Sorafenib Teva

Package leaflet: Information for the user

Sorafenib Teva 200 mg film-coated tablets

sorafenib
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Sorafenib Teva is and what it is used for

Sorafenib Teva is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Teva is also used to treat advanced kidney cancer (advanced renal cell carcinoma)
when standard therapy has not helped to stop the disease or is considered unsuitable.
Sorafenib Teva is a so-called multikinase inhibitor. It works by slowing down the rate of
tumour cell growth and by blocking the blood supply that allows tumour cells to grow.

2. What you should know before taking Sorafenib Teva

Do not take Sorafenib Teva

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Sorafenib Teva.
Exercise special caution with Sorafenib Teva

• If you develop skin problems. Sorafenib Teva can cause rashes and skin reactions, especially on the hands and feet. These effects can usually be managed by your doctor. Otherwise, your doctor may suspend or completely stop treatment.
• If you have high blood pressure. Sorafenib Teva can cause an increase in blood pressure; your doctor will monitor your blood pressure regularly and may prescribe medication to treat high blood pressure.
• If you have or have had an aneurysm (a swelling and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have diabetes. Blood sugar levels should be monitored regularly in diabetic patients to assess whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycemia.
• If you have bleeding problems or if you are taking warfarin or fenprocoumon. Treatment with Sorafenib Teva may increase the risk of bleeding. If you are taking warfarin or fenprocoumon, medicines that thin the blood to prevent blood clots, there may be an increased risk of bleeding.
• If you have chest pain or heart problems. Your doctor may decide to suspend or completely stop treatment.
• If you have a heart condition, for example, an electrical signaling disorder called “QT interval prolongation”.
• If you are about to undergo or have recently undergone surgery. Sorafenib Teva may affect wound healing. If you are scheduled for surgery, treatment with Sorafenib Teva will likely be stopped. Your doctor will decide when to restart it.
• If you are being treated with irinotecan or docetaxel, which are also anticancer medicines. Sorafenib Teva may increase the effects, and particularly the side effects, of these medicines.
• If you are taking neomycin or other antibiotics. The effect of Sorafenib Teva may be reduced.
• If you have severe liver impairment. You may experience more severe side effects during treatment with this medicine.
• If you have reduced kidney function. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. Sorafenib Teva may reduce fertility in both men and women. If you are concerned, discuss this with your doctor.
• Gastrointestinal perforations (see section 4: Possible side effects) may occur during treatment. In such cases, your doctor will suspend treatment.

Inform your doctor if any of these conditions apply to you. You may need additional treatment or your doctor may decide to adjust the dose of Sorafenib Teva or stop treatment altogether (see also section 4: Possible side effects).
Children and adolescents
Sorafenib Teva has not been studied in children and adolescents.
Other medicines and Sorafenib Teva
Some medicines may affect or be affected by Sorafenib Teva. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed below or any other medicine, including those not requiring a prescription:

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

Pregnancy and breastfeeding
Avoid becoming pregnant while being treated with Sorafenib Teva. If you are of childbearing age, use an effective method of contraception during treatment. If you become pregnant while taking Sorafenib Teva, contact your doctor immediately, who will decide whether to continue or stop treatment.
You must not breastfeed during treatment with Sorafenib Teva, as this medicine may interfere with the growth and development of the infant.
Driving and using machines
There are no known reasons to believe that sorafenib may affect the ability to drive vehicles or operate machinery.
Sorafenib Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Sorafenib Teva

The recommended dose of Sorafenib Teva in adults is 2 tablets of 200 mg twice daily.
This corresponds to a daily dose of 800 mg or four tablets per day.
Take Sorafenib Teva tablets with a glass of water, on an empty stomach or with a meal low or moderate in fat. Do not take this medicine with high-fat meals, as they may reduce its effectiveness. If you plan to consume a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
It is important to take this medicine at approximately the same time each day to maintain a constant concentration in the blood.
This medicine is usually taken for as long as clinical benefit is observed and unacceptable side effects do not occur.
If you take more Sorafenib Teva than you should
Inform your doctor immediately if you, or anyone else, have taken more than the prescribed dose.
Taking too much Sorafenib Teva makes side effects more likely or more severe, especially diarrhea and skin reactions. Your doctor may ask you to stop taking this medicine.
If you forget to take Sorafenib Teva
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine may also alter the results of certain blood tests.

Very common:
may affect more than 1 in 10 people

• diarrhoea
• feeling unwell (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth, abdominal pain, headache, bone pain, cancer-related pain)
• hair loss (alopecia)
• redness or pain on the palms of the hands or soles of the feet (hand-foot skin reaction)
• itching or rash
• vomiting
• bleeding (including brain haemorrhage, intestinal wall bleeding, respiratory tract bleeding; haemorrhage)
• high blood pressure or increased blood pressure (hypertension)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain (arthralgia)
• fever
• weight loss
• dry skin

Common:
may affect up to 1 in 10 people

• flu-like illness
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness of the mouth, tongue pain (stomatitis and mucosal inflammation)
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• low levels of blood sugar (hypoglycaemia)
• muscle pain (myalgia)
• sensory disturbances in fingers and toes, including tingling and numbness (peripheral sensory neuropathy)
• depression
• erection problems (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry or peeling skin (dermatitis, skin desquamation)
• heart failure
• heart attack (myocardial infarction) or chest pain
• tinnitus (ringing in the ears)
• kidney failure
• unusually high levels of protein in the urine (proteinuria)
• generalised weakness or lack of energy (asthenia)
• reduced number of white blood cells (leucopenia and neutropenia)
• reduced number of red blood cells (anaemia)
• low number of platelets in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• reduced thyroid activity (hypothyroidism)
• low levels of sodium in the blood (hyponatraemia)
• changes in taste sensation (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinorrhoea)
• heartburn (gastro-oesophageal reflux disease)
• skin tumour (keratoacanthoma/squamous cell carcinoma)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden involuntary muscle contractions (muscle spasms)

Uncommon:
may affect up to 1 in 100 people

• inflammation of the stomach lining (gastritis)
• stomach ache (abdominal pain) due to pancreatitis, inflammation of the gallbladder and/or bile ducts
• yellowing of the skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia)
• allergic-type reactions (including skin reactions and urticaria)
• dehydration
• breast enlargement (gynaecomastia)
• difficulty breathing (lung disease)
• eczema
• overactivity of the thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• unusually high blood pressure
• gastrointestinal perforation
• reversible swelling in the back part of the brain which may be associated with headache, altered consciousness, seizures and visual symptoms, including vision loss (reversible posterior leucoencephalopathy syndrome)
• severe and sudden allergic reactions (anaphylactic reaction)

Rare:
may affect up to 1 in 1,000 people

• allergic reaction with skin swelling (e.g. face, tongue) which may cause difficulty in breathing and swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• liver inflammation, which may cause nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
• appearance of a sunburn-like rash on skin previously exposed to radiotherapy, potentially severe (radiation recall dermatitis)
• severe skin and/or mucosal reactions which may include painful blisters and fever, with shedding of large areas of skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle damage which may lead to kidney problems (rhabdomyolysis)
• kidney damage causing loss of large amounts of protein in the urine (nephrotic syndrome)
• inflammation of blood vessels in the skin which may appear as a rash (leucocytoclastic vasculitis)

Frequency not known:
frequency cannot be estimated from the available data

• impaired brain function which may, for example, be associated with drowsiness, behavioural changes or confusion (encephalopathy)
• dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sorafenib Teva

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." and on
each blister after "EXP." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions with regard to temperature.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sorafenib Teva contains

• The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The other components are: Tablet core: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hypromellose, magnesium stearate [vegetable]. Tablet coating: hypromellose, macrogol, titanium dioxide (E171), and red iron oxide (E172).

Description of the appearance of Sorafenib Teva and contents of the pack
Sorafenib Teva 200 mg film-coated tablets are pink, round, biconvex tablets, marked “TV” on one side and “S3” on the other. The tablets are approximately 11 mm in diameter.
Sorafenib Teva is available in blisters containing 28, 30, 56, and 112 film-coated tablets, and in unit-dose perforated blisters containing 112 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturer
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.), Prilaz baruna Filipovića 25, Zagreb, 10000 – Croatia
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143 – Germany
Teva Operations Poland Sp. z o.o, ul. Mogilska 80, Kraków, 31-546 – Poland
Teva Pharma B.V., Swensweg 5, Haarlem, 2031GA – The Netherlands