SORAFENIB STADA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sorafenib Stada 400 mg film-coated tablets

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 experience 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 Stada is and what it is 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 Sorafenib Stada 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 worked to slow down the disease or is considered inappropriate.

Sorafenib is a so-called 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 Stada

Do not takeSorafenib Stada

• 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 starting to take sorafenib.

Be careful with Sorafenib Stada

• 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 spasms, 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 can cause changes in kidney function and acute kidney failure (see also section 4: Possible side effects).
• If you experience skin problems. Sorafenib may cause rashes and skin reactions, 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. 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 blood clots, 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 problems. 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) may occur (see section 4: Possible side effects). In this case, your doctor will interrupt treatment.

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

Children and adolescents

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

Other medicines andSorafenib Stada

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 epilepsyand other diseases
• Dexamethasone, a corticosteroidused 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 breastfeeding

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 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 evidence that sorafenib can affect your ability to drive or use machines.

Sorafenib Stadacontains sodium

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

3. How to take Sorafenib Stada

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of sorafenib in adults is 400 mg, twice a day.

This is equivalent to a daily dose of 800 mg or two tablets per 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 for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

It is important to take this medicine at the same time each day, so that there is a constant amount in the bloodstream.

The score line is only to help you break the tablet if you have difficulty swallowing it whole.

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

If you take more Sorafenib Stada than you should

Tell your doctor immediatelyif you (or someone else) 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), talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Sorafenib Stada

If you miss a dose, take it as soon as you remember. If it is near the time of your next dose, do not take the missed dose. Do not take a double dose to make up for forgotten 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 affect more than 1 in 10 people

• diarrhea
• feeling of nausea
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss (alopecia)
• redness and 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, 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 levels (hypoglycemia)
• muscle pain (myalgia)
• nerve damage (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) and chest pain
• ringing in the ears (tinnitus)
• kidney failure
• high levels of protein in the urine (proteinuria)
• general weakness or loss of strength (asthenia)
• low white blood cell count (leukopenia and neutropenia)
• low red blood cell count (anemia)
• low platelet count (thrombocytopenia)
• inflammation of the hair follicles (folliculitis)
• underactive thyroid gland (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste changes (dysgeusia)
• redness of the face and often other parts of the skin (flushing)
• runny nose (rhinorrhea)
• acid reflux (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 bile ducts
• yellowing 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)
• breathing difficulties (pulmonary 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 (posterior reversible 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 yellowing of the skin (drug-induced hepatitis)
• a rash similar to sunburn may appear 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 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)
• difficulty breathing, irregular heartbeats, muscle spasms, 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 Monitoring System for Human Use: 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.

This medicine does not require any special storage conditions.

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

6. Packaging Content and Additional Information

Composition ofSorafenib Stada

• The active ingredient is sorafenib. Each film-coated tablet contains 400 mg of sorafenib (as tosylate).
• The other ingredients are:

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

Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521).

Appearance and Packaging of the Product

Sorafenib Stada 400 mg are film-coated tablets, white to off-white in color, oval in shape, with a score line on one side and smooth on the other, with dimensions of 20.1 mm x 10.1 mm ± 5%.

Sorafenib Stada 400 mg is available in:

Packaging with aluminum-OPA/Alu/PVC blisters containing 28, 30, 56, 60, multiple packaging of 84 (3 packages of 28), multiple packaging of 112 (4 packages of 28), multiple packaging of 120 (4 packages of 30) film-coated tablets.

Packaging with single-dose perforated aluminum-OPA/Alu/PVC blisters containing 28x1, 30x1, 56x1, 60x1, multiple packaging of 84x1 (3 packages of 28x1), multiple packaging of 112x1 (4 packages of 28x1), multiple packaging of 120x1 (4 packages of 30x1) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory 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

PharOS MT Ltd

HF62X, Hal Far Industrial Estate

Birzebbugia BBG3000

Malta

or

Stada Arzneimittel AG

Stadastrasse 2-18

Bad Vilbel 61118

Germany

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 Prospectus:July 2022

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