Banolib should be taken exactly as prescribed by your doctor.

Follow all your doctor’s instructions carefully, even if they differ from the general information contained in this leaflet.

Warnings and precautions:

Talk to your doctor before taking Banolib.

Take special care with Banolib:

- If you have suffered prior cardiovascular events or if you have risk factors for cardiovascular disease.

- If you suffer from lack of potassium or magnesium.

- If you have a liver or pancreas disorder.

- If you have symptoms such as easy bruising, feeling tired or short of breath or have experienced repeated infections.

- If you have had a surgical procedure involving the removal of the entire stomach.

- If you have ever had or might now have a hepatitis B infection. This is because Banolib could cause hepatitis B to become active again, which can be fatal in some cases.

- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol), chemical drugs (such as warfarin) and herbal medicines.

Pregnancy, breastfeeding and fertility:

Banolib is not recommended during pregnancy unless clearly necessary as it may harm baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women who might get pregnant are advised to use highly effective contraception during treatment and for up to two weeks after ending treatment.

Children and adolescents:

Banolib is a treatment for children and adolescents with CML. There is no experience with the use of this medicine in children below 2 years of age.

Driving and using machines:

If you experience side effects (such as dizziness or visual disorders) after taking this medicine, you should refrain from these activities until the effect has disappeared.

Contraindications:

If you are allergic to Nilotinib.

However, always take this medicine exactly as your doctor or pharmacist has told you. Do not stop taking Banolib unless your doctor tells you to.

Swallow the hard capsules whole with water. Do not take any food together with capsules.

Do not open the hard capsules unless you are unable to swallow them. If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately.

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Then continue with your normal schedule.

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate. Tell your doctor or pharmacist straight away if you get any of the following:

Headache, vertigo, tiredness, diarrhea, nausea, constipation, mouth sores, stomach discomfort after meals, flatulence, swelling or bloating of the abdomen, abnormal appetite, taste altered, weight changes, hair loss, musculoskeletal pain, muscle spasms, increased risk of infection, insomnia, depression, anxiety, excessive sweating, skin reactions, eye disorders, nose bleed, edema, anemia, cardiac conduction disorders.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

Do not store above 30°C. Store in the original package in order to protect from moisture.

Banolib comes in 30 capsules in one bottle. Each capsule contains 200 mg Nilotinib hydrochloride monohydrate (active substance).

Any unused medicinal products after the end of treatment or by the expiry date should be returned in their original packaging to the place of supply (physician or pharmacist) for proper disposal.