Imatinib Dr. Reddy's

Italy
Brand name Imatinib Dr. Reddy's
Form capsules, hard gelatin
Active substance / Dosage
IMATINIB MESYLATE
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
L01EA01
Registration number 045053
Manufacturer DR. REDDY'S S.R.L.
Imatinib Dr. Reddy's capsules, hard gelatin

Table of Contents

Package leaflet: Information for the user

Imatinib Dr. Reddy’s 100 mg hard capsules

Generic medicine
Please 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.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
  • If you experience any side effect, including 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 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. Contents of the pack and other information

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

Imatinib Dr. Reddy’s is a medicine containing an active substance called imatinib. In the
conditions listed below, this medicine works by inhibiting the growth of abnormal cells. These
include certain types of cancer.
Imatinib Dr. Reddy’s is a treatment indicated in adults and children for:

  • Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. White blood cells normally help the body fight infections. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to grow uncontrollably.
  • Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL).

Leukaemia is a cancer of white blood cells. White blood cells normally help the body fight
infections. Acute lymphoblastic leukaemia is a type of leukaemia 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 disorders in which certain 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 leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to grow uncontrollably. Imatinib Dr. Reddy’s inhibits the growth of these cells in a specific subtype of these diseases.
  • Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and intestine. It arises from uncontrolled growth of cells that support the tissues of these organs.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of subcutaneous tissue in which certain cells begin to grow uncontrollably. Imatinib Dr. Reddy’s inhibits the growth of these cells.

In the remainder of this patient information leaflet, abbreviations will be used when referring to these
conditions.
If you have any questions about how Imatinib Dr. Reddy’s works or why this medicine has been
prescribed for you, consult your doctor.

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

Imatinib Dr. Reddy’s will only be prescribed by doctors experienced in medicines for the treatment of blood cancers and solid tumours.
Carefully follow all instructions from your doctor, 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 applies to you, consult your doctor before taking Imatinib Dr. Reddy’s.

If you think you might be allergic but are unsure, 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 gland has been removed.
  • if you have ever had or may currently have hepatitis B infection. This is because Imatinib Dr. Reddy’s could cause reactivation of hepatitis B, 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 are in any of these situations, consult your doctor before taking Imatinib Dr. Reddy’s.
During treatment with Imatinib Dr. Reddy’s, inform your doctor immediately if you experience rapid weight gain. Imatinib Dr. Reddy’s may cause your body to retain fluid (severe fluid retention).
While taking Imatinib Dr. Reddy’s, your doctor will need to regularly monitor whether the medicine is working. You will also have regular blood tests and your weight will be checked regularly.
Children and adolescents
Imatinib Dr. Reddy’s is also a treatment for children with CML. There is no experience in children with CML under 2 years of age. Experience is limited in children with Ph+ ALL and very limited in children and adolescents with MDS/MPD, DFSP, GIST, and HES/LEC.
Some children and adolescents taking Imatinib Dr. Reddy’s may have slower than normal growth. Your doctor will monitor 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 without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s wort). Some medicines may interfere with the effect of Imatinib Dr. Reddy’s when taken together.
They may increase or decrease the effect of Imatinib Dr. Reddy’s, leading to more side effects or making Imatinib Dr. Reddy’s less effective. Imatinib Dr. Reddy’s may have the same effect on other medicines.
Inform your doctor if you are taking other medicines that prevent blood clots from forming.
Pregnancy, breastfeeding and fertility

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

Driving and using machines
You may experience dizziness, drowsiness, or blurred vision while taking this medicine. If this occurs, do not drive or operate 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 exactly as instructed by your doctor or pharmacist. It is important to follow these instructions 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 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 taken, for example, as one 400 mg capsule once daily
    • 600 mg taken, for example, as one 400 mg capsule plus two 100 mg capsules once daily.

  • If you are being treated for GIST:
    The starting dose is 400 mg taken as eight capsules once daily.
    For both CML and GIST, your doctor may prescribe a higher or lower dose depending on your response to treatment. If your daily dose is 800 mg, you must take half the dose (e.g., one 400 mg capsule) in the morning and the other half (e.g., one 400 mg capsule) in the evening.

  • If you are being treated for Ph+ ALL:
    The starting dose is 600 mg taken, for example, as one 400 mg capsule plus two 100 mg capsules once daily.

  • If you are being treated for MDS/MPD:
    The starting dose is 400 mg taken, for example, as one 400 mg capsule once daily.

  • If you are being treated for HES/CEL:
    The starting dose is 100 mg, taken, for example, as one 100 mg capsule once daily. Your doctor may decide to increase the dose to 400 mg taken, for example, as one 400 mg capsule once daily, based on your response to treatment.

  • If you are being treated for DFSP:
    The dose is 800 mg per day, taken as half the dose (e.g., one 400 mg capsule) in the morning and half the dose (e.g., one 400 mg capsule) 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 administered will depend on the child's condition, weight, and height. The total daily dose must not exceed 800 mg in children with CML and 600 mg in children with Ph+ ALL. The treatment may be given to the child as a single daily dose or, alternatively, the dose may 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 food. This will help protect your stomach when taking Imatinib Dr. Reddy’s.
  • Swallow the capsules 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 may open them and pour the powder into a glass of still water or apple juice.
  • If you are pregnant or could become pregnant and need to open the capsules, handle the contents with care to avoid skin or eye contact and inhalation. Wash your hands immediately after opening the capsules.

How long to take Imatinib Dr. Reddy’s
Continue taking 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 pack with you.

If you forget to take Imatinib Dr. Reddy’s

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These are generally mild to moderate.
Some side effects may be serious. Contact your doctor immediately if you experience 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 Dr. Reddy’s may cause your body to retain fluid (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat, or mouth ulcers.
Imatinib Dr. Reddy’s may reduce the number of white blood cells, so you may get infections more easily.
Unexpected bleeding or bruising (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 faint, dizzy, or fainting (signs of low blood pressure).
Feeling unwell (nausea), with loss of appetite, dark-coloured urine, yellowing of the skin or eyes (signs of liver problems).
Skin rash, red skin with blisters on the lips, eyes, skin, or mouth, skin peeling, 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).
Marked decrease in urine output, feeling thirsty (signs of kidney problems).
Feeling unwell (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of intestinal problems).
Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling of the brain/skull).
Pale appearance, feeling tired and breathless, dark-coloured urine (signs of low red blood cell levels).
Eye pain or worsening vision, bleeding in the eyes.
Hip pain or difficulty walking.
Numbness or coldness in fingers or toes (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 blood potassium levels).
Bruising (contusions).
Stomach pain with feeling unwell (nausea).
Muscle cramps with fever, red-brown urine, muscle pain or weakness (signs of muscle problems).
Pelvic pain sometimes with nausea and vomiting, unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with ovaries or uterus).
Nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness and/or joint problems associated with abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium, low levels of phosphorus in the blood).
Not known (frequency cannot be estimated from the available data):
Combination of 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, marked decrease in urine production and feeling thirsty, etc. (signs of an allergic reaction related to treatment).

  • Chronic renal failure.

Reactivation (recurrence) of hepatitis B infection if you have previously had hepatitis B (a liver infection).
If you experience any of the above effects, contact 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, diarrhoea or indigestion.
Skin rash.
Muscle cramps or joint pain or bone pain.
Swelling, for example around the ankles or puffy eyes.
Weight gain.
If any of these effects become severe, contact 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 swelling, flatulence, heartburn or constipation.
Itching.
Unusual hair loss or thinning.
Numbness in hands or feet.
Mouth ulcers.
Joint pain with swelling.
Dry mouth, dry skin or dry eyes.
Reduced or increased skin sensitivity.
Hot flushes, chills or night sweats.
If any of these effects become severe, contact your doctor.
Not known (frequency cannot be estimated from the available data):
Redness and/or swelling of the palms of the hands and soles of the feet, which may be accompanied by tingling and painful burning.
Slowed growth in children and adolescents.
If any of these effects become severe, contact your doctor.
Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
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 stated on the carton.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not use if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via 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 Dr. Reddy’s contains

  • The active substance is imatinib mesilate. Each capsule of Imatinib Dr. Reddy’s contains 100 mg of imatinib (as mesilate).
  • The other components are sodium stearil fumarate and crospovidone (Type A). The capsule shell is composed 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 contents of the pack
Imatinib Dr. Reddy’s 100 mg capsules are orange to greyish-orange in colour,
with the imprint in red ink reading “RDY” on the top of the capsule and “100” on the body
of the capsule, and contain a granular powder ranging from off-white to brownish-yellow.
They are supplied in packs of 24, 30, 48, 60, 96, 120 and 180 capsules, although 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 Milan,
Italy (IT).

Manufacturer
Dr. Reddy´s Laboratories (UK) Ltd
6, Riverview Road, Beverley, HU17 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 under the following names:
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 gélule
Spain Imatinib Dr. Reddy’s 100 mg/400 mg cápsulas duras EFG
Italy Imatinib Dr. Reddys, 100 mg