Sorafenib Teva 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sorafenib Teva 200 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. 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 in the treatment of liver cancer (hepatocellular carcinoma).

Sorafenib Teva is also used in the treatment of advanced renal cell cancer (advanced renal cell carcinoma) when standard treatment has not been effective in controlling the disease or is considered inappropriate.

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

Sorafenib is a so-called multikinase inhibitor. It works by slowing down the growth rate of cancer cells and interrupting the blood supply that supports the growth of cancer cells.

2. What you need to know before starting to take 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 starting to take sorafenib.

Take special care with Sorafenib Teva

• If you experience skin problems. Sorafenib may cause rashes and skin reactions, especially on the hands and feet. Your doctor can usually manage these conditions. If not, your doctor may temporarily or completely interrupt treatment.
• If you have high blood pressure (hypertension). Sorafenib may increase blood pressure, and your doctor will usually monitor your blood pressure and may prescribe medication to treat your hypertension.
• If you have or have had an aneurysm (a bulge and weakening in 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 regularly monitored in diabetic patients to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of low blood sugar levels.
• If you have bleeding disorders or are taking warfarin or fenprocoumon. Treatment with sorafenib may increase the risk of bleeding. If you are taking warfarin or fenprocoumon, which are blood-thinning medicines used to prevent blood clots, you may have an increased risk of bleeding.
• If you have chest pain or heart problems. Your doctor may decide to temporarily or completely interrupt treatment.
• If you have a heart disorder, such as an abnormal electrical signal known as “QT interval prolongation.”
• If you are scheduled for surgery or have recently undergone surgery. Sorafenib may affect wound healing. If you are undergoing surgery, sorafenib treatment is usually stopped. Your doctor will decide when to restart sorafenib treatment.
• 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 neomycin or other antibiotics. The effect of sorafenib may be reduced.
• If you have severe liver impairment. You may experience more severe adverse effects when taking this medicine.
• If you have kidney impairment. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. Sorafenib may reduce fertility in both men and women. If this applies to you, speak with your doctor.
• During treatment, holes in the intestinal wall (gastrointestinal perforation) may occur (see section 4: Possible side effects). In such a case, your doctor will stop treatment.
• If you have thyroid cancer. Your doctor will monitor your blood levels of calcium and thyroid hormones.
• If you experience the following symptoms, contact your doctor immediately, as they may indicate a potentially life-threatening condition: nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. This may be due to a group of metabolic complications that can occur during cancer treatment as a result of breakdown products from dying cancer cells [tumor lysis syndrome (TLS)], which may lead to changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

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

Children and adolescents

Sorafenib has not yet been studied 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 recently taken, or might need to take any other medicine from this list or any other medicine, including those obtained without 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 conditions
• Warfarin or fenprocoumon, anticoagulants used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, used for cancer treatment
• Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant while being treated with sorafenib. If you are able to become pregnant, use an effective method of contraception during treatment. If you become pregnant while being treated with sorafenib, inform your doctor immediately; your doctor will decide whether to continue treatment.

You must not breastfeed during treatment with sorafenib, as this medicine may interfere with your baby’s growth and development.

Driving and using machines

There is no evidence that sorafenib affects the ability to drive 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 is equivalent to a daily dose of 800 mg or four tablets per day.

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

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

It is important to take this medicine at the same time each day, so that there is a constant level in the bloodstream.

You will usually continue taking this medicine for as long as it provides clinical benefit and you do not experience unacceptable adverse effects.

If you take more Sorafenib Teva than you should

Inform your doctor immediately if you (or someone else) have taken more than the prescribed dose. Taking too much sorafenib increases the likelihood of adverse effects or makes them more severe, especially diarrhea and skin reactions. Your doctor may instruct you to stop taking this medicine.

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 at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sorafenib Teva

If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

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

Very common:

may affect more than 1 in 10 people

• diarrhea
• feeling sick (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain)
• hair loss (alopecia)
• red or painful palms and soles of the feet (hand-foot skin reaction)
• itching or rash
• vomiting
• bleeding (including brain hemorrhage, intestinal wall and respiratory tract hemorrhage, hemorrhage)
• high blood pressure, or increase in 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)
• dry or inflamed mouth, sore tongue (stomatitis and mucosal inflammation)
• low levels of calcium in the blood (hypocalcemia)
• low levels of potassium in the blood (hypokalemia)
• low levels of blood sugar (hypoglycemia)
• muscle pain (myalgia)
• altered sensation in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• depression
• erection problems (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin desquamation)
• 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)
• decrease in the number of white blood cells (leukopenia and neutropenia)
• decrease in the number of red blood cells (anemia)
• low number of platelets in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• reduced activity of the thyroid gland (hypothyroidism)
• low levels of sodium in the blood (hyponatremia)
• altered sense of taste (dysgeusia)
• redness of the face and often other skin areas (flushing)
• runny nose (rhinorrhea)
• acid reflux (gastroesophageal reflux disease)
• skin cancer (keratoacanthoma/squamous cell skin cancer)
• 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)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder and/or bile ducts
• yellowing of the skin or eyes (jaundice) due to high levels of bile pigments (hyperbilirubinemia)
• allergic reactions (including skin reactions and hives)
• dehydration
• breast enlargement (gynecomastia)
• difficulty breathing (lung disease)
• eczema
• overactivity of the thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• abnormally high blood pressure
• holes in the abdominal wall (gastrointestinal perforation)
• reversible inflammation in the back of the brain that may be associated with headache, altered consciousness, seizures, and visual symptoms including vision loss (posterior reversible encephalopathy syndrome)
• sudden and severe allergic reactions (anaphylactic reaction)

Rare:

may affect up to 1 in 1,000 people

• allergic reaction with swelling of the skin (e.g., face, tongue) that may cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• liver inflammation, which may cause nausea, vomiting, abdominal pain, and yellowing of the skin (jaundice) (drug-induced hepatitis)
• a sunburn-like rash may appear on skin previously exposed to radiotherapy, and it may be severe (radiation recall dermatitis)
• severe skin and/or mucous membrane reactions, which may include painful blisters and fever, including extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis)
• kidney damage causing 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:

frequency cannot be estimated from the available data

• impaired brain function that may be associated with, for example, drowsiness, behavioral changes, or confusion (encephalopathy)
• enlargement and weakening of a blood vessel wall or tearing of a blood vessel wall (aneurysms and arterial dissections)
• nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue (tumour lysis syndrome [TLS] (see section 2).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sorafenib Teva

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

Nature and contents of the container

Sorafenib Teva 200 mg film-coated tablets are pink, round, biconvex tablets, engraved with "TV" on one side and "S3·" on the other. 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 blisters containing 112 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabael Segura, 11 Edificio Albatros B, 1ª planta
28108 Alcobendas (Madrid),
Spain

Manufacturer

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,
Kraków, 31-546,
Poland

or

Actavis Group PTC ehf.
Dalshraun 1,
220 Hafnarfjordur
Iceland

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Germany: Sorafenib-AbZ 200 mg Filmtabletten
Belgium: Sorafenib Teva 200 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Bulgaria: СораФЕНИБ ТЕВА 200 mg филм-покрити таблети 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 επικαλυμμένα με λεπτό υμένιο δισκία
Hungary: Sorafenib Teva 200 mg filmtabletta
Italy: Sorafenib Teva
Lithuania: Sorafenib Teva 200 mg plevele dengtos tabletės
Latvia: Sorafenib Teva 200 mg apvalkotas tabletes
Luxembourg: Sorafenib Teva 200 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

Date of the most recent review of this leaflet: July 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es