Sorafenib Teva

Package Leaflet: Information for the User

Sorafenib Teva, 200 mg, Film-Coated Tablets

Sorafenib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Sorafenib Teva and what is it used for
• 2. Important information 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 is Sorafenib Teva and what is it used for

Sorafenib Teva is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Teva is also used to treat kidney cancer in advanced stages (advanced renal cell carcinoma) in patients who have not responded to standard therapy or for whom it is not indicated.
Sorafenib Teva is a so-called multi-kinase inhibitor. It works by reducing the growth rate of cancer cells and cutting off the blood supply that supports the growth of cancer cells.

2. Important information before taking Sorafenib Teva

When not to take Sorafenib Teva

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

Warnings and precautions

Before starting treatment with Sorafenib Teva, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Sorafenib Teva

• If skin changes occur. Sorafenib Teva may cause rash and skin reactions, especially on the hands and feet. These changes can usually be treated by your doctor. If they do not improve, your doctor may temporarily stop treatment or discontinue it altogether.
• If you have high blood pressure. Sorafenib Teva may increase blood pressure. Your doctor will check your blood pressure and may prescribe medication to lower it if necessary.
• If you have or have had an aneurysm(enlargement and weakening of the blood vessel wall) or a rupture of the blood vessel wall.
• If you have diabetes.In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of anti-diabetic medication needs to be adjusted to minimize the risk of lowering blood sugar levels.
• If you experience any bleeding or if you are taking warfarin or phenprocoumon.Treatment with Sorafenib Teva may increase the risk of bleeding. A person 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 stop treatment with Sorafenib Teva or discontinue it altogether.
• If you experience heart rhythm disorders, such as abnormal electrical activity, called "QT interval prolongation".
• If you are planning to have surgery or have recently had an operation. Sorafenib Teva may affect wound healing. Usually, Sorafenib Teva is stopped in case of surgery. Your doctor will decide when to resume treatment with Sorafenib Teva.
• If you are also taking irinotecan or receiving docetaxel,which are also medicines used to treat cancer. Sorafenib Teva may enhance their effect, especially adverse reactions.
• If you are taking neomycin or other antibiotics, the effectiveness of Sorafenib Teva may be reduced.
• If you have severe liver dysfunction, more serious adverse reactions may occur during treatment.
• In case of impaired kidney function, your doctor will monitor fluid and electrolyte balance.
• If you experience any of the following symptoms, you should contact your doctor immediately, as it may be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. Such symptoms may be caused by a group of metabolic complications that may occur during cancer treatment, caused by the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).
• Fertility.Sorafenib Teva may reduce fertility in both men and women. Any fertility issues should be discussed with your doctor.
• Gastrointestinal perforation.During treatment, a rupture of the gastrointestinal wall may occur (see also section 4: Possible side effects). In this case, your doctor will recommend stopping treatment.

You should inform your doctor if any of the above circumstances apply to you

who has been prescribed Sorafenib Teva.In these cases, appropriate treatment may be necessary, and your doctor may decide to change the dosage of Sorafenib Teva or discontinue it altogether (see also section 4: Possible side effects).

Children and adolescents

So far, no studies have been conducted on the use of Sorafenib Teva in children and adolescents.

Sorafenib Teva and other medicines

Some medicines may affect the action of Sorafenib Teva, or their action may be changed by Sorafenib Teva. You should tell your doctor or pharmacist about any of the following medicines and any other medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription:

• Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
• St. John's Wort, used to treat depression
• Phenytoin, carbamazepine, or phenobarbital, medicines used in epilepsy and other conditions
• Dexamethasone, a corticosteroid given in various conditions
• Warfarin or phenprocoumon, anticoagulant medicines given to prevent thrombosis
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - anticancer medicines
• Digoxin, used to treat mild and moderate heart failure

Pregnancy and breastfeeding

You should avoid becoming pregnant while taking Sorafenib Teva. If there is a possibility that you may become pregnant, you should use effective contraception during treatment.
If you become pregnant during treatment with Sorafenib Teva, you should contact your doctor immediately, who will decide whether to continue treatment.
You should not breastfeed while taking Sorafenib Teva, as sorafenib may affect the growth and development of the child.

Driving and using machines

There is no data indicating that sorafenib may impair the ability to drive and use machines.

Sorafenib Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means that the medicine is considered "sodium-free".

3. How to take Sorafenib Teva

The recommended dose of Sorafenib Teva for adults is two 200 mg tablets, twice a day

This corresponds to a daily dose of 800 mg or four tablets per day.
Sorafenib Teva should be swallowed with a glass of water, on an empty stomach or with meals with low or moderate fat content. Do not take the medicine with high-fat meals, as this may reduce the effectiveness of Sorafenib Teva. If you plan to have a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
This medicine should always be taken according to your doctor's instructions. If you have any doubts, ask your doctor or pharmacist.
It is important to take this medicine at the same time every day to ensure a constant amount of the medicine in the bloodstream.
This medicine is usually taken for as long as it provides clinical benefits and as long as the person taking it does not experience unacceptable side effects.

Taking a higher dose of Sorafenib Teva than recommended

You should immediately inform your doctorif you (or anyone else) have taken a dose of Sorafenib Teva higher than recommended. Taking too much Sorafenib Teva may increase the risk of side effects or worsen them, especially diarrhea and skin reactions. Your doctor may recommend stopping treatment with this medicine.

Missing a dose of Sorafenib Teva

If you miss a dose, you should take it as soon as you remember.
If the time for the next dose is near, skip the missed dose and continue treatment as before. Do not take a double dose to make up for missed single doses.

4. Possible side effects

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

Very common:

may occur in more than 1 in 10 people

• diarrhea
• nausea (vomiting)
• feeling weak or tired
• pain (including pain in the mouth, abdominal pain, bone pain, headache, tumor pain)
• hair loss (alopecia)
• redness or pain in the hands or feet (hand-foot syndrome)
• itching or rash
• vomiting
• bleeding (including cerebral, gastrointestinal, respiratory, or hemorrhage)
• 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 occur in less than 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness of the mouth, tongue pain (stomatitis and mucositis)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar levels (hypoglycemia)
• muscle pain (myalgia)
• disorders of sensation in the fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• depression
• erectile dysfunction (impotence)
• voice changes (dysphonia)
• acne
• skin inflammation, dry and flaky skin (dermatitis and desquamation)
• heart failure
• heart attack (myocardial infarction) or chest pain
• tinnitus (ringing in the ears)
• kidney failure
• exceptionally high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• reduced white blood cell count (leukopenia and neutropenia)
• reduced red blood cell count (anemia)
• reduced platelet count (thrombocytopenia)
• inflammation of the hair follicles (folliculitis)
• reduced thyroid function (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste disorders (dysgeusia)
• redness of the face and often other skin areas (flushing)
• runny nose (rhinitis)
• heartburn (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma/skin carcinoma)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contractions (muscle spasms)

Uncommon:

may occur in less than 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) caused by high levels of bile pigments (hyperbilirubinemia)
• allergic reactions (including skin reactions and hay fever)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (lung disease)
• eczema
• increased thyroid function (hyperthyroidism)
• multiple, diverse skin rashes (erythema multiforme)
• exceptionally high blood pressure
• perforation of the gastrointestinal tract
• reversible posterior leukoencephalopathy, which may be associated with headache, altered consciousness, seizures, and vision disturbances, including loss of vision (reversible posterior leukoencephalopathy)
• sudden, severe allergic reaction (anaphylactic reaction)

Rare:

may occur in less than 1 in 1000 people

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

Unknown:
frequency cannot be estimated from the available data

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sorafenib Teva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry datestated on the carton and each blister after: EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sorafenib Teva contains

• The active substanceis sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as sorafenib tosylate).
• Otheringredients are: Core:microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hypromellose, magnesium stearate. Coating:hypromellose, macrogol, 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 with the inscription "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, as well as perforated single-dose blister packs containing 112 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. 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.
ul. Mogilska 80, 31-546 Kraków
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipoviča 25, 10000 Zagreb, Croatia
Teva Pharma B.V.,
Swensweg 5, 2031 GA Haarlem, Netherlands
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjordur
Iceland

Date of last revision of the package leaflet: November 2023