• 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).

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

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

Talk to your doctor or pharmacist before taking Sorafenib

• If you experience the following symptoms, contact your doctor immediately as this can be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness. These may be caused by a group of metabolic complications that can occur during treatment of cancer that are caused by the break-down products of dying cancer cells (Tumour lysis syndrome (TLS)) and can lead to changes in kidney function and acute renal failure (see also section 4: Possible side effects).
• If you experience skin problems as Sorafenib 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 as Sorafenib 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 Sorafenib 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 as Sorafenib might affect the way your wounds heal. You will usually be taken off this medicine if you are having an operation.
  Your doctor will decide when to start with Sorafenib again.
• If you are taking irinotecan or are given docetaxel, which are also medicines for cancer.
  Sorafenib may increase the effects and, in particular, the side effects of these medicines.
• If you are taking Neomycin or other antibiotics. The effect of Sorafenib 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. This medicine 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 if any of these affect you. You may need treatment for them, or your doctor may decide to change your dose of Sorafenib, or stop treatment altogether (see also section 4: Possible side effects).

Children and adolescents have not yet been tested with Sorafenib

Some medicines may affect Sorafenib 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

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

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

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

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

Tell your doctor straight away if you (or anyone else) have taken more than your prescribed dose. Taking too much Sorafenib 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 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 a forgotten dose.

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 via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is sorafenib. Each film-coated tablet contains 200 mg sorafenib (as tosylate).
• The other ingredients are:

Tablet core: hypromellose 2910 (E464), croscarmellose sodium (E468), cellulose, microcrystalline (E460), magnesium stearate (E470b), sodium laurilsulfate (E514).

Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172).

Sorafenib 200 mg film-coated tablets are red-brown, round, biconvex film-coated tablets debossed with “200” on one side and plain on the other side with a diameter of tablet 12.0 mm ± 5%.

They come in packs of 112 film-coated tablets in Aluminium-PVC/PE/PVDC blisters or 112 x 1 film-coated tablets in Aluminium-PVC/PE/PVDC perforated unit dose blisters.

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