Regafib 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 Regafib.

Take special care with Regafib:

- If you have any liver problems.

- If you get an infection.

- If you get severe stomach and bowel problems.

- If you have any cardiovascular problems, chest pain, high blood pressure or bleeding problems

- If you develop a severe and persistent headache, visual disturbances, seizures or altered mental status.

- If you recently had or are going to have a surgical procedure.

- If you experience skin problems.

- 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:

Regafib 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.

Both women of childbearing potential and men should use effective contraception during treatment and for at least eight weeks after completion of treatment.

Children and adolescents:

There is no relevant use of Regafib in children and adolescents.

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 Regorafenib.

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

Swallow the tablet whole with water after a light meal that contains less than 30% fat at the same time each day.

If you have accidentally taken too many tablets, 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:

Reduction in the number blood cells, high blood pressure, heart attack, anemia, electrolyte imbalance, dry mouth, mouth sores, decreased appetite, diarrhea, stomatitis, nausea, vomiting, hyperbilirubinemia, liver disorders, weight loss, weakness, headache, fever, increased risk of infection, skin reactions, nail disorder, hypothyroidism, tremor, pain, taste altered, hair loss, proteinuria.

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.

Regafib comes in 28 tablets in one bottle. Each tablet contains 40 mg Regorafenib (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.