Imatinib altan

Package leaflet: Information for the patient

Imatinib Altan, 400 mg, hard capsules
Imatynib
This medicinal product will be subject to additional monitoring. This will allow rapid identification of new safety information. Patients can also help by reporting any suspected adverse reactions that occur after starting treatment. For information on how to report adverse reactions – see section 4.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Imatinib Altan is and what it is 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 pack and other information

1. What Imatinib Altan is and what it is used for
Imatinib Altan is a medicine containing the active substance called imatynib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.
Imatinib Altan is indicated for the treatment of adult patients and children with:

• Philadelphia chromosome-positive acute lymphoblastic leukaemia ( Ph-positive ALL). Leukaemia is a cancer arising from white blood cells. Normally, white blood cells help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia 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 diseases (MDS/MPD). These are blood disorders 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) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders 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). DFSP is a cancer of the skin and subcutaneous tissues in which certain cells begin to multiply uncontrollably. Imatinib Altan inhibits the growth of these cells.

In the remainder of this leaflet, the abbreviated names of the diseases listed above will be used.
If you have any questions about how Imatinib Altan works or why it has been prescribed, please consult your doctor.

2. Important information before taking Imatinib Altan

Imatinib Altan is prescribed only by doctors experienced in the use of medicines for the treatment of haematological malignancies or solid tumours.
You must strictly follow your doctor's instructions, even if they differ from the general information provided in this leaflet.

When not to take Imatinib Altan:

• if you are allergic to imatynib or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, you must inform your doctor before taking Imatinib Altan. If you suspect an allergy but are unsure, seek medical advice.

Warnings and precautions
Before starting Imatinib Altan, discuss the following with your doctor:

• if you have or have ever had liver, kidney, or heart disease
• if you are taking levothyroxine after thyroid removal
• if you have ever had or may currently have hepatitis B virus infection. This is important because Imatinib Altan may cause reactivation of hepatitis B virus infection, which in some cases may be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.
• if you develop bruising, bleeding, fever, fatigue, or confusion while taking Imatinib Altan, contact your doctor immediately. These may be symptoms of a blood vessel disorder called thrombotic microangiopathy (TMA).

If any of the above points apply to you, you must inform your doctor before taking Imatinib Altan.
Tell your doctor immediately if you experience a rapid weight gain while being treated with Imatinib Altan. Imatinib Altan may cause fluid retention (severe fluid retention).
While taking Imatinib Altan, your health status will be regularly assessed by your doctor to monitor the effectiveness of treatment. Blood tests and body weight measurements will be performed regularly during treatment with this medicine.

Children and adolescents
Experience with use in children with Ph-positive ALL is limited, and experience 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. Your doctor will monitor growth during regular visits.

Imatinib Altan and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines (such as paracetamol) and herbal medicines (such as St John's wort). Some medicines may affect the action of Imatinib Altan when taken at the same time. They may increase or decrease the effect of Imatinib Altan, leading to increased side effects or reduced effectiveness. Similarly, Imatinib Altan may affect the action of some other medicines.
Tell your doctor if you are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
• Imatinib Altan is not recommended for use during pregnancy unless clearly necessary, as it may harm the unborn child. Your doctor will discuss the potential risks associated with taking Imatinib Altan during pregnancy.
• Women of childbearing potential are advised to use effective contraception during treatment with Imatinib Altan.
• Do not breastfeed while taking Imatinib Altan.
• Patients concerned about the effect of imatynib on fertility during treatment with Imatinib Altan should consult their doctor.

Driving and using machines
Dizziness, drowsiness, or blurred vision may occur while taking Imatinib Altan. If this happens, do not drive or operate tools or machinery until you feel well again.

Imatinib Altan contains sunset yellow (E110).
This medicine may cause allergic reactions.

3. How to take Imatinib Altan

Your doctor has prescribed Imatinib Altan because of your serious medical condition.
Imatinib Altan may help improve this condition.
However, this medicine must always be taken exactly as directed by your doctor or pharmacist. It is important to take the medicine for as long as your doctor or pharmacist has instructed. If in doubt, consult your doctor or pharmacist.
Do not stop taking Imatinib Altan unless your doctor tells you to do so. If you are unable to take the prescribed medicine or think you no longer need it, you should contact your doctor immediately.

What dose of Imatinib Altan should be taken?

Use in adult patients

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

• For treatment of Ph-positive ALL: The starting dose is 600 mg taken once daily as one 400 mg capsule and two 100 mg capsules.
• For treatment of MDS/MPD: The starting dose is 400 mg taken once daily as one capsule.
• For treatment of HES/CEL: The starting dose is 100 mg taken once daily as one capsule. Your doctor may decide to increase the dose to 400 mg taken once daily as one 400 mg capsule, depending on how you respond to treatment.
• For treatment of DFSP: The daily dose is 800 mg (2 capsules), taken as one capsule in the morning and one in the evening.

Use in children and adolescents

Your doctor will determine the number of Imatinib Altan capsules to give to the child. The dose of Imatinib Altan will depend on the child's condition, body weight, and height. The total daily dose in children must not exceed 600 mg in the treatment of Ph-positive ALL. The dose may be given once daily or divided into two doses (half in the morning and half in the evening).

When and how to take Imatinib Altan

• Imatinib Altan should be taken with food to protect the stomach during treatment.
• Capsules must be swallowed whole with a large glass of water. Do not open or crush the capsules unless the patient has difficulty swallowing (e.g. in children).
• If a patient cannot swallow the capsules, they may be opened and the powder mixed into a glass of non-carbonated water or apple juice (each 100 mg capsule should be dissolved in approximately 50 ml of water/apple juice). Once the capsule has dissolved, the entire contents of the glass should be drunk immediately. Some residue of the dissolved capsule may remain in the glass.

How long should Imatinib Altan be taken?

Imatinib Altan should be taken every day for as long as your doctor has instructed.

Accidentally taking more than the recommended dose of Imatinib Altan

Patients who have accidentally taken too many capsules should tell their doctor immediately, as they may require medical attention. Take the medicine packaging with you.

Missed dose of Imatinib Altan

• If you forget to take 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 missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
They are usually mild to moderate.
Some adverse reactions may be serious. You must immediately inform your doctor if you experience any of the following adverse symptoms:
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).
• Signs of infection, such as fever, severe chills, sore throat, and mouth ulcers. Imatinib Altan may reduce the number of white blood cells in the blood, which may increase susceptibility to infection.
• Unexpected bleeding or bruising (despite no injury).

Uncommon (may affect up to 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 faint, 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, stools, or urine, black stools (symptoms of gastrointestinal disorders).
• Significantly reduced urine output, feeling thirsty (symptoms of kidney problems).
• Nausea with diarrhoea 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 within the skull/brain).
• Pale skin, feeling tired and short of breath, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or blurred vision, bleeding in the eyes.
• Hip pain or difficulty walking.
• Numbness or cold sensation in 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 muscle cramps with irregular heartbeat (symptoms of changes in potassium levels in the patient's blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, red-brown discoloration of urine, muscle pain and weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, 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 complaints accompanied by abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium, and low levels of phosphorus in the blood).
• Painful red nodules on the skin, skin pain, redness of the skin (inflammation of the fatty tissue beneath 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 available data):

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

If you experience any of the above adverse symptoms, you must immediately inform your doctor.
Other adverse reactions may include:
Very common (may affect more than 1 in 10 people):

• Headache or fatigue.
• Nausea, vomiting, diarrhoea, indigestion.
• Rash.
• Muscle or joint cramps, muscle or bone pain, during or after discontinuation of Imatinib Altan.
• Swelling, such as in the ankles or around the eyes.
• Weight gain.

If any of the above symptoms worsen, you should inform your doctor.
Common (may affect up to 1 in 10 people):

• Loss of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep difficulties (insomnia).
• Eye discharge with itching, redness, and swelling (conjunctivitis), excessive 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.
• Dryness of the mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flushes, chills, or night sweats.

If any of the above symptoms occur, you should inform your doctor.
Frequency not known (cannot be estimated from available data):

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

If any of the above symptoms occur, you should inform your doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Imatinib Altan

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard package.
• Do not store above 30°C.
• Store in the original packaging to protect from moisture.
• Do not use the medicine if the packaging is damaged or shows signs of having been opened.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Imatinib Altan contains

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

What Imatinib Altan looks like and contents of the pack
Imatinib Altan 400 mg hard gelatin capsules: the capsules are white or almost white (body and cap),
size 00, with an orange print "400".
Imatinib Altan 400 mg hard gelatin capsules are packed in white HDPE bottles with a child-resistant closure and a tamper-evident ring (the whole made of PP).
They are available in packaging containing 30 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharma Ltd
2 Harbour Square
Cofton Road
Dun Laogharie, County Dublin
A96 D6R0
Ireland
Manufacturer
Nobilus Ent
ul. Warszewska 45
01-821 Warszawa
Poland
This medicinal product is authorised in the European Economic Area member states under the following names:
United Kingdom Imatinib Altan 400 mg hard capsules
Portugal Imatinib Altan 400 mg cápsulas moles MG
Spain Imatinib Altan 400 mg cápsulas duras EFG