Imatinib Altan

Leaflet attached to the packaging: patient information

Imatinib Altan, 400 mg, hard capsules

Imatinib
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. The medicine user can also help by reporting any side effects they experience while taking the medicine. To learn how to report side effects, see section 4.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects 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 Altan and what is it used for
• 2. Important information before taking Imatinib Altan
• 3. How to take Imatinib Altan
• 4. Possible side effects
• 5. How to store Imatinib Altan
• 6. Contents of the packaging and other information

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

Imatinib Altan is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the course of the diseases listed below. These include certain types of cancer.

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

• Acute lymphoblastic leukemia with Philadelphia chromosome (English Ph-positive ALL). Leukemia is a cancer that originates from white blood cells. Usually, 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) begin to multiply uncontrollably. Imatinib Altan inhibits the growth of these cells.

Imatinib Altan is also indicated for the treatment of adult patients with:

• Myelodysplastic/myeloproliferative syndromes (MDS/MPD- English myelodysplastic/myeloproliferate). These are blood diseases in which certain white blood cells begin to multiply uncontrollably. Imatinib Altan inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES- English Hypereosinophilic Syndrome) and (or) chronic eosinophilic leukemia CEL- English Chronic Eosinophilic Leukemia). These are blood diseases in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Imatinib Altan inhibits the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP -English dermatofibrosarcoma protuberans). DFSP is a skin and subcutaneous tissue cancer in which certain cells begin to multiply uncontrollably. Imatinib Altan inhibits the growth of these cells.

In the rest of the leaflet, abbreviations of the names of the diseases listed above will be used.
If you have any questions about how the medicine works or its justification, you should consult a doctor.

2. Important information before taking Imatinib Altan

Imatinib Altan is prescribed to patients only by doctors with experience in using medicines for the treatment of blood cancers or solid tumors.
You should strictly follow the doctor's recommendations, even if they differ from the general information contained in this leaflet.

When not to take Imatinib Altan:

• 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

Imatinib Altan.

In case of suspected allergy, but uncertainty, medical advice should be sought.

Warnings and precautions

Before starting Imatinib Altan, you should discuss it with your 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 a hepatitis B virus infection
• This is important because Imatinib Altan may cause reactivation of hepatitis B virus infection, which can be fatal in some cases. Patients will be closely monitored by their doctor to detect signs of this infection before starting treatment.
• if the patient experiences bruising, bleeding, fever, fatigue, and disorientation while taking Imatinib Altan, they should contact their doctor. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).

If any of the above points apply to the patient, they should tell their doctor before taking Imatinib Altan.
The patient should immediately tell their doctor if they experience a very rapid increase in weight during treatment with Imatinib Altan.
Imatinib Altan may cause fluid retention in the body (severe fluid retention).
During treatment with Imatinib Altan, the patient's health will be regularly assessed by their doctor to determine if the treatment is effective. Blood tests and weight measurements will be regularly performed while taking this medicine.

Children and adolescents

Experience with the use of Imatinib Altan in children with Ph-positive ALL is limited, and experience with the use of Imatinib Altan in children with MDS/MPD, DFSP, and HES/CEL is very limited.
In some children and adolescents taking Imatinib Altan, growth may be slower than normal. The doctor will monitor growth during regular visits.

Imatinib Altan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those that are available without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may affect the action of Imatinib Altan if taken at the same time. They may increase or decrease the action of Imatinib Altan, which can lead to increased side effects or make Imatinib Altan less effective. Similarly, Imatinib Altan may affect some other medicines.
The patient should tell their doctor if they are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
• Imatinib Altan is not recommended for pregnant women unless absolutely necessary, as it may harm the baby. The doctor will discuss the possible risks that may occur during treatment with Imatinib Altan during pregnancy.
• Women who may become pregnant should use effective contraception during treatment with Imatinib Altan.
• The patient should not breastfeed while taking Imatinib Altan.
• Patient concerned about the effect of imatinib on their fertility during treatment with Imatinib Altan should consult their doctor.

Driving and using machines

While taking Imatinib Altan, dizziness, drowsiness, or vision disturbances may occur. In such cases, the patient should not drive or operate any tools or machines until they feel better.

Imatinib Altan contains orange yellow (E110),

The medicine may cause allergic reactions.

3. How to take Imatinib Altan

The doctor has prescribed Imatinib Altan because of the patient's serious condition. Imatinib Altan may help improve this condition.
However, this medicine should always be used in accordance with the doctor's or pharmacist's recommendations. It is important to use the medicine for as long as the doctor or pharmacist recommends. If in doubt, the patient should consult their doctor or pharmacist.
The patient should not stop taking Imatinib Altan unless their doctor recommends it. If the patient cannot take the prescribed medicine or thinks they do not need it, they should immediately contact their doctor.

In what dose is Imatinib Altan taken

Use in adult patients

The doctor will determine the exact number of Imatinib Altan capsules to take.

• In the case of Ph-positive ALL treatmentThe initial dose is 600 mg, taken as one 400 mg capsule and two 100 mg capsules oncea day.
• In the case of MDS/MPD treatmentThe initial dose is 400 mg, taken as one capsule oncea day
• In the case of HES/CEL treatmentThe initial dose is 100 mg, taken as 1 capsule oncea day. The doctor may decide to increase the dose to 400 mg taken as one 400 mg capsule oncea day, depending on the patient's response to treatment.
• In the case of DFSP treatmentThe daily dose is 800 mg (2 capsules), taken as one capsule in the morning and one in the evening.

Use in children and adolescents

The doctor will determine the amount of Imatinib Altan capsules to give to the child. The dose of Imatinib Altan will depend on the child's condition and their weight and growth. The total daily dose in children should not exceed 600 mg in the treatment of Ph-positive ALL. The dose can be given to the child once a day or divided into two doses (half the dose in the morning and half the dose in the evening).

When and how to take Imatinib Altan

• Imatinib Altan should be taken with foodto protect the stomach while taking Imatinib Altan.
• Capsules should be swallowed whole, with a large glass of water.Do not open, do not crush capsules unless the patient has swallowing problems (e.g., in children).
• If the patient is unable to swallow capsules, they can be opened and the powder poured into a glass of still water or apple juice (each 100 mg capsule should be dissolved in approximately 50 ml of water/juice). When the capsule dissolves, the patient should immediately drink the entire contents of the glass. Residues of the dissolved capsule may remain on the glass.

How long to take Imatinib Altan

Imatinib Altan should be taken every day for as long as the doctor recommends.

Taking a higher dose of Imatinib Altan than recommended

Patient who have taken too many capsules by mistake should immediately tell their doctor, as they may require medical attention. The patient should take the packaging of the medicine with them.

Missing a dose of Imatinib Altan

• 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, they should skip the missed dose.
• Then continue with the usual dosing schedule.
• Do not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

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

Very common(may affect more than 1 in 10 people) or common(may affect less than 1 in 10 people):

• Rapid weight gain. Imatinib Altan may cause fluid retention in the body (severe fluid retention).
• Infection symptoms, such as fever, severe chills, sore throat, and mouth ulcers. Imatinib Altan may decrease the number of white blood cells in the blood, which can increase the risk of infection.
• Unexpected bleeding or bruising (even without injury).

Uncommon(may affect no more than 1 in 100 people) or rare (may affect less than 1 in 1,000 people):

• 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).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms of liver problems).
• Rash, redness of the skin with blisters on the lips, around the eyes, on the skin, or in the mouth, peeling of the skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).
• Severe abdominal pain, presence of blood in vomit, stool, or urine, black stools (symptoms of stomach and intestine disorders).
• Significantly reduced amount of urine, feeling of thirst (symptoms of kidney problems).
• Nausea with diarrhea and vomiting, 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).
• Pallor, feeling of fatigue and shortness of breath, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or vision disturbances, 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 the patient's blood potassium levels).
• Bruising.
• Abdominal pain with nausea.
• Muscle cramps with fever, reddish-brown urine, muscle pain, or 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 laboratory test abnormalities (e.g., high potassium, uric acid, and calcium levels and low phosphorus levels in the blood).
• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin).

Rare (may affect less than 1 in 1,000 people):

• Blood clots in small blood vessels (thrombotic microangiopathy)

Frequency not known(cannot be estimated from the available data):

• Co-occurrence of widespread, severe rash, nausea, fever, high levels of certain white blood cells, or yellowing of the skin or eyes (symptoms of jaundice) with shortness of breath, pain, and (or) discomfort in the chest, significantly reduced amount of urine, and feeling of thirst, etc. (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Relapse (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(may affect more than 1 in 10 people):

• Headache or fatigue.
• Nausea, vomiting, diarrhea, indigestion.
• Rash.
• Muscle cramps or joint pain, muscle pain, or bone pain during or after taking Imatinib Altan.
• 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(may affect no more than 1 in 10 people):

• Lack of appetite, weight loss, or taste disorders.
• Dizziness or weakness.
• Sleep disturbances (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 the patient experiences any of the above side effects, they should tell their doctor.
Frequency not known(cannot be estimated from the available data):

• Redness or swelling of the palms and soles, which may be accompanied by tingling and burning pain.
• Slowed growth in children and adolescents.

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Imatinib Altan

• The medicine should be stored out of 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 from moisture.
• Do not use medicine from damaged or opened packaging.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Imatinib Altan contains

• The active substance of the medicine is imatinib (in the form of imatinib mesylate). One capsule contains 400 mg of imatinib (in the form of imatinib mesylate).
• The medicine does not contain excipients. The capsule contains only imatinib (in the form of imatinib mesylate).
• The capsule shell consists of titanium dioxide (E171) and gelatin.
• The ink contains: shellac, titanium dioxide (E171), concentrated ammonia solution, propylene glycol, and orange yellow (E110).

What Imatinib Altan looks like and what the pack contains

Imatinib Altan, hard capsules 400 mg: capsules are white or almost white (body and cap), size 00, with orange printing "400".
Imatinib Altan, hard capsules 400 mg are packaged in white HDPE bottles with a child-resistant cap with a guarantee ring (all made of PP).
They are supplied in packs containing 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder
Altan Pharma Ltd
2 Harbour Square
Cofton Road
Dun Laoghaire, County Dublin
A96 D6R0
Ireland
Manufacturer
Nobilus Ent
ul. Swarzewska 45
01-821 Warsaw
Poland

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

United Kingdom

Imatinib Altan 400 mg hard capsules

Portugal

Imatinib Altan 400 mg capsula MG

Spain

Imatinib Altan 400 mg cápsulas duras EFG

Date of last revision of the leaflet: May 2022