Imatinib EG Stada

Italy
Brand name Imatinib EG Stada
Form tablets, film-coated
Active substance / Dosage
IMATINIB MESYLATE
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
L01EA01
Registration number 051026
Manufacturer EG S.P.A.
Imatinib EG Stada tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Imatinib EG STADA 100 mg film-coated tablets, 400 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further 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, because it may be harmful to them.
  • If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1 What Imatinib EG STADA is and what it is used for
Imatinib EG STADA 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 EG STADA is indicated in adult and paediatric patients for the treatment of:

  • 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 form 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 form of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to grow uncontrollably. Imatinib EG STADA inhibits the growth of these cells.

Imatinib EG STADA is also indicated in adult patients for the treatment of:

  • Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of haematological diseases in which certain blood cells begin to grow uncontrollably. Imatinib EG STADA 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 EG STADA inhibits the growth of these cells in a specific subtype of these diseases.
  • Gastrointestinal stromal tumours (GIST). GIST is a tumour of the stomach and intestine. It arises from uncontrolled growth of cells supporting the tissues of these organs.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the subcutaneous tissue in which certain cells begin to grow uncontrollably. Imatinib EG STADA inhibits the growth of these cells.

In the remainder of this leaflet, abbreviations will be used when referring to these diseases.
If you have any questions about how Imatinib EG STADA works or why it has been prescribed for you, consult your doctor.

2. What you should know before taking Imatinib EG STADA

Imatinib EG STADA will only be prescribed by doctors experienced in medicines for the treatment of
blood cancers and solid tumors.
Carefully follow all instructions given by your doctor, even if they differ from the general information contained
in this leaflet.
DO NOT take Imatinib EG STADA

  • 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 EG STADA.
If you think you may be allergic but are unsure, seek advice from your doctor.
Warnings and precautions
Talk to your doctor before taking Imatinib EG STADA:

  • if you have or have had liver, kidney, 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 a hepatitis B infection. This is because Imatinib EG STADA may cause reactivation of hepatitis B, which in some cases can be fatal. Patients will be carefully monitored by the doctor for signs of this infection before starting treatment.
  • if you develop bruising, bleeding, fever, fatigue, or confusion while taking Imatinib EG STADA, contact your doctor. These may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA). If you are in any of these situations, consult your doctor before taking Imatinib EG STADA.

During treatment with Imatinib EG STADA, you may become more sensitive to sunlight. It is important to cover skin areas exposed to sunlight and to use sunscreen with a high sun protection factor (SPF).
These precautions also apply to children.
During treatment with Imatinib EG STADA, inform your doctor immediately if you gain weight rapidly. Imatinib EG STADA may cause your body to retain fluid (severe fluid retention).
While taking Imatinib EG STADA, 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 EG STADA 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 with MDS/MPD, DFSP, GIST, and HES/LEC.
Some children and adolescents taking Imatinib EG STADA may experience slower than normal growth. Your doctor will monitor growth at regular intervals.
Other medicines and Imatinib EG STADA
Inform 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 EG STADA when taken together. They may increase or decrease the effect of Imatinib EG STADA, leading to an increased risk of side effects or making Imatinib EG STADA less effective. Imatinib EG STADA may have similar effects on other medicines.
Inform your doctor if you are taking 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 with breast milk,
ask your doctor for advice before taking this medicine.

  • Imatinib EG STADA is not recommended during pregnancy unless absolutely necessary, as it may harm the unborn child. Your doctor will discuss with you the potential risks of taking Imatinib EG STADA during pregnancy.
  • Women who could become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
  • Do not breastfeed during treatment with Imatinib EG STADA and for 15 days after stopping treatment, as it may harm the infant.
  • Patients concerned about fertility during treatment with Imatinib EG STADA 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 EG STADA

Your doctor has prescribed Imatinib EG STADA because you suffer from a serious condition.
Imatinib EG STADA can help you fight this condition.
Take this medicine exactly as instructed by your doctor or pharmacist. It is important that you do so for the entire duration prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much Imatinib EG STADA to take

Use in adults
Your doctor will tell you exactly how many Imatinib EG STADA tablets you should take.

  • If you are being treated for CML: Depending on your condition, the recommended initial dose is 400 mg or 600 mg taken once daily.
  • If you are being treated for GIST: The initial dose is 400 mg, taken once daily.

For CML and GIST, your doctor may prescribe a higher or lower dosage depending on your response to treatment. If the daily dose is 800 mg, you must take 400 mg in the morning and 400 mg in the evening.

  • If you are being treated for Ph+ ALL: The initial dose is 600 mg, taken once daily.
  • If you are being treated for MDS/MPD: The initial dose is 400 mg, taken once daily.
  • If you are being treated for HES/CEL: The initial dose is 100 mg, taken once daily. Your doctor may decide to increase the dose to 400 mg, taken once daily, based on your response to treatment.
  • If you are being treated for DFSP: The dose is 800 mg per day, taken as 400 mg in the morning and 400 mg in the evening.

A dose of 400 mg can be taken as one 400 mg tablet or four 100 mg tablets.
A dose of 600 mg can be taken as one 400 mg tablet plus two 100 mg tablets, or as one 400 mg tablet plus half a 400 mg tablet.
The tablets can be divided in half by breaking them along the break line.

Use in children and adolescents
Your doctor will tell you how many Imatinib EG STADA tablets should be given to the child. The amount of Imatinib EG STADA 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. Treatment may be given 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).

When and how to take Imatinib EG STADA

  • Take Imatinib EG STADA during a meal. This will help protect your stomach when taking Imatinib EG STADA.
  • Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you may dissolve them in a glass of still water or apple juice:

  • Use about 50 mL for each 100 mg tablet or 200 mL for each 400 mg tablet.
  • Stir with a spoon until the tablets have completely dissolved.
  • Once the tablet has dissolved, drink the entire contents of the glass immediately. Residue from the dissolved tablets may remain in the glass.

How long to take Imatinib EG STADA
Continue taking Imatinib EG STADA every day for as long as your doctor tells you to.

If you take more Imatinib EG STADA than you should
If you accidentally take too many tablets, contact your doctor immediately. You may need medical assistance. Bring the medicine pack with you.

If you forget to take Imatinib EG STADA

  • If you forget 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 a forgotten dose.

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

If you have any doubts about how to use 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 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 EG STADA may cause your body to retain water (severe fluid retention).
  • Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib EG STADA can reduce the number of white blood cells, making you more susceptible to infections.
  • 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 of dizziness, lightheadedness 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, redness 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 in the brain/skull).
  • Paleness, feeling tired and short of breath, dark-coloured urine (signs of low red blood cell levels).
  • Eye pain or vision deterioration, bleeding in the eyes.
  • Bone or joint pain (signs of osteonecrosis).
  • Blisters on the skin or mucous membranes (signs of pemphigus).
  • Numbness or coldness in fingers or toes (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 abnormal heartbeat (signs of changes in blood potassium levels).
  • Bruising (contusions).
  • Stomach pain with feeling unwell (nausea).
  • Muscle spasms with fever, red-brown urine, muscle pain or weakness (signs of muscle problems).
  • Pelvic pain sometimes with nausea and vomiting, vaginal bleeding, dizziness or fainting due to low blood pressure (signs of problems with ovaries and uterus).
  • Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue 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).
  • Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the 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 (jaundice) with shortness of breath, chest pain/discomfort, marked decrease in urine production and feeling thirsty, etc. (signs of a treatment-related allergic reaction).
  • Chronic kidney failure.
  • Reactivation (recurrence) of hepatitis B infection if you have previously had hepatitis B (a liver infection).

If you experience any of the effects listed above, contact your doctor immediately.
Other possible 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, muscle or bone pain during treatment with Imatinib EG STADA or after stopping Imatinib EG STADA.
  • 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 bloating, 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.

Uncommon (may affect up to 1 in 100 people):

  • Painful red nodules on the skin, skin pain, skin redness (inflammation of subcutaneous fatty tissue).
  • Cough, runny or blocked nose, feeling of heaviness or pain when pressing the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
  • Severe headache felt as a pulsating pain or throbbing sensation, usually on one side of the head and often accompanied by nausea, vomiting and sensitivity to light or sound (signs of migraine).
  • Flu-like symptoms (influenza).
  • Pain or burning sensation while urinating, increased body temperature, pain in the groin or pelvic area, red or brown or cloudy urine (signs of urinary tract infection).
  • Pain and swelling of joints (signs of arthralgia).
  • Persistent feeling of sadness and loss of interest, preventing you from carrying out your normal activities (signs of depression).
  • A feeling of apprehension and worry together with physical symptoms such as palpitations, sweating, trembling, dry mouth (signs of anxiety).
  • Drowsiness/lethargy/excessive sleepiness.
  • Tremor or shaky movements (tremor).
  • Memory problems.
  • Uncontrollable urge to move the legs (restless legs syndrome).
  • Hearing noises in the ears (e.g. ringing, buzzing) that have no external source (tinnitus).
  • High blood pressure (hypertension).
  • Belching.
  • Inflammation of the lips.
  • Difficulty swallowing.
  • Increased sweating.
  • Change in skin colour.
  • Brittle nails.
  • Red bumps or white-headed boils around hair roots, possibly with pain, itching or burning sensation (signs of inflammation of hair follicles, also called folliculitis).
  • Skin rash with peeling or shedding (exfoliative dermatitis).
  • Breast enlargement (can occur in men or women).
  • Dull and/or heavy feeling in testicles or lower abdomen, pain while urinating, during sexual intercourse or ejaculation, blood in urine (signs of testicular oedema).
  • Inability to achieve or maintain an erection (erectile dysfunction).
  • Heavy or irregular menstrual periods.
  • Difficulty achieving/maintaining sexual arousal.
  • Decreased sexual desire.
  • Nipple pain.
  • General feeling of being unwell (malaise).
  • Viral infection such as cold sores.
  • Lower back pain due to kidney disease.
  • Increased frequency of urination.
  • Increased appetite.
  • Pain or burning sensation in the upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, dark-coloured stools (signs of stomach ulcer).
  • Stiffness of joints and muscles.
  • Abnormal laboratory test results. If any of these effects become severe, contact your doctor.

Rare (may affect up to 1 in 1,000 people):

  • Confusion.
  • Change in nail colour.

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.
  • Painful skin lesions and/or blistering.
  • Slowed growth in children and adolescents. If any of these effects become severe, contact your doctor.

Reporting of side effects
If you experience 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 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 EG STADA

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton or blister after Exp. The expiry date refers to the last day of that month.
  • Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
  • Do not use the pack if damaged or shows signs of tampering.

6. Package contents and other information

What Imatinib EG STADA contains
The active substance is imatinib mesilate.
Imatinib EG STADA 100 mg film-coated tablets
Each film-coated tablet contains imatinib mesilate equivalent to 100 mg of imatinib.
Imatinib EG STADA 400 mg film-coated tablets
Each film-coated tablet contains imatinib mesilate equivalent to 400 mg of imatinib.
The other components are: microcrystalline cellulose, hypromellose (E464), crospovidone, anhydrous colloidal silica, and magnesium stearate (E572).
The tablet coating consists of: hypromellose (E464), yellow iron oxide (E172), red iron oxide (E172), and talc (E553b).

Description of the appearance of Imatinib EG STADA and pack contents
Imatinib EG STADA 100 mg are film-coated, biconvex, round tablets, light yellow to dark yellow-brown in colour, with a breakline on one side, an average thickness of approximately 3.5 mm, and a diameter of approximately 9.2 mm.
Imatinib EG STADA 100 mg film-coated tablets are available in PVC/PE/PVDC/Aluminium blisters containing 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.

Imatinib EG STADA 400 mg are film-coated, biconvex, oval tablets, light yellow to dark yellow-brown in colour, with a breakline on one side, an average thickness of approximately 7.3 mm, a length of approximately 18.4 mm, and a width of approximately 7.3 mm.
Imatinib EG STADA 400 mg film-coated tablets are available in PVC/PE/PVDC/Aluminium blisters containing 30x1, 60x1 or 90x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel – Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
DE Imatinib STADA 100 mg Filmtabletten
Imatinib STADA 400 mg Filmtabletten
IT Imatinib EG STADA
NL Imatinib STADA 100 mg, filmomhulde tabletten
Imatinib STADA 400 mg, filmomhulde tabletten