SORAFENIB STADA 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

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

Sorafenib is also used to treat kidney cancer in advanced stages (advanced renal cell carcinoma) when standard treatment has not helped to slow down the disease or is considered inappropriate.

Sorafenib is used to treat 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 allows cancer cells to grow.

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

Do not take Sorafenib Stada

• If you are allergicto sorafenib or 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.

Be especially careful with Sorafenib Stada

• If you have skin problems. Sorafenib may cause skin rash and reactions, especially on 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. Sorafenib may increase blood pressure, and your doctor will usually check your blood pressure and may give you a medicine to treat your 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 should be regularly checked in diabetic patients in order to assess whether the dose of the anti-diabetic medication needs to be adjusted to minimize the risk of low blood sugar.
• If you have bleeding problems or are taking warfarin or phenprocoumon. Treatment with sorafenib may lead to an increased risk of bleeding. If you are taking warfarin or phenprocoumon, medicines that thin the blood to prevent clot formation, you may have a higher risk of bleeding.
• If you have chest pain or heart problems. Your doctor may decide 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 an operation. Sorafenib could affect wound healing. If you are going to have an operation, treatment with sorafenib will usually be stopped. Your doctor will decide when to restart treatment with sorafenib.
• If you are taking 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 failure. You may experience more severe side effects when taking this medicine.
• If you have kidney failure. Your doctor will check your fluid and electrolyte balance.
• Fertility. Sorafenib may reduce fertility in both men and women. If this is the case, talk to your doctor.
• During treatment, holes in the intestinal wall(gastrointestinal perforation) (see section 4: Possible side effects) may occur. 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 potentially life-threatening condition: nausea, difficulty breathing, irregular heartbeats, muscle cramps, seizures, cloudy urine, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment, which are caused by 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 aspects affect you. You may need treatment for them, or your doctor may decide to change your dose of sorafenib, or interrupt treatment completely (see also section 4: Possible side effects).

Children and adolescents

Tests with sorafenib in children and adolescents have not yet been performed.

Other medicines and Sorafenib

Some medicines may affect sorafenib, or may be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
• St. John's Wort, a herbal treatment for depression
• Phenytoin, carbamazepine, or phenobarbital, treatments for epilepsy and other diseases
• Dexamethasone, a corticosteroid used for various diseases
• Warfarin or phenprocoumon, anticoagulants used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, for cancer treatment
• Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breast-feeding

Avoid becoming pregnant while being treated with sorafenib. If you can become pregnant, use an adequate contraceptive method during treatment. If you become pregnant while being treated with sorafenib, inform your doctor immediately, who will decide whether you should continue treatment.

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

Driving and using machines

There is no evidence that sorafenib can affect your ability to drive or use machines.

Sorafenib Stada contains sodium

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

3. How to take Sorafenib Stada

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 four tablets a day.

Swallow the sorafenib tablets with a glass of water, without food 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 take a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is important to take this medicine at the same time every day, so that there is a constant 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 Stada than you should

Tell your doctor immediatelyif you (or someone) have taken more than the prescribed dose. Taking too much sorafenib increases the likelihood of side effects or makes them more severe, especially diarrhea and skin reactions. Your doctor may tell 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sorafenib Stada

If you have forgotten a dose, take it as soon as you remember. If it is near the time of the next dose, do not take the missed dose and continue as normal. Do not take a double dose to make up for missed doses.

In case of doubt about the use of this medicine, consult your doctor or pharmacist.

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 affect more than 1 in 10 people

• diarrhea
• feeling of dizziness (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss (alopecia)
• redness and pain of 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, hemorrhage)
• 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)
• dry or inflamed 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 (hypoglycemia)
• muscle pain (myalgia)
• alterations in sensitivity in the fingers of the hands and feet, including tingling or numbness (peripheral sensory neuropathy)
• depression
• erectile dysfunction (impotence)
• voice alteration (dysphonia)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin peeling)
• heart failure
• heart attack (myocardial infarction) and 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)
• decrease in the number of white blood cells (leukopenia and neutropenia)
• decrease in the 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)
• alteration of the sense of taste (dysgeusia)
• redness of the face and often other parts of the skin (flushing)
• nasal discharge (rhinorrhea)
• acidity (gastroesophageal reflux disease)
• skin cancer (keratoacanthoma/squamous cell skin cancer)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary contraction of a muscle (muscle spasms)

Uncommon:

may affect up to 1 in 100 people

• inflammation of the stomach wall (gastritis)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder, and/or bile ducts
• yellowish color of the skin or 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 rashes (erythema multiforme)
• abnormally high blood pressure
• holes in the intestinal wall (gastrointestinal perforation)
• reversible inflammation in the back of the brain that may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (reversible posterior leukoencephalopathy syndrome)
• sudden, 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 can cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (prolonged QT interval)
• inflammation of the liver, which can cause nausea, vomiting, abdominal pain, and yellowish color of the skin (drug-induced hepatitis)
• a rash similar to sunburn on the 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 and 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 loss of large amounts of protein (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, 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, 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 Stada

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 stated.

For the aluminum-OPA/Al/PVC blister:

This medicine does not require any special storage conditions.

For the aluminum-PVC/PE/PVDC blister:

Do not store above 30°C.

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

6. Package Contents and Additional Information

Composition ofSorafenib Stada

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

Core of the tablet: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).

Appearance of the Product and Package Contents

Sorafenib Stada 200 mg film-coated tablets are red-brown, round, biconvex tablets, engraved with "200" on one side and smooth on the other. The tablets have a diameter of 12.0 mm ± 5%.

They are available in packs of 56, 112 film-coated tablets in aluminum-PVC/PE/PVDC blisters.

They are available in packs of 56 x 1, 112 x 1 film-coated tablets in single-dose perforated aluminum-PVC/PE/PVDC blisters.

They are available in packs of 60 film-coated tablets in aluminum-OPA/Alu/PVC blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

or

Stada Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

or

Stada Arzneimittel GmbH

Muthgasse 36/2

Doebling, Vienna 1190

Austria

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbugia

Malta

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14,

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

Date of the Last Revision of this Leaflet:August 2024

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