Sorafenib 200 mg Film-Coated Tablets

SORAFENIB 200 DRL 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. SORAFENIB 200 DRL tablets are used for the treatment of patients with advanced kidney cancer (renal cell carcinoma). SORAFENIB 200 DRL are used for the treatment of patients with advanced inoperable liver cancer (hepatocellular carcinoma). SORAFENIB 200 DRL tablets are used for the treatment of patients with thyroid cancer (differentiated thyroid carcinoma).

Do not take SORAFENIB 200 DRL:

• If you are hypersensitive (allergic) to sorafenib or any of the ingredients of SORAFENIB 200 DRL (listed in section 6).
• If you are a pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before using SORAFENIB 200 DRL.

Take special care with SORAFENIB 200 DRL:

• If you experience skin problems. SORAFENIB 200 DRL 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. SORAFENIB 200 DRL 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 200 DRL 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. SORAFENIB 200 DRL might affect the way your wounds heal. You will usually be taken off SORAFENIB 200 DRL if you are having an operation. Your doctor will decide when to start with SORAFENIB 200 DRL again.
• If you are elderly. Your doctor may consider monitoring your kidney function.
• If you are taking irinotecan or are given docetaxel, which are also medicines for cancer. SORAFENIB 200 DRL 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 200 DRL 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. SORAFENIB 200 DRL 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 SORAFENIB 200 DRL, or stop treatment altogether (see also section 4: Possible side effects).

Do not share medicines prescribed for you with any other person. Always take SORAFENIB 200 DRL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended daily dose of SORAFENIB 200 DRL in adults is 2 tablets taken twice a day, either without food or together with a low fat or moderate fat meal. Do not take SORAFENIB 200 DRL with high fat meals, as this may make SORAFENIB 200 DRL less effective. The tablet is taken orally with a glass of water. The tablets should be swallowed whole with a glass of fluid; under no circumstances should they be bitten, chewed or broken up. It is important to take this medicine at about the same times each day, so that there is a steady amount in the bloodstream. As far as possible, the treatment should be adapted according to the severity of your condition and your response. Do not change the dose prescribed by your doctor. You will usually carry on taking SORAFENIB 200 DRL as long as you are getting clinical benefits, and not suffering unacceptable side effects. Your doctor will tell you how long your treatment with SORAFENIB 200 DRL will last. You should not take SORAFENIB 200 DRL for longer than absolutely necessary.

If you take more SORAFENIB 200 DRL than you should

Tell your doctor straight away if you have taken more than your prescribed dose. Taking too much SORAFENIB 200 DRL makes side effects more likely or more severe, especially diarrhoea and skin reactions.

If you forget to take SORAFENIB 200 DRL

If you missed a dose, do not take more SORAFENIB 200 DRL tablets next time; simply continue the treatment as prescribed. Do not take a double dose to make up for the missed dose.

What should you do if you want to interrupt the treatment or stop using SORAFENIB 200 DRL before the end of the course

Do not interrupt the course of treatment or stop taking SORAFENIB 200 altogether unless you have discussed this with your doctor.

SORAFENIB 200 DRL can have side effects. Not all side effects reported for SORAFENIB 200 DRL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SORAFENIB 200 DRL, please consult your health care provider for advice. If any of the following happens, stop taking SORAFENIB 200 DRL and tell your doctor immediately or go to the casualty department at your nearest hospital:

Less frequent:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to SORAFENIB 200 DRL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent:

• heart attack (myocardial infarction) or chest pain
• bleeding (including bleeding in the brain, gut wall and respiratory tract; haemorrhage)
• high blood pressure, or increases in blood pressure (hypertension)

Less frequent:

• abnormally high blood pressure
• inflammation of the liver, which may lead to nausea, vomiting, abdominal pain, and jaundice (drug induced hepatitis)
• serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)

These are all serious side effects. You may need urgent medical attention.

Tell your doctor or pharmacist if you notice any of the following, especially if they continue, are severe or bother you:

Frequent:

• diarrhoea
• feeling sick (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain)
• hair loss (alopecia)
• flushed or painful palms or soles (hand foot skin reaction)
• itching or rash
• throwing up (vomiting)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain (arthralgia)
• fever
• weight loss
• dry skin
• flu-like illness
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation)

Less frequent:

• low calcium levels in the blood (hypocalcaemia)
• low potassium levels in the blood (hypokalaemia)
• low blood sugar level (hypoglycaemia)
• muscle pain (myalgia)
• disturbed sensations in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• erection problems (impotence)
• altered voice (dysphonia)
• acne
• inflamed, dry or scaly skin that sheds (dermatitis, skin desquamation)
• heart failure
• tinnitus (ringing sound in the ear)
• kidney failure
• abnormally high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• decrease in the number of white blood cells (leucopenia and neutropenia)
• decrease in the number of red blood cells (anaemia)
• low number of platelets in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• underactive thyroid gland (hypothyroidism)
• low sodium levels in the blood (hyponatraemia)
• distortion of the sense of taste (dysgeusia)

Less frequent:

• red in the face and often other areas of the skin (flushing)
• runny nose (rhinorrhoea)
• heartburn (gastro oesophageal reflux disease)
• skin cancer (keratoacanthomas/squamous cell cancer of the skin)
• a thickening of the outer layer of the skin (hyperkeratosis)
• a sudden, involuntary contraction of a muscle (muscle spasms)

Frequency not known:

• impaired brain function that can be associated with e.g. drowsiness, behavioural changes, or confusion (encephalopathy)
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).

If you notice any other side-effects not mentioned in this leaflet, please inform your doctor or your pharmacist.

Store at or below 25 °C. Keep blisters in the outer carton until required for use. This medicine does not require any special storage conditions. Do not store in a bathroom. Do not dispose medicines in drains or sewerage systems (e.g. toilets). Do not use after the expiry date stated on the carton. Store all medicines out of reach of children.