Sorafenib Stada

Package Leaflet: Information for the User

Sorafenib STADA, 400 mg, film-coated tablets

sorafenib

Read all of this leaflet carefully before 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 and other information

• 1. What Sorafenib STADA is and what it is used for
• 2. Before you take 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 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 a so-called multi-kinase inhibitor. It works by reducing the rate of growth of cancer cells and cutting off the blood supply that supports tumor growth.

2. Before you take Sorafenib STADA

When not to take Sorafenib STADA

• if you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Before taking Sorafenib STADA, discuss it with your doctor or pharmacist.

When to be extra careful while taking Sorafenib STADA

• -If you experience any of the following symptoms, contact your doctor immediately, as it may be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle spasms, seizures, cloudy urine, and fatigue. These 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 can lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).
• If you experience skin changes. Sorafenib STADA may cause rash and skin reactions, especially on the palms of your hands and soles of your feet. These changes can usually be treated by your doctor. If they do not improve, your doctor may temporarily stop treatment with Sorafenib STADA or discontinue it altogether.
• If you have high blood pressure. Sorafenib STADA may increase blood pressure. Your doctor will check your blood pressure and may give you medication to lower it if necessary.
• 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.In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of low blood sugar.
• If you experience any bleeding or are taking warfarin or fenprocoumon.Treatment with Sorafenib STADA may increase the risk of bleeding. People taking warfarin or fenprocoumon, which reduce blood clotting to prevent thrombosis, may have an increased risk of bleeding.
• If you experience chest pain or heart problems, your doctor may decide to stop treatment or discontinue it altogether.
• If you experience heart problems, such as abnormal heart rhythm, known as "QT interval prolongation".
• If you are scheduled for surgery or have recently undergone surgery. Sorafenib STADA may affect wound healing. Treatment with Sorafenib STADA is usually stopped in case of surgery. Your doctor will decide when to resume treatment with Sorafenib STADA.
• If you are taking irinotecan or docetaxel, which are also cancer medicines. Sorafenib STADA may enhance their effects, especially side effects.
• If you are taking neomycin or other antibiotics, the effectiveness of Sorafenib STADA may be reduced.
• If you have severe liver dysfunction, more serious side effects may occur during treatment.
• In case of impaired kidney function, your doctor will monitor your fluid and electrolyte balance.
• Fertility.Sorafenib STADA may reduce fertility in both men and women. Any fertility issues should be discussed with your doctor.
• Gastrointestinal perforation.During treatment, a rupture of the gastrointestinal wall may occur (see also section 4: Possible side effects). In this case, your doctor will advise you to stop treatment.

Tell your doctor if any of the above applies to you

before taking Sorafenib STADA.In these cases, appropriate treatment may be necessary, and your doctor may decide to change the dose of Sorafenib STADA or stop treatment 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 may have their action changed by Sorafenib STADA. Tell your doctor or pharmacist about any of the following medicines and any other medicines you are taking now or have recently taken, as well as any medicines you plan to take, 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 epilepsy and other conditions
• Dexamethasone, a corticosteroid used in various diseases
• Warfarin or fenprocoumon, anticoagulant medications used to prevent thrombosis
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - anticancer medications
• Digoxin, used to treat mild to moderate heart failure

Pregnancy and breastfeeding

Women should avoid becoming pregnant while taking Sorafenib STADA. If there is a possibility that the patient may become pregnant, she should use effective contraception during treatment. If the patient becomes pregnant during treatment, she should contact her doctor immediately, who will decide whether to continue treatment.
Do not breastfeed while taking Sorafenib STADA, as sorafenib may affect the growth and development of the child.

Driving and using machines

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

Sorafenib STADA contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Sorafenib STADA

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose of Sorafenib STADA for adults is 400 mg twice a day.

This corresponds to a daily dose of 800 mg or two tablets.
Sorafenib STADA should be taken with a glass of water, on an empty stomach or with a meal with low or moderate fat content. Do not take the medicine with high-fat meals, as it may reduce the effectiveness of Sorafenib STADA. If you plan to have a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
It is important to take this medicine at the same time every day to ensure a constant amount of medicine in the bloodstream.
The score line on the tablet is only to help you break the tablet if you have difficulty swallowing it whole.
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

Tell your doctor immediatelyif you (or anyone else) have taken a higher dose of Sorafenib STADA than recommended. Taking too much Sorafenib STADA may increase the risk of side effects or make them worse, especially diarrhea and skin reactions. Your doctor may advise you to stop treatment with this medicine.

Missing a dose of 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, skip the missed dose and continue treatment as before. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Sorafenib STADA 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
• nausea (vomiting)
• feeling weak or tired (fatigue)
• pain (including pain in the mouth, abdominal pain, bone pain, headache, tumor pain)
• hair loss (alopecia)
• redness or pain on the palms of your hands or soles of your feet (hand-foot syndrome)
• itching or rash
• vomiting
• bleeding (including cerebral hemorrhage, gastrointestinal bleeding, respiratory bleeding, 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 affect up to 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness of the mouth, tongue pain (stomatitis and mucositis)
• 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
• skin inflammation, dry and flaky skin (dermatitis and desquamation)
• 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)
• hair follicle inflammation (folliculitis)
• underactive thyroid gland (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste disturbances (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinitis)
• heartburn (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma/skin carcinoma)
• 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 hay fever)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (respiratory disease)
• eczema
• overactive thyroid gland (hyperthyroidism)
• various skin rashes (erythema multiforme)
• very high blood pressure
• perforation of the gastrointestinal tract (gastrointestinal perforation)
• reversible brain swelling, which may be associated with headache, changes in consciousness, seizures, and vision disturbances, including loss of vision (reversible posterior leukoencephalopathy syndrome)
• sudden, severe allergic reaction (anaphylactic reaction)

Unknown(frequency cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sorafenib STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sorafenib STADA contains

• The active substance is sorafenib. Each tablet contains 400 mg of sorafenib (as tosylate)
• The other ingredients are: Tablet: hypromellose 2910 (E464), croscarmellose sodium, microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate Coating:hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521)

What Sorafenib STADA looks like and contents of the pack

Oval, white to off-white film-coated tablets with a score line on one side and flat on the other, 20.1 mm x 10.1 mm ± 5%.
Blisters of aluminum-OPA/Alu/PVC containing: 28, 30, 56, 60, bulk packaging 84 (3 packages of 28), bulk packaging 112 (4 packages of 28), bulk packaging 120 (4 packages of 30) film-coated tablets. Blisters of aluminum-OPA/Alu/PVC divided into single doses containing: 28 x 1, 30 x 1, 56 x 1, 60 x 1, bulk packaging 84 x 1 (3 packages of 28 x 1), bulk packaging 112 x 1 (4 packages of 28 x 1), bulk packaging 120 x 1 (4 packages of 30 x 1) film-coated tablets.

• Not all pack sizes may be marketed.

No images were present in the original text to translate.

Marketing authorization holder and manufacturer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer:

• 1. Remedica Ltd Aharnon Street, Limassol Industrial Estate Limassol, 3056, Cyprus
• 2. PharOS MT Ltd HF62X, Hal Far Industrial Estate Birzebbugia

BBG3000, Malta

• 3. STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany

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

Sorafenib STADA Arzneimittel 400 mg, filmomhulde tabletten

Netherlands

Sorafenib STADA

Czech Republic, Poland

Sorafenib STADA 400 mg Filmtabletten

Germany

Sorafenib STADA 400 mg comprimidos recubiertos con película

Spain
Croatia

Sorafenib STADA 400 mg filmom obložene tablete

Hungary

SORAFENIB STADA 400 mg filmtabletta

Romania

SORAFENIB STADA 400 mg comprimate filmate

Sorafenib EG 400 mg

Belgium,
Luxembourg
Date of last revision of the leaflet:03/2023