Sorafenib Stada 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sorafenib Stada 200 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 controlling the disease or is considered inappropriate.

Sorafenib is used in the treatment of thyroid cancer (differentiated thyroid carcinoma).

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 starting to take Sorafenib Stada

Do not take Sorafenib Stada

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take sorafenib.

Take special care with Sorafenib Stada

• If you experience 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 completely discontinue treatment.
• If you have hypertension. Sorafenib may increase blood pressure, and your doctor will usually monitor your blood pressure and may prescribe medication to treat your hypertension.
• If you have or have had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
• If you have diabetes. Blood sugar levels should be monitored regularly in diabetic patients to determine whether the dose of antidiabetic medication needs adjustment to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or fenprocoumon. Treatment with sorafenib may increase the risk of bleeding. If you are taking warfarin or fenprocoumon, which are blood-thinning medicines used to prevent blood clots, you may have an increased risk of bleeding.
• If you have chest pain or heart problems. Your doctor may decide to temporarily or completely 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 affect wound healing. If you are to undergo surgery, sorafenib treatment is usually stopped. Your doctor will decide when to restart sorafenib treatment.
• If you are taking irinotecan or docetaxel, which are also cancer medicines. Sorafenib may increase the effects, and in particular the adverse 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 adverse effects when taking this medicine.
• If you have renal 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, speak with your doctor.
• During treatment, holes in the intestinal wall (gastrointestinal perforation) may occur (see section 4: Possible side effects). In such a case, your doctor will discontinue treatment.
• If you have thyroid cancer. Your doctor will monitor blood levels of calcium and thyroid hormones.
• If you experience the following symptoms, contact your doctor immediately, as this may be 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]), and may lead to changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Inform your doctor if any of these conditions apply to you. You may require treatment for them, 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

Some medicines may affect sorafenib, or may be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine from this 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 epilepsy and other conditions
• Dexamethasone, a corticosteroid used for various conditions
• 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 being treated with sorafenib, inform your doctor immediately; your doctor will decide whether to continue treatment.

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

Driving and use of machines

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

Sorafenib Stada contains sodium

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

3. How to take Sorafenib Stada

The recommended dose of sorafenib in adults is 2 tablets of 200 mg, taken twice daily.

This is equivalent to a daily dose of 800 mg, or four tablets per day.

Swallow the sorafenib tablets with a glass of water, on an empty stomach 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.

Always follow exactly your doctor's instructions for taking this medicine. 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.

You will usually continue taking this medicine for as long as you are obtaining clinical benefit and do not experience unacceptable adverse 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 and severity of adverse effects, especially 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), contact your doctor or the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sorafenib Stada

If you forget 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 forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

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, painful 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)
• altered sensation in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• depression
• problems with erection (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin that peels (dermatitis, skin desquamation)
• heart failure
• heart attack (myocardial infarction) and chest pain
• tinnitus (ringing in the ears)
• 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 parts of the skin (flushing)
• runny nose (rhinorrhoea)
• acid reflux (gastroesophageal reflux disease)
• skin cancer (keratoacanthoma/squamous cell skin cancer)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contraction (muscle spasms)

Uncommon:

may affect up to 1 in 100 people

• inflammation of the stomach lining (gastritis)
• abdominal pain due to 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 (lung 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 swelling 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) that may cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• inflammation of the liver, 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 radiation therapy and may be severe (radiation recall dermatitis)
• severe skin and/or mucosal reactions that 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

• impaired brain function which may be associated with, for example, drowsiness, behavioural changes, or confusion (encephalopathy)
• swelling and weakening of a blood vessel wall or tearing of a blood vessel wall (aneurysms and arterial dissections)
• nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue (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 outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

For aluminum-OPA/Al/PVC blister packs:

This medicine does not require any special storage conditions.

For aluminum-PVC/PE/PVDC blister packs:

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of 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 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).

Appearance of the product and contents of the pack

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%.

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

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

Available in packs of 60 film-coated tablets in aluminum-OPA/Alu/PVC blisters.

Only certain 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

[email protected]

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 most recent revision of this leaflet: August 2024

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