Sorafenib Stada

Leaflet attached to the packaging: Patient information

Sorafenib Stada, 200 mg, coated tablets

Sorafenib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Sorafenib Stada is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Stada is also used to treat kidney cancer in advanced stages
(advanced renal cell carcinoma)in patients who have not responded to standard therapy or for whom it is not indicated. Sorafenib Stada is used to treat thyroid cancer (differentiated thyroid carcinoma).
Sorafenib Stada is a so-called multikinase inhibitor. It works by slowing down the growth of cancer cells and cutting off their blood supply, which allows cancer cells to continue growing.

2. Important information before taking Sorafenib Stada

When not to take Sorafenib Stada

• If the patient is allergicto sorafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Sorafenib Stada, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Sorafenib Stada

• If the patient experiences any of the following symptoms, they should contact their doctor immediately, as it may be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue.

Such symptoms may be caused by a group of metabolic complications that can occur during cancer treatment, caused by the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).

• If skin changes occur.Sorafenib Stada may cause rash and skin reactions, especially on the palms of the hands and soles of the feet. These changes can usually be treated by the attending physician. If the changes do not resolve, the doctor may temporarily discontinue treatment with Sorafenib Stada or stop it altogether.
• If the person prescribed the medicine has high blood pressure.Sorafenib Stada may increase blood pressure. The attending physician will check blood pressure and may prescribe medications to lower it if necessary.
• If the patient has or has had an aneurysm(enlargement of a blood vessel and weakening of its wall) or a rupture of the blood vessel wall.
• If the patient has diabetes.In diabetic patients, blood sugar levels should be regularly checked to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of excessive lowering of blood sugar levels.
• If the patient experiences any bleeding or is taking warfarin or fenprocoumon.Treatment with Sorafenib Stada may increase the risk of bleeding. A person taking warfarin or fenprocoumon, which reduce blood clotting to prevent thrombosis, may have an increased risk of bleeding.
• If the patient experiences chest pain or heart problems.The attending physician may decide to temporarily discontinue treatment or stop it altogether.
• If the patient has heart problems,such as abnormal electrical activity, known as "QT interval prolongation".
• If surgery is planned or has recently been performed.Sorafenib Stada may affect wound healing. Sorafenib Stada is usually discontinued in patients before surgery. The attending physician will decide when to resume treatment with Sorafenib Stada.
• If the patient is also taking irinotecan or receiving docetaxel,which are also medicines used to treat cancer. Sorafenib Stada may enhance the effect, especially the side effects of these medicines.
• If the patient is taking neomycin or other antibiotics. The effect of Sorafenib Stada may be reduced.
• If the patient has severe liver dysfunction.In such cases, more serious side effects may occur during treatment.
• If the patient has impaired kidney function.The doctor will monitor fluid and electrolyte balance.
• Fertility. Sorafenib Stada may reduce fertility in both men and women. Any fertility issues should be discussed with the doctor.
• Gastrointestinal perforation.During treatment, a rupture of the gastrointestinal wall may occur (see section 4: Possible side effects). In this case, the doctor will recommend discontinuing treatment.
• If the patient has thyroid cancer, the doctor will monitor calcium and thyroid hormone levels in the blood.
• If the patient experiences any of the following symptoms, they should contact their doctor immediately, as it may be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue.Such symptoms may be caused by a group of metabolic complications that can occur during cancer treatment, caused by the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).

to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).

The patient should inform their doctor if any of the above circumstances

apply to them.In these cases, appropriate treatment may be necessary, and the doctor may decide to change the dose of Sorafenib Stada or discontinue it altogether (see also section 4: Possible side effects).

Children and adolescents

No studies have been conducted on the use of Sorafenib Stada in children and adolescents.

Sorafenib Stada and other medicines

Some medicines may affect the action of Sorafenib Stada, or their action may be changed by Sorafenib Stada. The patient should tell their doctor or pharmacist about any of the following medicines and any other medicines they are currently taking or have recently taken, including those available without a prescription:

• Rifampicin, neomycin, or other antibiotics used to treat infections
• St. John's wort, used to treat depression
• Phenytoin, carbamazepine, or phenobarbital, used to treat epilepsyand other conditions
• Dexamethasone, a corticosteroidused to treat various conditions
• Warfarin or fenprocoumon, anticoagulant medications used to prevent thrombosis
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - anticancer medicines
• Digoxin, used to treat mild to moderate heart failure

Pregnancy and breastfeeding

Pregnancy should be avoided while taking Sorafenib Stada.If there is a possibility that the patient may become pregnant, they should use effective contraception during treatment. If the patient becomes pregnant during treatment with Sorafenib Stada, they should contact their doctor immediately, who will decide whether to continue treatment.
Breastfeeding should not be done while taking Sorafenib Stada,as sorafenib may affect the growth and development of the child.

Driving and operating machinery

There is no data to suggest that Sorafenib Stada may impair the ability to drive or operate machinery.

Sorafenib Stada contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it can be considered a sodium-free product.

3. How to take Sorafenib Stada

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

The recommended dose of Sorafenib Stada for adults is two 200 mg tablets twice daily.

This corresponds to a daily dose of 800 mg, or four tablets.
Sorafenib Stada should be swallowed with a glass of water, on an empty stomach or with meals with low or moderate fat content. The medicine should not be taken with high-fat meals, as this may reduce the effectiveness of Sorafenib Stada. If a high-fat meal is planned, the tablets should be taken at least 1 hour before or 2 hours after the meal.
This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
It is essential to take this medicine at approximately the same time every day to ensure a constant amount of the medicine in the bloodstream.
This medicine is usually taken for as long as it provides clinical benefits and as long as the person taking it does not experience unacceptable side effects.

Taking a higher dose of Sorafenib Stada than recommended

The doctor should be informed immediatelyif the patient (or anyone else) has taken a dose higher than recommended. Taking too much Sorafenib Stada may increase the risk of side effects or worsen them, especially diarrhea and skin reactions. The doctor may recommend discontinuing treatment with this medicine.

Missing a dose of Sorafenib Stada

If the patient misses a dose, they should take it as soon as they remember. If the next dose is due soon, the missed dose should be skipped, and treatment should continue as usual. A double dose should not be taken to make up for a missed single dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sorafenib Stada can cause side effects, although not everyone will experience them. The medicine may also affect the results of some blood tests.

Very common:

May occur in more than 1 in 10 people

• diarrhea
• nausea (nausea)
• feeling of weakness or fatigue (fatigue)
• pain (including pain in the mouth, abdominal pain, headache, bone pain, cancer pain)
• hair loss (alopecia)
• redness or pain on the palms of the hands or soles of the feet (hand-foot syndrome)
• itching or rash
• vomiting
• bleeding (including bleeding into the brain, from the intestinal wall, from the respiratory tract; hemorrhage)
• high blood pressure or periodic increases in blood pressure (hypertension)
• infections
• loss of appetite (anorexia)
• constipation
• joint pain ( arthralgia)
• fever
• weight loss
• dry skin

Common:

May occur in up to 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness in the mouth, tongue pain (oral mucositis 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 in the fingers and toes, including numbness or tingling (peripheral sensory neuropathy)
• depression
• erectile dysfunction (impotence)
• voice changes (dysphonia)
• acne
• skin inflammation, dry and flaky skin (dermatitis, skin exfoliation)
• heart failure
• heart attack (myocardial infarction)or 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 (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste disorders
• sudden redness of the face and often other areas of the skin
• runny nose (rhinitis)
• heartburn (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma/skin cancer)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contractions (muscle spasms)

Uncommon:

May occur in up to 1 in 100 people

• inflammation of the stomach lining
• abdominal pain caused by inflammation of the pancreas, gallbladder, and (or) bile ducts
• yellowing of the skin or eyes (jaundice)caused by high levels of bilirubin ( hyperbilirubinemia)
• allergic reactions (including skin reactions and hay fever)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (lung disease)
• eczema
• overactive thyroid (hyperthyroidism)
• various skin rashes (erythema multiforme)
• high blood pressure
• perforation of the gastrointestinal tract (gastrointestinal perforation)
• reversible posterior leukoencephalopathy, which may be associated with headache, changes in consciousness, seizures, and visual disturbances, including loss of vision (reversible posterior leukoencephalopathy syndrome)
• sudden, severe allergic reaction (anaphylactic reaction)

Rare:

May occur in up to 1 in 1,000 people

• allergic reaction with skin swelling (e.g., face, tongue), which can cause difficulty breathing or swallowing (angioedema)
• heart rhythm disorders (QT interval prolongation)
• inflammation of the liver, which can cause nausea, vomiting, abdominal pain, and jaundice (drug-induced liver inflammation)
• sunburn-like rash, which can occur on skin previously exposed to radiation, and its severity can be severe (radiation recall dermatitis)
• severe skin and (or) mucous membrane reactions, including painful blisters and fever, including widespread skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown, which can lead to kidney problems (rhabdomyolysis)
• kidney damage causing large amounts of protein to be lost (nephrotic syndrome)
• inflammation of the blood vessels in the skin, which can cause a rash (leukocytoclastic vasculitis)

Frequency not known:

cannot be estimated from the available data

• brain disorders, which may be associated with, for example, drowsiness, changes in behavior, or disorientation (encephalopathy)
• enlargement of the blood vessel wall and its weakening or rupture of the blood vessel wall (aneurysms and arterial dissection)
• nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue [tumor lysis syndrome (TLS)] (see section 2).

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 4921 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Sorafenib Stada

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry datestated on the carton after the words: Expiry date (EXP). The expiry date refers to the last day of the month stated.
Aluminum/OPA/Aluminum/PVC blisters:
No special precautions for storage of the medicinal product are necessary.
Aluminum/PVC/PE/PVDC blisters:
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sorafenib Stada contains

• The active substance of the medicine is sorafenib. Each coated tablet contains 200 mg of sorafenib (as tosylate).
• Other ingredients are: Tablet core: hypromellose 2910, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. Tablet coating: hypromellose 2910, titanium dioxide, macrogol, iron oxide red (E172).

What Sorafenib Stada looks like and contents of the pack

Sorafenib Stada 200 mg coated tablets are red-brown, round, biconvex, coated tablets with the number "200" embossed on one side and smooth on the other, with a diameter of approximately 12.0 mm ± 5%.
The medicine is available in packs of 56 and 112 coated tablets in Aluminum/PVC/PE/PVDC blisters in a cardboard box.
The medicine is available in packs of 56 x 1 or 112 x 1 coated tablets in perforated unit dose Aluminum/PVC/PE/PVDC blisters in a cardboard box.
The medicine is available in packs of 60 coated tablets in Aluminum/OPA/Aluminum/PVC blisters.
Not all pack sizes may be marketed.

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

Manufacturer:

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol, Cyprus
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna, Austria
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate, Birzebbugia BBG3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Sorafenib STADA 200 mg, film-coated tablets
Austria
Sorafenib STADA 200 mg Filmtabletten
Belgium
Sorafenib EG 200 mg, film-coated tablets
Czech Republic
Sorafenib STADA
Germany
Sorafenib AL 200 mg Filmtabletten
Denmark
Sorafenib STADA
Spain
Sorafenib STADA 200 mg coated tablets EFG
Finland
Sorafenib STADA 200 mg film-coated tablets
France
SORAFENIB EG 200 mg, film-coated tablets
Croatia
Sorafenib STADA 200 mg film-coated tablets
Hungary
Sorafenib Stada 200mg film-coated tablets
Iceland
Sorafenib STADA 200 mg film-coated tablets
Italy
SORAFENIB EG
Luxembourg
Sorafenib EG 200 mg, film-coated tablets
Norway
Sorafenib STADA
Portugal
Sorafenib Stada
Romania
Sorafenib Stada 200mg film-coated tablets
Sweden
Sorafenib STADA 200 mg film-coated tablets
Slovakia
Sorafenib STADA
Date of last revision of the leaflet:08/2024