandoz 400 mg filmtabletta
Ireland Imatinib Rowex 100 mg Film-coated tablets
Imatinib Rowex 400 mg Film-coated tablets
Italy Imatinib Sandoz
Latvia Imatinib Sandoz 100 mg apvalkotās tabletes
Imatinib Sandoz 400 mg apvalkotās tabletes
Lithuania Imatinib Sandoz 100 mg plėvele dengtos tabletės
Imatinib Sandoz 400 mg plėvele dengtos tabletės
Luxembourg Imatinib Sandoz 100 mg comprimés pelliculés
Imatinib Sandoz 400 mg comprimés pelliculés
Netherlands Imatinib Sandoz 100 mg, filmomhulde tabletten
Imatinib Sandoz 400 mg, filmomhulde tabletten
Norway Imatinib Sandoz
Poland Imatinib Sandoz
Portugal Imatinib Sandoz
Romania Imatinib Sandoz 100 mg comprimate filmate
Imatinib Sandoz 400 mg comprimate filmate
Slovakia Imatinib Sandoz 100 mg
Imatinib Sandoz 400 mg
Slovenia Imatinib Lek 100 mg filmsko obložene tablete
Imatinib Lek 400 mg filmsko obložene tablete
Spain Imatinib Sandoz 100 mg film-coated tablets EFG
Imatinib Sandoz 400 mg film-coated tablets EFG
Sweden Imatinib Sandoz
United Kingdom Imatinib 100 mg film-coated tablets
Imatinib 400 mg film-coated tablets
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