Package leaflet: Information for the user

Sorafenib Teva, 200 mg, coated tablets
Sorafenibum
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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Sorafenib Teva is and what it is used for
What you need to know before taking Sorafenib Teva
How to take Sorafenib Teva
Possible side effects
How to store Sorafenib Teva
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) in patients in whom standard therapy has not been effective in halting disease progression or is considered inappropriate.
Sorafenib Teva is used in the treatment of thyroid cancer (differentiated thyroid cancer).
Sorafenib Teva is a so-called multikinase inhibitor. It works by slowing down the growth of cancer cells and cutting off the blood supply that supports the growth of cancer cells.

2. What you need to know before taking Sorafenib Teva

When not to 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
Before starting treatment with Sorafenib Teva, discuss this with your doctor or pharmacist.

When to be cautious when taking Sorafenib Teva

If skin changes occur. Sorafenib Teva may cause rashes and skin reactions, especially on the palms of the hands and soles of the feet. These changes can usually be managed by your doctor. If they do not resolve, your doctor may temporarily interrupt or completely discontinue treatment.
If you have high blood pressure. Sorafenib Teva may increase blood pressure. Your doctor will monitor your blood pressure and may prescribe antihypertensive medications if needed.
If you have or have had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
If you have diabetes. Blood sugar levels should be monitored regularly in patients with diabetes to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of hypoglycaemia.
If any bleeding occurs or if you are taking warfarin or phenprocoumon. Treatment with Sorafenib Teva may increase the risk of bleeding. Patients taking warfarin or phenprocoumon, which reduce blood clotting to prevent thrombosis, may have an increased risk of bleeding.
If you experience chest pain or heart problems, your doctor may decide to interrupt or discontinue treatment with Sorafenib Teva.
If you have heart disorders, such as an abnormal electrical activity known as “QT interval prolongation.”
If you are planning to have surgery or have recently undergone surgery. Sorafenib Teva may affect wound healing. Sorafenib Teva is usually discontinued before surgery. Your doctor will decide when to resume treatment.
If you are also taking irinotecan or receiving docetaxel, which are also anticancer medicines. Sorafenib Teva may enhance their effects, particularly their side effects.
If you are taking neomycin or other antibiotics, the effectiveness of Sorafenib Teva may be reduced.
If you have severe liver dysfunction, more serious side effects may occur during treatment.
In case of impaired kidney function, your doctor will monitor your fluid and electrolyte balance.
Fertility. Sorafenib Teva may reduce fertility in both men and women. Discuss any fertility concerns with your doctor.
Gastrointestinal perforation. A perforation (a hole) in the wall of the digestive tract may occur during treatment (see also section 4: Possible side effects). In such cases, your doctor will recommend discontinuing treatment.
If you have thyroid cancer, your doctor will monitor blood calcium and thyroid hormone levels.
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These symptoms may be caused by a group of metabolic complications that can occur during cancer treatment due to the breakdown products of dying cancer cells [tumour lysis syndrome (TLS)], which may lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).

Please inform your doctor if any of the above conditions apply to you. In such cases, appropriate treatment may be required, and your doctor may decide to adjust the dose of Sorafenib Teva or discontinue treatment altogether (see also section 4: Possible side effects).

Children and adolescents
Studies on the use of Sorafenib Teva in children and adolescents have not been conducted.

Sorafenib Teva and other medicines
Some medicines may affect the action of Sorafenib Teva, or their action may be altered by Sorafenib Teva. Tell your doctor or pharmacist if you are currently or have recently taken, or plan to take, any of the following medicines or any other medicines, including those available without a prescription:

Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
St John’s wort, used in the treatment of depression
Phenytoin, carbamazepine, or phenobarbital, medicines used in epilepsy and other disorders
Dexamethasone, a corticosteroid used in various diseases
Warfarin or phenprocoumon, anticoagulant medicines used to prevent thrombosis
Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan – anticancer medicines
Digoxin, used in the treatment of mild to moderate heart failure

Pregnancy and breastfeeding
You should avoid becoming pregnant while taking Sorafenib Teva. If there is any possibility of pregnancy, you should use an effective method of contraception during treatment.
If you become pregnant while being treated with Sorafenib Teva, contact your doctor immediately. Your doctor will decide whether treatment can be continued.
Do not breastfeed while taking Sorafenib Teva, as sorafenib may affect the growth and development of the child.

Driving and operating machinery
There are no data indicating that sorafenib impairs the ability to drive or operate machinery.

Sorafenib Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is considered “sodium-free”.

3. How to take Sorafenib Teva
The recommended dose of Sorafenib Teva in adults is two 200 mg tablets taken twice daily.
This corresponds to a total daily dose of 800 mg, or four tablets per day.
Sorafenib Teva should be taken with a glass of water, either on an empty stomach or with a low- or moderate-fat meal. Do not take this medicine with high-fat meals, as this may reduce the effectiveness of Sorafenib Teva. If you plan to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
Always take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
It is important to take this medicine at approximately the same time each day to maintain a consistent level of the drug in your bloodstream.
This medicine is usually taken for as long as it provides clinical benefit and as long as the patient does not experience unacceptable side effects.

Taking more Sorafenib Teva than prescribed
Contact your doctor immediately if you (or anyone else) have taken more than the prescribed dose. Taking an excessive amount of Sorafenib Teva may increase the risk or severity of side effects, especially diarrhoea and skin reactions. Your doctor may advise discontinuing treatment.

Missing a dose of Sorafenib Teva
If you miss a dose, take it as soon as you remember. If the time for your next dose is approaching, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed single dose.

4. Possible side effects

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

Very common:
may affect more than 1 in 10 people

diarrhoea
nausea (feeling sick)
feeling weak or tired
pain (including mouth pain, abdominal pain, bone pain, headache, tumour-related pain)
hair loss (alopecia)
redness or pain in the hands or feet (hand-foot syndrome)
itching or rash
vomiting
bleeding (including brain haemorrhage, intestinal wall bleeding, respiratory tract bleeding; haemorrhage)
high blood pressure or periodic increases in blood pressure (hypertension)
infections
loss of appetite (anorexia)
constipation
joint pain (arthralgia)
fever
weight loss
dry skin

Common:
may affect no more than 1 in 10 people

flu-like symptoms
indigestion (dyspepsia)
difficulty swallowing (dysphagia)
inflammation or dryness in the mouth, tongue pain (stomatitis and mucosal inflammation)
low calcium levels in the blood (hypocalcaemia)
low potassium levels in the blood (hypokalaemia)
low blood sugar levels (hypoglycaemia)
muscle pain (myalgia)
sensory disturbances in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
depression
erectile dysfunction (impotence)
voice changes (dysphonia)
acne
skin inflammation symptoms, dry and flaking skin (dermatitis, skin desquamation)
heart failure
heart attack (myocardial infarction) or chest pain
tinnitus (ringing in the ear)
kidney failure
exceptionally high levels of protein in the urine (proteinuria)
general weakness or loss of strength (asthenia)
reduced number of white blood cells (leucopenia and neutropenia)
reduced number of red blood cells (anaemia)
low platelet count (thrombocytopenia)
inflammation of hair follicles (folliculitis)
reduced thyroid activity (hypothyroidism)
low sodium levels in the blood (hyponatraemia)
taste disturbances (dysgeusia)
redness of the face and often other areas of skin (flushing)
watery nasal discharge (watery rhinitis)
heartburn (gastro-oesophageal reflux disease)
skin cancer (squamous cell carcinoma/skin squamous cell carcinoma)
thickening of the outer layer of the skin (hyperkeratosis)
sudden, involuntary muscle spasms (muscle cramps)

Uncommon:
may affect no more than 1 in 100 people

inflammation of the mucous lining of the stomach
abdominal pain caused by inflammation of the pancreas, inflammation of the gallbladder and/or bile ducts
yellowing of the skin or eyes (jaundice) due to high levels of bile pigments (hyperbilirubinaemia)
allergic reactions (including skin reactions and hay fever)
dehydration
breast enlargement (gynaecomastia)
breathing difficulties (lung disease)
rash (eczema)
increased thyroid activity (hyperthyroidism)
various skin eruptions (erythema multiforme)
exceptionally high blood pressure
perforation of the intestinal wall (gastrointestinal perforation)
reversible swelling of the posterior part of the brain, which may be associated with headache, altered consciousness, seizures, and visual disturbances including loss of vision (reversible posterior leukoencephalopathy syndrome)
sudden, severe allergic reaction (anaphylactic reaction)

Rare:
may affect no more than 1 in 1000 people

allergic reaction with skin swelling (e.g. face, tongue), which may cause difficulty in breathing or swallowing (angioedema)
irregular heart rhythm (QT interval prolongation)
liver inflammation, which may cause nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
sunburn-like rash, which may occur on skin previously exposed to radiotherapy, and may be severe in intensity (radiation-induced dermatitis)
severe skin and/or mucosal reactions, including painful blisters and fever, with extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
abnormal breakdown of muscle tissue, which may lead to kidney dysfunction (rhabdomyolysis)
kidney damage causing loss of large amounts of protein (nephrotic syndrome)
inflammation of blood vessels in the skin, which may cause a rash (leucocytoclastic vasculitis)

Unknown:
frequency cannot be estimated from available data

brain function disorders, which may be associated with, for example, drowsiness, changes in behaviour or disorientation (encephalopathy)
enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysm and arterial dissection)
nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine and fatigue [tumour lysis syndrome (TLS)] (see section 2).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps 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 stated on the carton and on each blister
after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine. Store in the
original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect the
environment.

6. Contents of the package and other information

What Sorafenib Teva contains

The active substance is sorafenib. Each coated tablet contains 200 mg of sorafenib (as sorafenib tosylate).
Other components:
Tablet core: microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, hypromellose, magnesium stearate.
Tablet coating: hypromellose, polyethylene glycol, titanium dioxide (E 171), iron oxide red (E 172).

What Sorafenib Teva looks like and contents of the pack
Sorafenib Teva 200 mg film-coated tablets (tablets) are pink, round, biconvex tablets, embossed with "TV" on one side and "S3" on the other side. The tablets are approximately 11 mm in diameter.
Sorafenib Teva is available in blister packs containing 28, 30, 56 and 112 film-coated tablets, and in perforated unit dose blister packs containing 112 x 1 film-coated tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53,
00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturer / Importer
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany
Teva Operations Poland Sp. z o.o.
Mogilska 80, 31-546 Kraków, Poland
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipoviča 25, 10000 Zagreb, Croatia
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjordur, Iceland