SORAFENIB EUGIA 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Sorafenib is used to treat liver cancer (hepatocellular carcinoma).

Sorafenib is also used to treat advanced kidney cancer (advanced renal cell carcinoma) when standard treatment has not helped to control your disease or is considered inappropriate.

Sorafenib is used to treat thyroid cancer (differentiated thyroid carcinoma).

Sorafenib is a multi-kinase 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 Eugia

Do not takeSorafenib Eugia

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine.

Be particularly careful with Sorafenib Eugia

• If you have skin problems. Sorafenib may cause skin reactions and rashes, especially on the hands and feet. Your doctor can usually treat these conditions. If not, your doctor may interrupt or stop treatment.
• If you have high blood pressure. Sorafenib may increase blood pressure. Your doctor will check your blood pressure and may prescribe 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 medication is necessary to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or phenprocoumon. Treatment with sorafenib 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 may decide to interrupt or stop treatment.
• 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. Sorafenib may affect wound healing. You should usually interrupt your treatment with sorafenib if you are going to have surgery. Your doctor will decide when to restart treatment with sorafenib.
• If you are being treated with irinotecan or docetaxel, which are also cancer medicines. Sorafenib may increase the effects and, in particular, the side 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 side effects when taking this medicine.
• If you have kidney impairment. Your doctor will check your fluid and electrolyte balance.
• Fertility. Sorafenib may reduce male and female fertility. If you are concerned, consult 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 check 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, seizures, 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).

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

Children and adolescents

Sorafenib has not yet been tested in children and adolescents.

Other medicines and Sorafenib Eugia

Some medicines may affect sorafenib or be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed below 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 in various conditions.
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clots.
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which are cancer treatments.
• Digoxin, a treatment for mild or 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 sorafenib, inform your doctor immediately, who will decide whether you should continue treatment.

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

Driving and using machines

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

Sorafenib Eugia contains sodium

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

3. How to take Sorafenib Eugia

The recommended dose of sorafenib in adults is 2 tablets of 200 mg, twice a day.This is equivalent to a daily dose of 800 mg or 4 tablets per day.

Sorafenib 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 sorafenib. If you intend to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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

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

If you take more Sorafenib Eugia than you should

Consult your doctor immediatelyif you (or anyone else) have taken a dose higher than prescribed. Taking too much sorafenib increases the likelihood of side effects or their severity, especially diarrhea and skin reactions. Your doctor may advise you to stop taking this medicine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sorafenib Eugia

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular routine. 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.

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 and 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 sensitivity 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).
• reduced number of white blood cells (leucopenia and neutropenia).
• reduced number of red blood cells (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).
• distortion of the sense of taste (dysgeusia).
• redness of the face and often other areas of the skin (flushing).
• nasal discharge (rhinorrhea).
• heartburn (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 the 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).
• difficulty breathing (lung disease).
• eczema.
• overactive thyroid gland (hyperthyroidism).
• multiple skin eruptions (erythema multiforme).
• abnormally high blood pressure.
• holes in the wall 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 (prolonged QT interval).
• 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 previously exposed to radiation and can be severe (radiation recall 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: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, seizures, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sorafenib Eugia

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 is the last day of the month shown.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sorafenib Eugia

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

Tablet core:microcrystalline cellulose, crospovidone, colloidal silicon dioxide, hypromellose, sodium lauryl sulfate, and saccharose and stearic acid ester.

Tablet coating:HPMC 2910/hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172).

Appearance of the product and pack contents

Red, round, biconvex film-coated tablets with "SI" marked on one side and smooth on the other.

Sorafenib Eugia film-coated tablets are available in blister packs of 112 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Spain: Sorafenib Eugia 200 mg film-coated tablets EFG

France: SORAFENIB ARROW 200 mg, film-coated tablet

Portugal: Sorafenib Eugia

Date of last revision of this leaflet: December 2024

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