ИМАТИНИБ 100 мг Капсулы

Содержание инструкции

1. Imatinib Dr. Reddy’s 100 mg hard capsules
   1. What is Imatinib Dr. Reddy’s and what is it used for
   2. What you need to know before taking Imatinib Dr. Reddy’s
   3. How to take Imatinib Dr. Reddy’s
   4. Possible side effects
   5. How to store Imatinib Dr. Reddy’s
   6. Package contents and other information

Imatinib Dr. Reddy’s 100 mg hard capsules

Generic medicine

Read this leaflet carefully before 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 may 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 Dr. Reddy’s is and what it is used for
• 2. What you need to know before you take Imatinib Dr. Reddy’s
• 3. How to take Imatinib Dr. Reddy’s
• 4. Possible side effects
• 5. How to store Imatinib Dr. Reddy’s
• 6. Contents of the pack and other information

1. What is Imatinib Dr. Reddy’s and what is it used for

Imatinib Dr. Reddy’s 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 Dr. Reddy’s is a treatment indicated in adults and children for:

• Chronic myeloid leukemia (CML).Leukemia is a cancer of the white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukemia is a form 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 the white blood cells. White blood cells normally help
the body fight infections. Acute lymphoblastic leukemia is a form of
leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to
grow uncontrollably. Imatinib Dr. Reddy’s inhibits the growth of these cells.

Imatinib Dr. Reddy’s is also indicated in adult patients for the treatment of:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD).These are a group of blood diseases in which some blood cells begin to grow uncontrollably. Imatinib Dr. Reddy’s inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL).These are blood diseases where some blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Dr. Reddy’s inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal stromal tumors (GIST).GIST is a cancer of the stomach and intestine. It originates from the uncontrolled growth of cells that support the tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP).DFSP is a tumor of the subcutaneous tissue in which some cells begin to grow uncontrollably. Imatinib Dr. Reddy’s inhibits the growth of these cells.

diseases.
If you have any questions about how Imatinib Dr. Reddy’s works or why it has been
prescribed to you, consult your doctor.

2. What you need to know before taking Imatinib Dr. Reddy’s

Imatinib Dr. Reddy’s will only be prescribed by doctors with experience in medicines for the
treatment of blood cancers and solid tumors.
Follow your doctor's instructions carefully, even if they differ from the
general information contained in this leaflet.

Do not take Imatinib Dr. Reddy’s:

• 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 Dr. Reddy’s.

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 Dr. Reddy’s:

• if you have or have had liver or kidney problems or heart problems.
• if you are taking the medicine levothyroxine because your thyroid has been removed.
• if you have ever had or may currently have a hepatitis B infection. This is because Imatinib Dr. Reddy’s 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 are in any of these situations, consult your doctor before taking Imatinib Dr.
Reddy’s.
During treatment with Imatinib Dr. Reddy’s, immediately inform your doctorif
you gain weight very quickly. Imatinib Dr. Reddy’s can cause your body to retain
water (severe fluid retention).
While you are taking Imatinib Dr. Reddy’s, your doctor will need to regularly check if the
medicine is effective. You will also have blood tests and be weighed regularly.

Children and adolescents
Imatinib Dr. Reddy’s is also a treatment for children with LCM. There is no experience in
children with LCM under 2 years of age. There is limited experience in children with ALL
Ph+ and very limited experience in children and adolescents with MDS/MPD, DFSP, GIST and
HES/LEC.
Some children and adolescents taking Imatinib Dr. Reddy’s may experience slower growth than normal. The doctor will check growth at regular intervals.

Other medicines and Imatinib Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available 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 Dr. Reddy’s when taken together.
They can increase or decrease the effect of Imatinib Dr. Reddy’s, leading to an increase
in side effects or making Imatinib Dr. Reddy’s less effective. Imatinib Dr.
Reddy’s can do the same for other medicines.
Tell your doctor if you are using other medicines that prevent blood clots from forming.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
• Imatinib Dr. Reddy’s 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 Dr. Reddy’s during pregnancy with you.
• Women who could become pregnant are advised to use effective contraception during treatment.
• Do not breastfeed during treatment with Imatinib Dr. Reddy’s.
• Patients who are concerned about their fertility during treatment with Imatinib Dr. Reddy’s 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 and do not use tools or machinery until you feel
well again.

3. How to take Imatinib Dr. Reddy’s

Your doctor has prescribed Imatinib Dr. Reddy’s because you suffer from a serious condition.
Imatinib Dr. Reddy’s 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 this until your doctor or pharmacist tells you otherwise. If you have
any doubts, consult your doctor or pharmacist.
Do not stop taking Imatinib Dr. Reddy’s 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.

How much Imatinib Dr. Reddy’s to take
Use in adults
Your doctor will tell you exactly how many capsules of Imatinib Dr. Reddy’s to take.

If you are being treated for CML:
Depending on your condition, the usual starting dose is 400 mg or 600 mg:

• 400 mg to be taken, for example, as 1 capsule of 400 once a day
• 600 mg to be taken, for example, as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.

If you are being treated for GIST:
The starting dose is 400 mg to be taken as 8 capsules oncea day.
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, you should take half the dose (e.g. 1
capsule of 400 mg) in the morning and half the dose (e.g. 1 capsule of 400 mg) in the evening.

• If you are being treated for Ph+ ALL:

The starting dose is 600 mg to be taken as, for example, 1 capsule of 400 mg plus 2 capsules
of 100 mg oncea day.

• If you are being treated for MDS/MPD:

The starting dose is 400 mg to be taken as, for example, 1 capsule of 400 mg oncea
day.

• If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as, for example, 1 capsule of 100 mg oncea
day. Your doctor may decide to increase the dosage to 400 mg to be taken as, for
example, 1 capsule 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, to be taken as half the dose (e.g. 1 capsule of 400
mg) in the morning and half the dose (e.g. 1 capsule of 400 mg) in the evening.

Use in children and adolescents
Your doctor will tell you how many capsules of Imatinib Dr. Reddy’s should be given to the child. The
amount of Imatinib Dr. Reddy’s given 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 can be given to the child as a single daily dose or, alternatively, the dose can be divided into two administrations (half
in the morning and half in the evening).

When and how to take Imatinib Dr. Reddy’s

• Take Imatinib Dr. Reddy’s with a meal.This will help protect your stomach when you take Imatinib Dr. Reddy’s.
• Swallow the tablets whole with a glass of plenty of water.Do not open or break the capsules unless you have difficulty swallowing them (e.g. in children).
• If you are unable to swallow the capsules, you can open them and pour the powder into a glass of still water or apple juice.
• If you are pregnant or might become pregnant and are trying to open the capsules, you should handle the contents with caution to avoid contact with skin and eyes and inhalation. You should wash your hands immediately after opening the capsules.

For how long to take Imatinib Dr. Reddy’s
Continue to take Imatinib Dr. Reddy’s every day for as long as your doctor tells you to.

If you take more Imatinib Dr. Reddy’s than you should
If you have accidentally taken too many capsules, contact your doctor immediately. You may
need medical attention. Bring the medicine packaging with you.

If you forget to take Imatinib Dr. Reddy’s

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

If you have any questions 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. These are generally 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 Dr. Reddy’s can cause your body to retain water (severe fluid retention).

Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Imatinib Dr. Reddy’s can reduce the number of white blood cells, so 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, dizzy or lightheaded (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 the 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 urine output, feeling thirsty (signs of kidney problems).

Feeling unwell (nausea) with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems).

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 of the skull/brain).

Paleness, feeling tired and short of breath, and dark urine (signs of low red blood cell counts).

Eye pain or worsening vision, bleeding in the eyes.

Hip pain or difficulty walking.

Fingers and toes become numb or cold (signs of Raynaud's syndrome).

Sudden swelling or 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 (lividi).

Stomach pain with feeling unwell (nausea).

Muscle spasms with fever, reddish-brown urine, pain or muscle 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 or 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).

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 renal failure.

Recurrence (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), vomiting, diarrhea or indigestion.

Skin rash.

Muscle cramps or joint pain or bone pain.

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 taste disturbances.

Feeling dizzy or weak.

Sleep disorders (insomnia).

Eye discharge with itching, redness and swelling (conjunctivitis), increased tearing or blurred vision.

Nosebleeds.

Abdominal pain or bloating, flatulence, heartburn or constipation.

Itching.

Unusual hair loss or thinning.

Numbness of the hands or feet

Mouth ulcers.

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 defined on the basis of 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.

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
at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imatinib Dr. Reddy’s

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 pack.

Do not store at a temperature above 30°C.

Store in the original package to protect the medicine from moisture.

Do not use if the package is damaged or shows signs of
tampering.

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 to
protect the environment.

6. Package contents and other information

What Imatinib Dr. Reddy’s contains

• The active ingredient is imatinib mesylate. Each Imatinib Dr. Reddy’s capsule contains 100 mg of imatinib (as mesylate).
• The other ingredients are sodium stearyl fumarate and crospovidone (Type A). The capsule shell consists of gelatin, sodium lauryl sulfate, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172). The printing ink consists of red iron oxide (E172), shellac, propylene glycol and concentrated ammonia solution.

Description of the appearance of Imatinib Dr. Reddy’s and package contents
Imatinib Dr. Reddy’s 100 mg capsules are orange to orange-greyish in colour
with the inscription in red ink “RDY” on the upper part of the capsule and “100” on the body
of the capsule and contain a granular powder ranging in colour from off-white to brownish-yellow.
They are supplied in packs of 24, 30, 48, 60, 96, 120 and 180 capsules, but not all
pack sizes may be available in the country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DR. REDDY’S S.r.l. , Piazza S. Maria Beltrade, 1, 20123 Milano,
Italy (IT).

Manufacturer
Dr. Reddy´s Laboratories (UK) Ltd
6, Riverview Road, Beverley, HU 17 0LD, United Kingdom
betapharm Arzneimittel GmbH
Kobelweg 95, Augsburg, 86156, Germany

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Germany Imatinib beta 50 mg/100 mg/400 mg hard capsules
Romania Imatinib Dr. Reddy's 100 mg/400 mg capsules
United Kingdom Imatinib Dr. Reddy's 50 mg/100 mg/400 mg Capsules, Hard
France IMATINIB DR. REDDY’S 100 mg/400 mg capsule
Spain Imatinib Dr. Reddy’s 100 mg/400 mg hard capsules EFG
Italy Imatinib Dr. Reddys, 100 mg