SORAFENIB VIATRIS 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sorafenib Viatris 200mg film-coated tablets EFG

sorafenib

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sorafenib Viatris is and what it is used for
2. What you need to know before you take Sorafenib Viatris
3. How to take Sorafenib Viatris
4. Possible side effects
5. Storage of Sorafenib Viatris
6. Contents of the pack and other information

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

This medicine is used to treat liver cancer (hepatocellular carcinoma).

This medicine is also used to treat advanced kidney cancer (advanced renal cell carcinoma)when standard treatment has not worked to slow down your disease or is considered inappropriate.

This medicine is used to treat thyroid cancer (differentiated thyroid carcinoma).

This medicine is a multikinase inhibitor. It works by slowing down the rate of growth of cancer cells and interrupting the blood supply that allows cancer cells to grow.

2. What you need to know before you take Sorafenib Viatris

Do not take Sorafenib Viatris

• If you are allergicto 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 you start taking this medicine.

Be careful with Sorafenib Viatris

• If you have skin problems.This medicine can cause skin reactions and rashes, especially on the hands and feet. Your doctor can usually treat these conditions. If not, your doctor may interrupt treatment temporarily or completely.
• If you have high blood pressure.This medicine can increase blood pressure. Your doctor will check your blood pressure and may give you a medicine to treat high blood pressure.
• If you have or have had an aneurysm(enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have diabetes.Blood sugar levels in diabetic patients should be regularly checked to assess whether a dose adjustment of the anti-diabetic medicine is necessary to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or phenprocoumon.Treatment with this medicine may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, medicines that thin the blood to prevent blood clots, you may have a higher risk of bleeding.
• If you have chest pain or heart problems.Your doctor will decide whether to interrupt treatment temporarily or completely.
• If you have a heart disorder,such as an abnormal electrical signal called “prolonged QT interval”.
• If you are going to have surgery or have recently had surgery.This medicine may affect wound healing. You should usually stop taking this medicine if you are going to have surgery.

Your doctor will decide when to restart treatment with this medicine.

• If you are taking irinotecan or docetaxel,which are also anti-cancer medicines.

This medicine may increase the effects and, in particular, the side effects of these medicines.

• If you are taking neomycin or other antibiotics.The effect of this medicine may decrease.
• If you have severe liver impairment.You may experience more severe side effects when taking this medicine.
• If you have kidney impairment.Your doctor will monitor your fluid and electrolyte balance.
• Fertility.This medicine may reduce male and female fertility. If this applies to you, talk to your doctor.
• During treatment, holes in the walls of the intestine(gastrointestinal perforation)may occur (see section 4: Possible side effects). In this case, your doctor will interrupt treatment.
• If you have thyroid cancer.Your doctor will monitor your blood calcium and thyroid hormone levels.
• If you experience the following symptoms, contact your doctor immediately, as it may be a life-threatening situation:nausea, difficulty breathing, irregular heartbeats, muscle cramps, convulsions, cloudy urine, and fatigue. The cause may be a set of metabolic complications that can 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).

Talk to your doctor if any of these apply to you.It may be necessary to treat them or your doctor may decide to change your dose of this medicine or interrupt treatment completely (see also section 4: Possible side effects).

Children and adolescents

This medicine has not been tested in children and adolescents.

Other medicines and Sorafenib Viatris

Some medicines affect this medicine or may be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed in the following 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 epilepsyand other conditions
• Dexamethasone, a corticosteroidused in various conditions
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clot formation
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which are anti-cancer treatments
• Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant during treatment with sorafenib.If you can become pregnant, use adequate contraceptive methods during treatment. If you become pregnant during treatment with this medicine, tell your doctor immediately, who will decide whether you should continue treatment.

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

Driving and using machines

There is no indication that this medicine affects the ability to drive or use machines.

Sorafenib Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Sorafenib Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

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

This is equivalent to a daily dose of 800 mg or 4 tablets a day.

Sorafenib Viatris tablets should be taken with a glass of wateroutside of meals or with a low- or moderate-fat meal. Do not take this medicine with a high-fat meal, as this reduces the effectiveness of this medicine. If you plan to have a high-fat meal, take the sorafenib tablets at least 1 hour before or 2 hours after the meal.

It is important to take this medicine at the same time every day to keep a steady amount in the bloodstream.

Normally, you will continue to take this medicine while it provides clinical benefits and does not cause unacceptable side effects.

If you take more Sorafenib Viatris than you should

Talk to your doctor immediatelyif you (or someone else) have taken a dose higher than prescribed. Taking too much of this medicine increases the likelihood of side effects or makes them more severe, especially diarrhea or skin problems. Your doctor may tell you to stop taking this medicine.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sorafenib Viatris

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine may also affect some laboratory test results.

Very common:

may affect more than 1 in 10 people

• diarrhea
• nausea
• feeling weak or tired (fatigue)
• pain (including mouth pain, 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 skin reaction)
• itching or rash
• vomiting
• bleeding (including bleeding in the brain, intestinal wall, and respiratory tract)
• high blood pressure or increased 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)
• inflamed mouth or dry mouth, pain in the tongue (stomatitis and mucosal inflammation)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar levels (hypoglycemia)
• muscle pain (myalgia)
• altered sensation in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• depression
• erectile dysfunction (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin peeling)
• heart failure
• heart attack (myocardial infarction)or chest pain
• ringing in the ears (tinnitus)
• kidney failure
• abnormally high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• low white blood cell count (leucopenia and neutropenia)
• low red blood cell count (anemia)
• low platelet count in the blood (thrombocytopenia)
• inflammation of the hair follicles (folliculitis)
• underactive thyroid gland (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• distorted sense of taste (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinorrhea)
• heartburn (gastroesophageal reflux disease)
• skin cancer (keratoacanthoma/squamous cell carcinoma of the skin)
• 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 and eyes (jaundice)caused by high levels of bile pigments (hyperbilirubinemia)
• allergic reactions (including skin reactions and hives)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (lung disease)
• eczema
• overactive thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• abnormally high blood pressure
• holes in the walls of the intestine (gastrointestinal perforation)
• reversible inflammation of the back of the brain, which may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (reversible posterior leukoencephalopathy syndrome)
• severe allergic reaction (anaphylactic reaction)

Rare:

may affect up to 1 in 1,000 people

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

Frequency not known:

frequency cannot be estimated from the available data

• brain damage that can be associated with, for example, drowsiness, changes in behavior, or confusion (encephalopathy)
• enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)
• nausea, difficulty breathing, irregular heartbeats, muscle cramps, convulsions, cloudy urine, and fatigue (tumor lysis syndrome [TLS])(see section 2)

Reporting of side effects

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

5. Storage of Sorafenib Viatris

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

Do not use this medicine after the expiry datethat appears on the carton and on the blister after CAD or EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Sorafenib Viatris

• The active ingredient is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The other ingredients are:

Tablet core: hypromellose 2910 (E464), sodium croscarmellose (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514).

Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172). See Section 2 "Sorafenib Viatris contains sodium".

Appearance of Sorafenib Viatris and Container Content

Sorafenib Viatris are film-coated tablets of red-brown color, round, biconvex, film-coated, and marked with "200" on one side and smooth on the other, with a diameter of 12 mm.

Available in a container of 112 film-coated tablets in aluminum-PVC/PE/PVDC blisters.

Available in a container of 112 x 1 film-coated tablets in aluminum-PVC/PE/PVDC blisters of single-dose perforated doses.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

Or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbugia

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Germany Sorafenib Mylan 200 mg film-coated tablets

Bulgaria Sorafenib Mylan

Croatia Sorafenib Viatris 200 mg film-coated tablets

Denmark Sorafenib Viatris

Spain Sorafenib Viatris 200 mg film-coated tablets EFG

Finland Sorafenib Viatris

France Sorafénib Viatris 200 mg, film-coated tablet

Iceland Sorafenib Viatris

Italy Sorafenib Mylan 200 mg film-coated tablets

Norway Sorafenib Viatris

Poland Sorafenib Mylan

Portugal Sorafenib Mylan

United Kingdom Sorafenib 200 mg film-coated tablets

Czech Republic Sorafenib Viatris

Romania Sorafenib Viatris 200 mg film-coated tablets

Sweden Sorafenib Mylan

Date of the last revision of this prospectus: July 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)