Sorafenib Stada 400 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sorafenib Stada 400 mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if the reaction is not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Sorafenib is used in the treatment of liver cancer (hepatocellular carcinoma).

Sorafenib is also used in the treatment of advanced kidney cancer (advanced renal cell carcinoma) when standard treatment has not been effective in stopping the progression of the disease or is considered inappropriate.

Sorafenib is a so-called multikinase inhibitor. It works by slowing down the growth rate of cancer cells and by interrupting the blood supply that supports the growth of cancer cells.

2. What you need to know before taking Sorafenib Stada

Do not take Sorafenib Stada

• If you are allergic to 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 treatment with sorafenib.

Take special care with Sorafenib Stada

• If you experience the following symptoms, contact your doctor immediately, as they may indicate a potentially life-threatening condition: nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These may be caused by a group of metabolic complications that can occur during cancer treatment, resulting from the breakdown products of dying cancer cells (tumor lysis syndrome [TLS]), which can lead to changes in kidney function and acute renal failure (see also section 4: Possible side effects).
• If you develop skin problems. Sorafenib may cause rashes and skin reactions, especially on the hands and feet. Your doctor can usually manage these conditions. If not, your doctor may temporarily or permanently discontinue treatment.
• If you have high blood pressure (hypertension). Sorafenib may increase blood pressure. Your doctor will usually monitor your blood pressure and may prescribe medication to treat hypertension.
• If you have or have had an aneurysm (a bulge and weakening in 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 monitored in diabetic patients to determine whether the dose of antidiabetic medication needs adjustment, in order to minimize the risk of low blood sugar levels.
• If you have bleeding disorders or are taking warfarin or fenprocoumon. Treatment with sorafenib may increase the risk of bleeding. If you are taking warfarin or fenprocoumon—medications that thin the blood to prevent clot formation—you may have an increased risk of bleeding.
• If you have chest pain or heart problems. Your doctor may decide to temporarily or permanently discontinue treatment.
• If you have a heart disorder, such as an abnormal electrical signal known as "QT interval prolongation."
• If you are scheduled for surgery or have recently undergone surgery. Sorafenib may impair wound healing. If you are due to have surgery, sorafenib treatment will usually be stopped. Your doctor will decide when it is safe to restart sorafenib treatment.
• If you are taking irinotecan or docetaxel, which are also cancer medications. Sorafenib may increase their effects, particularly their adverse effects.
• 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 adverse effects when taking this medicine.
• If you have kidney impairment. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. Sorafenib may reduce fertility in both men and women. If this applies to you, discuss it with your doctor.
• During treatment, gastrointestinal perforations (holes in the intestinal wall) may occur (see section 4: Possible side effects). In such cases, your doctor will discontinue treatment.

Tell your doctor if any of these apply to you. You may require treatment for these conditions, or your doctor may decide to adjust your dose of sorafenib or discontinue treatment completely (see also section 4: Possible side effects).

Children and adolescents

Sorafenib has not yet been studied in children and adolescents.

Other medicines and Sorafenib Stada

Some medicines may affect sorafenib or be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 for various diseases
• Warfarin or fenprocoumon, anticoagulants used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, used 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 are able to become pregnant, use an effective method of contraception during treatment. If you become pregnant while receiving sorafenib, inform your doctor immediately; your doctor will decide whether treatment should continue.

You must not breastfeed during treatment with sorafenib, as this medicine may interfere with your baby's growth and development.

Driving and using machines

There is no evidence that sorafenib affects the ability to drive or operate machinery.

Sorafenib Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially "sodium-free".

3. How to take Sorafenib Stada

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of sorafenib in adults is 400 mg twice daily.

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- to moderate-fat meal. Do not take this medicine with a high-fat meal, as this reduces the effectiveness of sorafenib. If you plan to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.

Follow exactly the instructions for taking this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The tablet score is intended only for splitting the tablet if you have difficulty swallowing it whole.

You will usually continue taking this medicine for as long as you are obtaining clinical benefit and do not experience unacceptable side effects.

If you take more Sorafenib Stada than you should

Inform your doctor immediately if you (or someone else) have taken more than the prescribed dose. Taking too much sorafenib increases the likelihood of side effects occurring or of them being more severe, particularly diarrhea and skin reactions. Your doctor may instruct 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 at telephone number 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 close to the time for your next dose, do not take the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. This medicine may also affect the results of certain blood tests.

Very common:

may affect more than 1 in 10 people

• diarrhoea
• feeling sick (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain)
• hair loss (alopecia)
• red, sore palms and soles (hand-foot skin reaction)
• itching or rash
• vomiting
• bleeding (including bleeding in the brain, intestinal wall, and respiratory tract, haemorrhage)
• high blood pressure, or increase in 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, tongue pain (stomatitis and mucosal inflammation)
• low levels of calcium in the blood (hypocalcaemia)
• low levels of potassium in the blood (hypokalaemia)
• low levels of blood sugar (hypoglycaemia)
• muscle pain (myalgia)
• changes in sensation in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• depression
• erection problems (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin peeling)
• heart failure
• heart attack (myocardial infarction) and chest pain
• tinnitus (ringing in the ear)
• 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 (leucopenia and neutropenia)
• decrease in the number of red blood cells (anaemia)
• low number of platelets in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• reduced activity of the thyroid gland (hypothyroidism)
• low levels of sodium in the blood (hyponatraemia)
• altered sense of taste (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinorrhoea)
• 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 or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia)
• allergic reactions (including skin reactions and hives)
• dehydration
• breast enlargement (gynaecomastia)
• difficulty breathing (pulmonary disease)
• eczema
• overactivity of the thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• abnormally high blood pressure
• holes in the abdominal wall (gastrointestinal perforation)
• reversible inflammation in the back part of the brain that may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (reversible posterior leucoencephalopathy)
• sudden and 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) which may cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• liver inflammation, which may cause nausea, vomiting, abdominal pain, and yellowing of the skin (jaundice) (drug-induced hepatitis)
• a sunburn-like rash may appear on skin previously exposed to radiotherapy and may be severe (radiation recall dermatitis)
• severe skin and/or mucous membrane reactions which may include painful blisters and fever, including extensive peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown which may lead to kidney problems (rhabdomyolysis)
• kidney damage causing loss of large amounts of protein (nephrotic syndrome)
• inflammation of blood vessels in the skin which may cause a rash (leucocytoclastic vasculitis)

Frequency not known

frequency cannot be estimated from the available data

• brain dysfunction which may be associated with, for example, drowsiness, behavioural changes, or confusion (encephalopathy)
• bulging and weakening of a blood vessel wall or tearing of a blood vessel wall (aneurysms and arterial dissections)
• difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and tiredness (tumour lysis syndrome [TLS]) (see section 2)

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sorafenib Stada

• The active substance 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 of the product and contents of the pack

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

Sorafenib Stada 400 mg is available in:

Aluminum-OPA/Alu/PVC blister packs containing 28, 30, 56, 60 tablets; multiple packs of 84 (3 packs of 28), 112 (4 packs of 28), and 120 (4 packs of 30) film-coated tablets.

Unit dose perforated aluminum-OPA/Alu/PVC blister packs containing 28x1, 30x1, 56x1, 60x1 tablets; multiple packs of 84x1 (3 packs of 28x1), 112x1 (4 packs of 28x1), and 120x1 (4 packs of 30x1) film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

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 most recent revision of this leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es