IMATINIB 100 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Imatinib Adamed Pharma, 100 mg, hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Imatinib Adamed Pharma and what is it used for
   1. Imatinib Adamed Pharma is indicated for the treatment of adult patients and children with:
   2. Imatinib Adamed Pharma is indicated for the treatment of adult patients with:
4. Important information before taking Imatinib Adamed Pharma
   1. When not to take Imatinib Adamed Pharma
   2. Warnings and precautions
   3. The patient should immediately tell their doctor if they experience:
   4. Children and adolescents
   5. Imatinib Adamed Pharma and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Imatinib Adamed Pharma contains lactose monohydrate
5. How to take Imatinib Adamed Pharma
   1. How to take Imatinib Adamed Pharma
   2. How long to take Imatinib Adamed Pharma
   3. If the patient takes more Imatinib Adamed Pharma than they should
   4. If the patient forgets to take Imatinib Adamed Pharma
6. Possible side effects
   1. Some side effects may be serious. The patient should immediately tell their doctor if they experience any of the following side effects.
   2. Very common or common side effects:
   3. Uncommon or rare side effects:
   4. Frequency not known:
   5. Other side effects may include:
   6. Common side effects:
   7. Frequency not known:
   8. If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
   9. Reporting side effects
7. How to store Imatinib Adamed Pharma
8. Contents of the packaging and other information
   1. What Imatinib Adamed Pharma contains
   2. What Imatinib Adamed Pharma looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Imatinib Adamed Pharma, 100 mg, hard capsules

Imatinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Imatinib Adamed Pharma and what is it used for
• 2. Important information before taking Imatinib Adamed Pharma
• 3. How to take Imatinib Adamed Pharma
• 4. Possible side effects
• 5. How to store Imatinib Adamed Pharma
• 6. Contents of the packaging and other information

1. What is Imatinib Adamed Pharma and what is it used for

Imatinib Adamed Pharma is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the following diseases.

Imatinib Adamed Pharma is indicated for the treatment of adult patients and children with:

• Chronic myeloid leukemia (CML)- English: Chronic Myeloid Leukaemia). Leukemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) start to multiply out of control. In adult patients, Imatinib Adamed Pharma is used to treat the late stage of chronic myeloid leukemia called blast crisis. However, in children and adolescents, it may be used to treat all stages of the disease.

Imatinib Adamed Pharma is indicated for the treatment of adult patients with:

• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL). Leukemia is a cancer of the white blood cells. Normally, white blood cells help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) start to multiply out of control. Imatinib Adamed Pharma inhibits the growth of these cells.
• Myelodysplastic/myeloproliferative diseases (MDS/MPD)- English: myelodysplastic/myeloproliferative). These are blood diseases in which certain white blood cells start to multiply out of control.

Imatinib Adamed Pharma inhibits the growth of these cells in certain subtypes of these diseases.

• Hypereosinophilic syndrome (HES) and (or) chronic eosinophilic leukemia (CEL)- English: Hypereosinophilic Syndromeand Chronic Eosinophilic Leukemia). These are blood diseases in which certain blood cells (called eosinophils) start to multiply out of control. Imatinib Adamed Pharma inhibits the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP)- English: dermatofibrosarcoma protuberans). DFSP is a skin cancer in which certain cells start to multiply out of control. Imatinib Adamed Pharma inhibits the growth of these cells.

In the rest of the leaflet, abbreviations of the disease names mentioned above will be used.

2. Important information before taking Imatinib Adamed Pharma

Imatinib Adamed Pharma is prescribed to patients only by doctors with experience in using medicines for the treatment of blood cancers or solid tumors.

When not to take Imatinib Adamed Pharma

• if the patient is allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this information applies to the patient, they should tell their doctor before taking the medicine.

Warnings and precautions

Before starting treatment with Imatinib Adamed Pharma, the patient should discuss the following with their doctor:

• if the patient has or has had liver, kidney, or heart disease
• if the patient is taking levothyroxine after thyroid removal.
• if the patient has or may have had hepatitis B virus infection; this is because Imatinib Adamed Pharma may cause the hepatitis B virus to become active again, which can be life-threatening; patients will be closely monitored by their doctor for signs of this infection before starting treatment.

If any of the above points apply to the patient, they should tell their doctor before taking Imatinib Adamed Pharma.

The patient should immediately tell their doctor if they experience:

very rapid weight gain. Imatinib Adamed Pharma may cause water retention in the body (severe fluid retention).

Children and adolescents

Imatinib Adamed Pharma is also used to treat children and adolescents with CML. There is no experience with the use of Imatinib Adamed Pharma in children with CML under 2 years of age.

Imatinib Adamed Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, including those obtained without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.

Driving and using machines

While taking this medicine, the patient may experience dizziness or drowsiness or vision disturbances.

Imatinib Adamed Pharma contains lactose monohydrate

If the patient has been told they have an intolerance to some sugars, they should inform their doctor before taking Imatinib Adamed Pharma.

3. How to take Imatinib Adamed Pharma

The doctor has prescribed Imatinib Adamed Pharma because of the patient's serious condition.

How to take Imatinib Adamed Pharma

• Imatinib Adamed Pharma should be taken with foodto protect the stomach while taking Imatinib Adamed Pharma.
• The capsules should be swallowed whole, with a large glass of water.The capsules should not be opened or crushed unless the patient has problems swallowing them (e.g., in children).
• If the patient is unable to swallow the capsules, they can be opened and the contents dissolved in a glass of still water or apple juice.

How long to take Imatinib Adamed Pharma

The patient should take Imatinib Adamed Pharma every day for as long as their doctor recommends.

If the patient takes more Imatinib Adamed Pharma than they should

Patient who have taken too many capsules should immediatelytell their doctor, as they may need medical attention.

If the patient forgets to take Imatinib Adamed Pharma

• If the patient forgets to take a dose, they should take it as soon as they remember.
• However, if it is almost time for the next dose, the patient should skip the missed dose.
• The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Imatinib Adamed Pharma can cause side effects, although not everybody gets them.

Some side effects may be serious. The patient should immediately tell their doctor if they experience any of the following side effects.

Very common or common side effects:

• Rapid weight gain. Imatinib Adamed Pharma may cause water retention in the body (severe fluid retention).
• Infection symptoms, such as fever, chills, sore throat, and mouth ulcers. Imatinib Adamed Pharma may reduce the number of white blood cells in the blood, making the patient more prone to infection.
• Unexplained bleeding or bruising (even without injury).

Uncommon or rare side effects:

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or pain when breathing (symptoms of lung problems).
• Feeling of emptiness in the head, dizziness, or fainting (symptoms of low blood pressure).
• Loss of appetite and weight loss or taste disorders.
• Rash, redness of the skin with blisters on the lips, around the eyes, on the skin, or in the mouth, peeling skin, fever, elevated red or purple spots on the skin, itching, burning sensation, blistering rash.
• Severe abdominal pain, blood in vomit, stools, or urine, black stools (symptoms of stomach and intestine problems).
• Significantly reduced urine output, feeling of thirst (symptoms of kidney problems).
• Diarrhea with vomiting and abdominal pain or fever (symptoms of intestinal problems).
• Severe headache, weakness, or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (symptoms of nervous system problems, such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of tiredness and shortness of breath, and dark urine color (symptoms of anemia).
• Eye pain or vision problems, bleeding in the eyes.
• Hip or walking difficulties.
• Numbness or feeling of cold in the fingers and toes (symptoms of Raynaud's syndrome).
• Sudden swelling and redness of the skin (symptoms of skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and cramps with irregular heartbeat (symptoms of changes in potassium levels in the blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine color, pain, and weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (symptoms of ovarian or uterine problems).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and (or) joint problems with accompanying laboratory test abnormalities (e.g., high potassium, uric acid, and calcium levels and low phosphorus levels in the blood).

Frequency not known:

• Co-occurrence of widespread, severe rash, nausea, fever, high white blood cell count, or jaundice (yellowing of the skin or eyes) with shortness of breath, chest pain or discomfort, significantly reduced urine output, and feeling of thirst (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who have had the disease in the past.

If the patient experiences any of the above side effects, they should immediately tell their doctor.

Other side effects may include:

Very common side effects:

• Headache or feeling of tiredness.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps or joint or muscle pain.
• Swelling, such as swelling of the ankles or around the eyes.
• Weight gain. If any of the above side effects worsen, the patient should tell their doctor.

Common side effects:

• Lack of appetite, weight loss, or taste disorders.
• Dizziness or weakness.
• Sleep difficulties (insomnia).
• Eye discharge with itching, redness, and swelling (conjunctivitis), increased tearing, or blurred vision.
• Nosebleeds.
• Abdominal pain or swelling, bloating with gas, heartburn, or constipation.
• Itching.
• Excessive hair loss or thinning.
• Numbness of 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 the above side effects worsen, the patient should tell their doctor.

Frequency not known:

• Redness and (or) swelling of the palms and soles, which may be accompanied by tingling and burning pain.
• Slowed growth in children and adolescents. If any of the above side effects worsen, the patient should tell their doctor.

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

5. How to store Imatinib Adamed Pharma

• Do not store above 30°C.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after "EXP:".
• Do not use the medicine if the packaging is damaged or shows signs of opening.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the packaging and other information

What Imatinib Adamed Pharma contains

• The active substance is imatinib (in the form of imatinib mesylate). Each Imatinib Adamed Pharma capsule contains 100 mg of imatinib (in the form of imatinib mesylate).
• The other ingredients are: crospovidone (type A), lactose monohydrate, and magnesium stearate.
• The capsule contains gelatin, iron oxide yellow (E 172), titanium dioxide (E 171), and iron oxide red (E 172).

What Imatinib Adamed Pharma looks like and contents of the pack

Imatinib Adamed Pharma, 100 mg, hard capsules are orange gelatin capsules, size "3". They are available in packs of 30, 60, 100, 120, or 180 capsules. Not all pack sizes may be available in the country.

Marketing authorization holder

Adamed Pharma S.A.

Manufacturer

Polfa Pabianice S.A.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France Imatinib Adamed Pharma

Poland Imatinib Adamed Pharma

Date of last revision of the leaflet: