Sorafenib Zentiva

Package Leaflet: Information for the Patient

Sorafenib Zentiva, 200 mg, Film-Coated Tablets

Sorafenib

Read the package leaflet carefully before taking the medicine, as 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. 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Sorafenib Zentiva is used to treat:

• –liver cancer (hepatocellular carcinoma).
• –advanced kidney cancer (advanced renal cell carcinoma) in patients who have not responded to standard therapy or for whom it is not indicated.
• –thyroid cancer (differentiated thyroid carcinoma).

Sorafenib Zentiva 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 tumor growth.

2. Important information before taking Sorafenib Zentiva

When not to take Sorafenib Zentiva:

• 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 Zentiva, discuss it with your doctor or pharmacist.

When to be particularly cautious when taking Sorafenib Zentiva

• If skin changes occur.Sorafenib Zentiva may cause skin rash and skin reactions, especially on the palms of the hands and soles of the 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 Zentiva 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 wall of a blood vessel) or a rupture of a blood vessel.
• If you have diabetes. In diabetic patients, 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 low blood sugar.
• If bleeding occurs or if you are taking warfarin or fenprocoumon.Treatment with Sorafenib Zentiva may increase the risk of bleeding. A person taking warfarin or fenprocoumon, which reduce blood clotting to prevent clots, may have an increased risk of bleeding.
• If you experience chest pain or heart problems. Your doctor may decide to stop treatment or discontinue it altogether.
• If you experience heart rhythm disorders, such as abnormal electrical activity, known as "prolonged QT interval".
• If you are scheduled for surgery or have recently undergone surgery.Sorafenib Zentiva may affect wound healing. Treatment with Sorafenib Zentiva is usually stopped in case of surgery. Your doctor will decide when to resume treatment with Sorafenib Zentiva.
• If you are also taking irinotecan or receiving docetaxel, which are also cancer medicines. Sorafenib Zentiva may enhance their effects, especially side effects.
• If you are taking neomycin or other antibiotics.The effectiveness of Sorafenib Zentiva 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 fluid and electrolyte balance.
• Fertility. Sorafenib Zentiva 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 advise stopping treatment.
• If you have thyroid cancer. Your doctor will monitor calcium and thyroid hormone levels in your blood.
• If you experience any of the following symptoms, 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.These symptoms may be caused by a group of metabolic complications that can occur during cancer treatment, caused by the breakdown products of dying cancer cells (tumor lysis syndrome) and can lead to kidney dysfunction and acute kidney failure (see also section 4: Possible side effects).

Tell your doctor if any of the above situations apply to you.

In these cases, appropriate treatment may be necessary, and your doctor may decide to change the dose of Sorafenib Zentiva or stop treatment altogether (see also section 4: Possible side effects).

Children and adolescents

No studies have been conducted on the use of Sorafenib Zentiva in children and adolescents.

Sorafenib Zentiva and other medicines

Some medicines may affect the action of Sorafenib Zentiva, or their action may be altered by Sorafenib Zentiva. 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 antibiotics.
• St. John's Wort, used to treat depression.
• Phenytoin, carbamazepine, or phenobarbital, used to treat epilepsy and other conditions.
• Dexamethasone, a corticosteroid used in various diseases.
• Warfarin or fenprocoumon, anticoagulant medications used to prevent clots.
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - anticancer medicines.
• Digoxin, used to treat mild to moderate heart failure.

Pregnancy and breastfeeding

Avoid becoming pregnant while taking Sorafenib Zentiva.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 Zentiva, contact your doctor immediately, who will decide whether to continue treatment.
Do not breastfeed while taking Sorafenib Zentiva, as sorafenib may affect the growth and development of the child.

Driving and using machines

There is no data to suggest that Sorafenib Zentiva may impair the ability to drive or operate machines.

Sorafenib Zentiva contains sodium

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

3. How to take Sorafenib Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose of Sorafenib Zentiva for adults is 2 tablets of 200 mg, twice a day.

This corresponds to a daily dose of 800 mg or 4 tablets per day.
Sorafenib Zentiva tablets should be swallowed with a glass of water, on an empty stomach or with meals low to moderate in fat. Do not take the medicine with high-fat meals, as this may reduce the effectiveness of Sorafenib Zentiva. 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 as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
It is important to take this medicine at the same time every day to ensure a constant amount of medicine in the blood.
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 Zentiva than recommended

Inform your doctor immediatelyif you (or someone else) have taken a dose higher than recommended. Taking too much Sorafenib Zentiva may increase the risk of side effects or make them worse, especially diarrhea and skin reactions. Your doctor may advise stopping treatment.

Missing a dose of Sorafenib Zentiva

If you miss a dose, 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 doses.

4. Possible side effects

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

Very common:

may affect more than 1 in 10 people

• Diarrhea;
• Nausea (vomiting);
• Feeling weak or tired;
• Pain (including pain in the mouth, abdominal pain, headache, bone pain, tumor pain);
• Hair loss (alopecia);
• Redness or pain on the palms of the hands or soles of the 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;
• Lack of appetite (anorexia);
• Constipation;
• Joint pain (arthralgia);
• Fever;
• Weight loss;
• Dry skin.

Common:

may affect up to 1 in 10 people

• Flu-like symptoms;
• Indigestion (dyspepsia);
• Difficulty swallowing (dysphagia);
• Inflammation or dryness of the mouth, pain in the tongue (stomatitis and mucositis);
• Low calcium levels in the blood (hypocalcemia);
• Low potassium levels in the blood (hypokalemia);
• Low blood sugar (hypoglycemia);
• Muscle pain (myalgia);
• Disorders of sensation in the fingers of the hands and feet, including tingling or numbness (peripheral sensory neuropathy);
• Depression;
• Erectile dysfunction (impotence);
• Change in voice (dysphonia);
• Acne;
• Characteristics of skin inflammation, dry and flaky skin (dermatitis and desquamation);
• Heart failure;
• Heart attack (myocardial infarction) or chest pain;
• Ringing in the ears (tinnitus);
• Kidney failure;
• Very high levels of protein in the urine (proteinuria);
• General weakness or loss of strength (asthenia);
• Decreased number of white blood cells (leukopenia and neutropenia);
• Decreased number of red blood cells (anemia);
• Low platelet count (thrombocytopenia);
• Inflammation of the hair follicles (folliculitis);
• Decreased thyroid function (hypothyroidism);
• Low sodium levels in the blood (hyponatremia);
• Taste disorders (dysgeusia);
• Redness of the face and often other areas of the skin (flushing);
• Runny nose (rhinitis);
• Heartburn (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 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 bilirubin (hyperbilirubinemia);
• Allergic reactions (including skin reactions and hives);
• Dehydration;
• Breast enlargement (gynecomastia);
• Difficulty breathing (lung disease);
• Eczema;
• Increased thyroid function (hyperthyroidism);
• Multiple skin rashes (erythema multiforme);
• Very high blood pressure;
• Perforation of the gastrointestinal tract (gastrointestinal perforation);
• Reversible posterior leukoencephalopathy, which may be associated with headache, altered mental status, seizures, and visual disturbances, including blindness (reversible posterior leukoencephalopathy syndrome);
• Sudden, severe allergic reaction (anaphylactic reaction).

Rare:

may affect up to 1 in 1000 people

• Allergic reaction with skin swelling (e.g., face, tongue), which can cause difficulty breathing or swallowing (angioedema);
• Abnormal heart rhythm (prolonged QT interval);
• Liver inflammation, which can cause nausea, vomiting, abdominal pain, and jaundice (drug-induced liver injury);
• Rash similar to sunburn, which can occur on skin previously exposed to radiation, and its severity can 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 can lead to kidney dysfunction (rhabdomyolysis);
• Kidney damage causing loss of large amounts of protein (nephrotic syndrome);
• Inflammation of the blood vessels in the skin, which can cause a rash (leukocytoclastic vasculitis).

Not known:

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 wall of a blood vessel or rupture of a blood vessel (aneurysm and arterial dissection).
• Nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue [tumor lysis syndrome (TLS)] (see also section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sorafenib Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry datestated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sorafenib Zentiva contains

• The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The other ingredients are: Tablet core: hypromellose 2910, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. Tablet coating: hypromellose 2910, titanium dioxide, macrogol, iron oxide red (E 172).

What Sorafenib Zentiva looks like and contents of the pack

Sorafenib Zentiva, 200 mg, film-coated tablets are red-brown, round, biconvex film-coated tablets with "200" engraved on one side, smooth on the other, with a diameter of 12.0 mm ± 5%.
The tablets are packaged in aluminum/PVC/PE/PVDC blisters containing 112 film-coated tablets, in a cardboard box.
The tablets are packaged in single-dose perforated aluminum-PVC/PE/PVDC blisters containing 112 x 1 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate, Birzebbugia BBG3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia, Italy, Poland, Slovakia, Czech Republic:
Sorafenib Zentiva
Netherlands:
Sorafenib Zentiva 200 mg, filmomhulde tabletten
France:
SORAFENIB ZENTIVA 200 mg, comprimé pelliculé
Latvia:
Sorafenib Zentiva 200 mg apvalkotās tablets
Lithuania:
Sorafenib Zentiva 200 mg plėvele dengtos tabletės
Bulgaria:
Сорафениб Зентива 200 mg филмирани таблетки
Romania:
Sorafenib Zentiva 200 mg comprimate filmate
United Kingdom (Northern Ireland)
Sorafenib Zentiva 200 mg film-coated tablets
Date of last revision of the leaflet:January 2025