Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Nexavar is and what it is used for
2. What you need to know before you take Nexavar
3. How to take Nexavar
4. Possible side effects
5. How to store Nexavar
6. Contents of the pack and other information

Do not take Nexavar

• If you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nexavar.

Take special care with Nexavar

• If you experience skin problems. Nexavar 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. Nexavar can raise blood pressure, and your doctor will usually monitor your blood pressure and may give you a medicine to treat your high blood pressure.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• If you have diabetes. Blood sugar levels in diabetic patients should be checked regularly in order to assess if anti-diabetic medicine’s dosage needs to be adjusted to minimize the risk of low blood sugar.
• If you get any bleeding problems, or are taking warfarin or phenprocoumon. Treatment with Nexavar may lead to a higher risk of bleeding. If you are taking warfarin or phenprocoumon, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
• If you get chest pain or heart problems. Your doctor may decide to interrupt treatment or stop it altogether.
• If you have a heart disorder, such as an abnormal electrical signal called "prolongation of the QT interval".
• If you are going to have surgery, or if you had an operation recently. Nexavar might affect the way your wounds heal. You will usually be taken off Nexavar if you are having an operation. Your doctor will decide when to start with Nexavar again.
• If you are taking irinotecan or are given docetaxel, which are also medicines for cancer. Nexavar may increase the effects and, in particular, the side effects of these medicines.
• If you are taking Neomycin or other antibiotics. The effect of Nexavar may be decreased.
• If you have severe liver impairment. You may experience more severe side effects when taking this medicine.
• If you have poor kidney function. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. Nexavar 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.
• If you have thyroid cancer. Your doctor will monitor blood calcium and thyroid hormone levels.

Tell your doctor if any of these affect you. You may need treatment for them, or your doctor may decide to change your dose of Nexavar, or stop treatment altogether (see also section 4: Possible side effects).

Children and adolescents

Children and adolescents have not yet been tested with Nexavar.

Other medicines and Nexavar

Some medicines may affect Nexavar, or be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken or might take anything in this list or any other medicines, including medicines obtained without a prescription:

• Rifampicin, Neomycin or other medicines used to treat infections (antibiotics)
• St John’s wort, a herbal treatment for depression
• Phenytoin, carbamazepine or phenobarbital, treatments for epilepsy and other conditions
• Dexamethasone, a corticosteroid used for various conditions
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, which are cancer treatments
• Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breast-feeding

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

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

Driving and using machines

There is no evidence that Nexavar will affect the ability to drive or to operate machines.

Nexavar contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.

If you take more Nexavar than you should

Tell your doctor straight away if you (or anyone else) have taken more than your prescribed dose. Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions. Your doctor may tell you to stop taking this medicine.

If you forget to take Nexavar

If you have missed a dose, take it as soon as you remember. If it is nearly time for the next dose, forget about the missed one and carry on as normal. Do not take a double dose to make up for forgotten individual doses.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

Malta

What Nexavar contains

• The active substance is sorafenib. Each film-coated tablet contains 200 mg sorafenib (as tosylate).
• The other ingredients are:
  Tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate.
  Tablet coating: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide red (E 172).

What Nexavar looks like and contents of the pack

Nexavar 200 mg film-coated tablets are red and round with the Bayer cross on one side and “200” on the other side. They come in calendar packs of 112 tablets: four transparent blister packs of 28 tablets each.

Marketing Authorisation Holder

Manufacturer