Nexavar 200 mg film-coated tablets

Nexavar is used to treat liver cancer ( hepatocellular carcinoma).
Nexavar is also used to treat kidney cancer ( advanced renal cell carcinoma) at an advanced stage when standard therapy has not helped to stop your disease or is considered unsuitable.

Nexavar is a so-called multikinase inhibitor. It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.

Do not take Nexavar

• If you are allergic (hypersensitive) to sorafenib or any of the other ingredients of Nexavar. The ingredients are listed at the end of this leaflet.

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 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 Possible Side Effects, section 4). 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 Nexavar, or stop treatment altogether. See also Possible Side Effects, section 4.

Taking other medicines
Some medicines may affect Nexavar, or be affected by it. Tell your doctor or pharmacist if you are taking anything in this list:

• Rifampicin, Neomycin or other 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 other cancer treatments
• Digoxin, a treatment for mild to moderate heart failure

Tell your doctor or pharmacist if you are taking these or any other medicines (or have taken anything recently) ? even those not prescribed.

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 machinery.

The usual dose of Nexavar in adults is 2x200 mg tablets, twice daily.
This is equivalent to a daily dose of 800 mg or four tablets a day.

Swallow Nexavar tablets with a glass of water, either without food or with a low-fat or moderate fat meal. Do not take this medicine with high fat meals, as this may make Nexavar less effective. If you intend to have a high fat meal take the tablets at least 1 hour before or 2 hours after the meal. Always take Nexavar exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

It is important to take Nexavar at about the same times each day, so that there is a steady amount in the bloodstream.

You will usually carry on taking Nexavar as long as you are getting clinical benefits, and not suffering unacceptable side effects.

If you take more Nexavar than you shouldTell 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 Nexavar.

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.

Use in children

The use of Nexavar in children below the age of 18 years has not been studied.

Like all medicines, Nexavar can cause side effects although not everybody gets them. This medicine may also affect the results of some blood tests.

Very common side effects

(affects more than 1 user in 10)

• diarrhoea
• feeling sick ( nausea)
• feeling weak or tired
• pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain)
• hair loss
• flushing
• flushed or painful palms or soles (hand foot syndrome)
• itching or rash
• throwing up ( vomiting)
• bleeding (including bleeding in the brain, gut wall and respiratory tract; haemorrhage)
• high blood pressure, or increases in blood pressure

Common side effects

( affects 1 to 10 users in 100)

• flu-like illness
• fever
• indigestion
• constipation
• difficulty swallowing
• inflamed or dry mouth, tongue pain
• weight loss
• loss of appetite
• joint or muscle pain ( arthralgia)
• disturbed sensations in fingers and toes, including tingling or numbness
• depression
• erection problems ( impotence)
• hoarseness
• acne
• inflamed, dry or scaly skin that sheds
• heart failure
• tinnitus
• kidney failure

Uncommon side effects

(affects 1 to 10 users in 1,000)

• inflamed stomach lining ( gastritis) and heartburn ( gastrooesophageal reflux disease)
• pain in the tummy ( abdomen) caused by pancreatitis, inflammation of the gall bladder and/or bile ducts
• yellow skin or eyes ( jaundice) caused by high levels of bile pigments ( hyperbilirubinaemia)
• allergic like reactions (including skin reactions and hives)
• infections of hair follicles ( folliculitis)
• general infections
• dehydration
• enlarged breasts
• persistent runny nose
• breathing difficulty ( lung disease)
• eczema
• serious reactions of the skin and/or mucous membranes which may include painful blisters and fever ( Stevens-Johnson syndrome)
• heart attack ( myocardial infarction) or chest pain
• underactive or overactive thyroid
• multiple skin eruptions ( erythema multiforme)
• abnormally high blood pressure
• holes in the gut wall ( gastrointestinal perforation)
• reversible swelling in the rear part of the brain that can be associated with headache, altered consciousness, fits and visual symptoms including visual loss ( reversible posterior leukoencephalopathy)
• benign localised skin growth (keratoacanthoma)/skin cancer

Rare side effects

(affects 1 to 10 users in 10,000)

• abnormal heart rhythm (QT prolongation)

Other side effects

(of which the frequency cannot be estimated from the available data)

• a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe ( radiation recall dermatitis)
• allergic reaction with swelling of the skin (e. g. face, tongue) that may cause difficulty in breathing or swallowing ( angioedema)
• inflammation of the liver, which may lead to nausea, vomiting, abdominal pain, and jaundice ( drug induced hepatitis)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use the tablets after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Nexavar contains

• The active substance is sorafenib. 1 tablet contains 200 mg sorafenib (as tosylate).
• The other ingredients are: Core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate. Coating: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide red (E 172).

What Nexavar looks like and contents of the pack

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

Marketing Authorisation Holder

Bayer Schering Pharma AG
13342 Berlin
Germany

Manufacturer

Bayer Schering Pharma AG
51368 Leverkusen
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. The list of local representatives is located at the end of this leaflet/booklet.

Luxembourg Luxemburg Bayer SA-NV TélTel 32-02-535 63 11 Magyarország Bayer Hungária Kft. Tel.36-14 87-41 00 Malta Alfred Gera and Sons Ltd. Tel 356-21 44 62 05 Nederland Bayer B.V., Bayer Schering Pharma Tel 31-0297-28 06 66 Norge Bayer AS Tlf. 47 24 11 18 00 Österreich Bayer Austria Ges. m. b. H. Tel 43-01-711 46-0 Polska Bayer Sp. z o.o. Tel. 48-22-572 35 00 Portugal Bayer Portugal S.A Tel 351-21-416 42 00 România SC Bayer SRL Tel. 40 21 528 59 00 Slovenija Bayer d. o. o. Tel. 386-1-58 14 400 Slovenská republika Bayer, spol. s r.o. Tel 421 2 59 21 31 11 SuomiFinland Bayer Oy, Bayer Schering Pharma PuhTel 358-20 785 21 Sverige Bayer AB Tel 46-08-580 223 00 United Kingdom Bayer plc Tel 44-01 635-56 30 00 België Belgique Belgien Bayer SA-NV TélTel 32-02-535 63 11 . 359 02 81 401 01 eská republika Bayer s.r.o. Tel 420 266 101 111 Danmark Bayer AS Tlf 45-45 23 50 00 Deutschland Bayer Vital GmbH Tel 49-0214-30 513 48 Eesti Bayer OÜ Tel 372 655 85 65 Bayer 30 210 618 75 00 España Bayer Hispania S.L. Tel 34-93-495 65 00 France Bayer Santé Tél 33-03 28 16 34 00 Ireland Bayer Limited Tel 353 1 299 93 13 Ísland Icepharma hf. Sími 354 540 80 00 Italia Bayer S.p.A. Tel 39-02-397 81 NOVAGEM Limited 357 22 74 77 47 Latvija SIA Bayer Tel 371 67 84 55 63 Lietuva UAB Bayer Tel. 37 05 23 36 868

This leaflet was last approved in {}