Nexofenib 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 or pharmacist before taking Nexofenib.

Take special care with Nexofenib: 

- If you experience skin problems. Nexofenib can cause rashes and skin reactions, especially on the hands and feet. These can usually be treated by your doctor. If not, your doctor may interrupt treatment or stop it altogether.

- If you have high blood pressure, diabetes, severe liver impairment, poor kidney function.

- If you have chest pain or heart problems.

- If you get any bleeding problems or are taking warfarin or phenprocoumon.

- If you are going to have surgery or if you had an operation recently. Nexofenib might affect the way your wounds heal.

- If you are taking irinotecan or are given docetaxel, which are also medicines for cancer. Nexofenib may increase the effects and in particular, the side effects of these medicines.

- If you are taking Neomycin or other antibiotics. The effect of Nexofenib may be decreased.

- Fertility. Nexofenib may reduce fertility in both men and women. If you are concerned, talk to a doctor.

- Holes in the gut wall (gastrointestinal perforation) may occur during treatment (see section 4: Possible side effects). In this case your doctor will interrupt the treatment.

- 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) and chemical or herbal medicines.

Children and adolescents:

Children and adolescents have not yet been tested with Nexofenib.

Pregnancy and breast-feeding:

Avoid becoming pregnant while being treated with Nexofenib. If you could become pregnant use adequate contraception during treatment. If you become pregnant while being treated with Nexofenib, immediately tell your doctor who will decide if the treatment should be continued.

You must not breast-feed your baby during Nexofenib treatment, as this medicine may interfere with the growth and development of your baby.

Contraindications:

- If you are allergic to sorafenib.

- Use in combination with carboplatin and paclitaxel in patients with squamous cell lung cancer.

Always take this medicine exactly as your doctor or pharmacist has told you.

Do not stop taking Nexofenib unless your doctor tells you to.

Take Nexofenib without high fat meal (at least 1 hour before or 2 hours after the meal) and full glass of water.

Tell your doctor straight away if you have taken more than your prescribed dose.

If you forget a dose, take it as soon as you remember. If it is nearly time for the next dose, skip the missed dose.

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:

Diarrhea, nausea and vomiting, fatigue and weakness, pain, hair loss, flushed or painful palms or soles (hand foot skin reaction), itching or rash, bleeding, hypertension, infections, loss of appetite, constipation, fever, weight loss, dry skin, indigestion, difficulty swallowing, inflamed or dry mouth, low calcium levels in the blood, low potassium levels in the blood, low sodium levels in the blood, low blood sugar level, disturbed sensations in fingers and toes, depression, erection problems, altered voice, acne, inflamed or scaly skin that sheds, heart failure, heart attack or chest pain, tinnitus, kidney failure, abnormally high levels of protein in the urine, decrease in the number of red blood cells and white blood cells and platelets, inflammation of hair follicles, hypothyroidism, distortion of the sense of taste, flushing, runny nose, heartburn, skin cancer, a thickening of the outer layer of the skin, muscle spasms.

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 this medicine above 25°C. Store in the original package in order to protect from moisture.

Nexofenib comes in 30 tablets in one box.

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.