Package Leaflet: Information for the User

Sorafenib Teva 200 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you start taking Sorafenib Teva

3. How to take Sorafenib Teva

4. Possible side effects

5. Storage of Sorafenib Teva

6. Contents of the pack and additional information

Sorafenib Teva is used in the treatment of liver cancer (hepatocellular carcinoma).

Sorafenib Teva is also used in the treatment of advanced kidney cancer (advanced renal cell carcinoma) when standard treatment has not been able to slow down the disease or is considered inappropriate.

Sorafenib Teva is used in the treatment of thyroid cancer (differentiated thyroid carcinoma).

Sorafenib is called a multi-tyrosine kinase inhibitor. It acts by slowing down the growth rate of cancer cells and interrupting the blood supply that allows cancer cells to grow.

Do not take Sorafenib Teva

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take sorafenib.

Be especially careful with Sorafenib Teva

• If you experience skin problems. Sorafenib may cause rashes and skin reactions, especially on hands and feet. Your doctor can usually treat these conditions. If not, your doctor may temporarily or completely stop treatment.
• If you have hypertension. Sorafenib may increase blood pressure, and your doctor will usually monitor your blood pressure and may give you a medicine to treat your hypertension.
• If you have or have had an aneurysm(an enlargement and weakening of the wall of a blood vessel)or a tear in the wall of a blood vessel.
• If you have diabetes. Regularly monitor blood sugar levels in diabetic patients to evaluate if the dose of antidiabetic medicine needs to be adjusted to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or fenprocumon. Sorafenib treatment may increase the risk of bleeding. If you are taking warfarin or fenprocumon, medicines that thin the blood to prevent the formation of blood clots, you may have a higher risk of bleeding.
• If you have chest pain or heart problems.Your doctor may decide to temporarily or completely stop treatment.
• If you have a heart disorder,such as an abnormal electrical signal called “prolongation of the QT interval”.
• If you are about to undergo surgery, or have recently had an operation. Sorafenib may affect wound healing. If you are about to undergo surgery, treatment with sorafenib is usually stopped. Your doctor will decide when to restart treatment with sorafenib.
• If you are taking irinotecan or docetaxel,which are also cancer medicines. Sorafenib may increase the effects, and in particular, the adverse effects of these medicines.
• If you are taking neomicin or other antibiotics. The effect of sorafenib may be reduced.
• If you have severe liver failure.You may experience more severe side effects when taking this medicine.
• If you have kidney failure. Your doctor will monitor your fluid balance and electrolytes.
• Fertility. Sorafenib may reduce fertility in both men and women. If this applies to you, talk to your doctor.
• During treatment, perforations in the intestinal wall(gastrointestinal perforation)may occur (see section 4: Possible side effects). In this case, your doctor will stop treatment.
• If you have thyroid cancer. Your doctor will monitor blood calcium and thyroid hormone levels.
• If you experience the following symptoms,contact your doctor immediately, as it may be a potentially life-threatening situation: nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, and fatigue. The cause may be a set of metabolic complications that may occur during cancer treatment as a result of the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may cause changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Inform your doctor if any of these affect you.You may need treatment for them, or your doctor may decide to change your sorafenib dose or stop treatment completely (see also section 4: Possible side effects).

Children and adolescents

No clinical trials have been conducted with sorafenib in children and adolescents.

Other medicines and Sorafenib Teva

Some medicines may affect sorafenib, or may be affected by it. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine from this list or any other medicine, including those bought without a prescription.

• Rifampicin, neomicin, or other medicines used to treat infections(antibiotics)
• St. John's Wort, a herbal remedy fordepression
• Phenobarbital, carbamazepine, or phenytoin, treatments forepilepsyand other diseases
• Dexamethasone, acorticosteroidused for various diseases
• Warfarin or fenprocumon, anticoagulants used toprevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, forcancer treatment
• Digoxin, a treatment formild to moderate heart failure.

Pregnancy and breastfeeding

Avoid becoming pregnant while being treated with sorafenib. If you can become pregnant, use an appropriate contraceptive method during treatment. If you become pregnant while being treated with sorafenib, inform your doctor immediately, who will decide whether to continue treatment.

Do not breastfeed during treatment with sorafenib, as this medicine may interfere with the growth and development of your baby.

Driving and operating machines

There is no evidence that sorafenib can affect your ability to drive or operate machines.

Sorafenib Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially “sodium-free”.

The recommended dose of Sorafenib Teva in adults is 2 tablets of 200 mg, taken twice a day.

This is equivalent to a daily dose of 800 mg or four tablets a day.

Swallow Sorafenib Teva tablets with a glass of water, without food or with a low or moderate fat meal. Do not take this medication with a high-fat meal, as this reduces the efficacy of sorafenib. If you plan to take a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again..

It is essential to take this medication at the same time every day, so that there is a constant amount in the bloodstream.

Normally, you will continue taking this medication as long as it provides clinical benefits and you do not experience unacceptable side effects.

If you take more Sorafenib Teva than you should

Inform your doctor immediatelyif you (or someone) has taken more than the prescribed dose. Taking too much sorafenib increases the likelihood of side effects or that they will be more severe, especially diarrhea and skin reactions. Your doctor may instruct you to stop taking this medication.

If you accidentally take too many sorafenib tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Sorafenib Teva

If you have forgotten a dose, take it as soon as you remember. If it is close to the time of the next dose, do not take the missed dose and continue normally. Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. This medicine may also affect the results of some blood tests.

Very common:

may affect more than 1 in 10 people

• diarrhea
• feeling of dizziness (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss (alopecia)
• red or painful palms and soles of the feet (hand-foot reaction)
• itching or rash
• vomiting
• bleeding (including brain hemorrhage, intestinal wall hemorrhage, and respiratory tract hemorrhage)
• high blood pressure, or increased blood pressure (hypertension)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain (arthritis)
• fever
• weight loss
• dry skin

Common:

may affect up to 1 in 10 people

• flu-like illness
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• dry or inflamed mouth, tongue pain (stomatitis and mucosal inflammation)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar (hypoglycemia)
• muscle pain (myalgia)
• peripheral sensory neuropathy, including tingling or numbness in the fingers and toes
• depression
• erectile dysfunction (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin peeling)
• heart failure
• heart attack (myocardial infarction) and chest pain
• tinnitus (ringing in the ears)
• kidney failure
• abnormally high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• decreased white blood cell count (leukopenia and neutropenia)
• decreased red blood cell count (anemia)
• low platelet count in the blood (thrombocytopenia)
• inflammation of the hair follicles (folliculitis)
• hypothyroidism (low thyroid function)
• low sodium levels in the blood (hyponatremia)
• alteration of taste (dysgeusia)
• flushing of the face and often other parts of the skin (flushing)
• nasal discharge (rhinorrhea)
• acid reflux (gastroesophageal reflux disease)
• skin cancer (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 wall (gastritis)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder and/or bile ducts
• yellowing of the skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinemia)
• allergic reactions (including skin reactions and urticaria)
• dehydration
• breast enlargement (gynecomastia)
• difficulty breathing (pulmonary disease)
• eczema
• hyperthyroidism (overactive thyroid)
• multiple skin eruptions (erythema multiforme)
• abnormally high blood pressure
• gastrointestinal perforation
• reversible inflammation in the back of the brain that may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (posterior reversible encephalopathy 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) that may cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (prolonged QT interval)
• inflammation of the liver, which may cause nausea, vomiting, abdominal pain, and yellowing of the skin (jaundice) (drug-induced hepatitis)
• a skin eruption similar to sunburn on previously irradiated skin that may be severe (radiation recall dermatitis)
• severe skin and/or mucous membrane reactions that may include painful blisters and fever, including extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle degradation that may lead to kidney problems (rhabdomyolysis)
• kidney damage that causes the loss of large amounts of protein (nephrotic syndrome)
• inflammation of blood vessels in the skin that may cause a rash (leukocytoclastic vasculitis)

Frequency not known:

the frequency cannot be estimated from the available data

• brain damage that may be associated with, for example, drowsiness, changes in behavior, or confusion (encephalopathy)
• aneurysm or arterial dissection (e.g. aneurysm or arterial dissection)
• nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, and fatigue (tumor lysis syndrome [TLS] (see section 2).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration datethat appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSorafenib Teva

• The active ingredient is sorafenib. Each film-coated tablet contains 200 mg (as tosilate).
• The other excipients are:
• Core of the tablet:microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, hypromellose, magnesium stearate (vegetal)
• Coating of the tablet: hypromellose, macrogol, titanium dioxide (E171), iron oxide red (E172)

Appearance of the product and content of the package

Sorafenib Teva 200 mg film-coated tablets are pink, round, biconvex, and engraved with “TV” on one side and “S3·” on the other. The tablets have approximately 11 mm in diameter.

Sorafenib Teva is available in blister packs containing 28, 30, 56, and 112 film-coated tablets and in perforated single-dose blisters containing 112 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabael Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid),

Spain

Responsible for manufacturing

PLIVA Hrvatska d.o.o.

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

or

Merckle GmbH

Ludwig-Merckle Strasse 3

Blaubeuren, 89143

Germany

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80,

Cracovia, 31-546,

Poland

or

Teva Pharma B.V.,

Swensweg 5,

Haarlem, 2031GA,

Netherlands

or

Actavis Group PTC ehf.

Dalshraun 1,

220 Hafnarfjordur

Island

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany:Sorafenib-AbZ 200 mg Filmtabletten

Belgium:Sorafenib Teva 200 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Bulgaria:????????? ???? 200 mg ????????? ???????? Sorafenib Teva 200 mg film-coated tablets

Croatia:Sorafenib Teva 200 mg filmom obložene tablete

Denmark:Sorafenib Teva

Slovakia:Sorafenib Teva

Slovenia:Sorafenib Teva 200 mg filmsko obložene tablete

Spain:Sorafenib Teva 200 mg comprimidos recubiertos con película EFG

Estonia:Sorafenib Teva

Finland:Sorafenib ratiopharm 200 mg tabletti, kalvopäällysteinen

France:SORAFENIB TEVA 200 mg, comprimé pelliculé

Greece:Sorafenib/Teva 200 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Hungary:Sorafenib Teva 200 mg filmtabletta

Italy:Sorafenib Teva

Lithuania:Sorafenib Teva 200 mg plevele dengtos tabletes

Latvia:Sorafenib Teva 200 mg apvalkotas tabletes

Luxembourg:Sorafenib Teva200 mg comprimés pelliculés

Netherlands:Sorafenib Teva 200 mg, filmomhulde tabletten

Poland:Sorafenib Teva

Portugal:Sorafenib Teva

Czech Republic:Sorafenib Teva

United Kingdom (Northern Ireland): Sorafenib Teva 200 mg film-coated tablets

Sweden:Sorafenib Teva

Last review date of this leaflet:September 2024

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es