Baratent 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 Baratent.

Take special care with Baratent:

- If you have or have had any cardiovascular problems, high blood pressure, blood disease, bleeding problems.

- If you have thyroid glands problems.

- If you have or have had pancreatic or gallbladder disorders.

- If you have or have had liver or kidney problems.

- If you are going to have surgery or if you had an operation recently.

- You may be advised to have a dental check-up before you start treatment with Baratent, tell your dentist that you are being treated with Baratent.

- If you have or have had skin and subcutaneous tissue disorders.

- If you have or have had seizures.

- If you have diabetes.

- If you have or have had pain or sores in the mouth

- 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:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Women who might become pregnant are advised to use effective contraception during treatment.

Children and adolescents:

Baratent is not recommended for people aged under 18.

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 sunitinib.

Always take this medicine exactly as your doctor or pharmacist has told you. Do not stop taking Baratent unless your doctor tells you to.

Baratent can be taken with or without food. This medicine may colour urine that is harmless.

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:

Tiredness, mouth dryness/ulcers, taste altered, nausea, vomiting, diarrhea, constipation, loss of appetite, weight loss, hair loss, liver failure, hypothyroidism, dizziness, headache, insomnia, hair color change, rash, cough, shortness of breath, increased risk of infections, reduction in the number of blood cells, hypoglycemia, proteinuria, influenza-like syndrome, fever, pain, nasal complaints, skin reactions, nail disorder, dehydration, edema, chills, hot flushes, abnormally colored urine, depression, hypertension, chest pain, heart attack, renal impairment.

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.

Baratent comes in 30 capsules in one bottle. Each capsule contains 25 mg sunitinib malate (active substance).

Baratent comes in 30 capsules in one bottle. Each capsule contains 50 mg sunitinib malate (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.