Package leaflet: Information for the patient

Sorafenib Stada, 200 mg, coated tablets
Sorafenibum
Please 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 a specific person. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Sorafenib Stada is and what it is used for
What you need to know before taking Sorafenib Stada
How to take Sorafenib Stada
Possible side effects
How to store Sorafenib Stada
Contents of the pack and other information

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

Sorafenib Stada is used in the treatment of liver cancer (hepatocellular carcinoma).
Sorafenib Stada is also used in the treatment of advanced kidney cancer (advanced renal cell carcinoma) in patients in whom standard therapy has not been effective in halting the disease or is considered inappropriate. Sorafenib Stada is used in the treatment of thyroid cancer (differentiated thyroid carcinoma).
Sorafenib Stada is a so-called multi-kinase inhibitor. It works by slowing down the growth of cancer cells and by cutting off their blood supply, which is necessary for cancer cells to continue growing.

2. Important information before taking Sorafenib Stada

When not to use Sorafenib Stada

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

Warnings and precautions
Before starting treatment with Sorafenib Stada, discuss this with your doctor or
pharmacist.
When to exercise special caution when taking Sorafenib Stada

If the following symptoms occur, contact your doctor immediately, as they may indicate a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue.

These symptoms may be caused by a group of metabolic complications that can occur during cancer treatment, resulting from products released by dying tumor 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, particularly on the palms of the hands and soles of the feet. These changes can usually be managed by the treating physician. If symptoms persist, your doctor may temporarily interrupt treatment with Sorafenib Stada or discontinue it completely.
If the person prescribed the medicine has high blood pressure. Sorafenib Stada may increase blood pressure. Your treating doctor will monitor your blood pressure values and may prescribe antihypertensive medications if necessary.
If the patient has or has had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
If the patient has diabetes. Blood glucose levels should be monitored regularly in patients with diabetes to assess whether the dose of antidiabetic medication needs adjustment to minimize the risk of excessively low blood sugar levels.
If any bleeding occurs or if the patient is taking warfarin or phenprocoumon. Treatment with Sorafenib Stada may increase the risk of bleeding. Patients taking warfarin or phenprocoumon, which reduce blood clotting to prevent thrombosis, may have an increased risk of bleeding.
If chest pain or heart problems occur. The treating doctor may decide to temporarily interrupt treatment or discontinue it completely.
If the patient has heart disorders, 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 before surgical procedures. Your treating doctor will decide when it is safe to resume treatment with Sorafenib Stada.
If the patient is also taking irinotecan or receiving docetaxel, which are also anticancer medicines. Sorafenib Stada may enhance the effects, and especially the side effects, of these drugs.
If the patient is taking neomycin or other antibiotics. The effect of Sorafenib Stada may be reduced.
If the patient has severe liver function impairment. In such cases, more severe adverse reactions may occur during treatment.
If the patient has impaired kidney function. Your doctor will monitor fluid and electrolyte balance.
Fertility. Sorafenib Stada may reduce fertility in both men and women. Discuss any fertility-related concerns with your doctor.
Gastrointestinal perforation. During treatment, a break in the continuity of the gastrointestinal tract wall may occur (see section 4: Possible side effects). In such cases, your doctor will recommend discontinuing treatment.
If the patient has thyroid cancer, the doctor will monitor blood calcium and thyroid hormone levels.
If the following symptoms occur, contact your doctor immediately, as they may indicate a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These symptoms may be caused by a group of metabolic complications that can occur during cancer treatment, resulting from products released by dying tumor cells [tumor lysis syndrome (TLS)], and may lead to

kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).
Inform your doctor if any of the above conditions apply to you. In such cases, appropriate treatment may be required, and your doctor may decide to adjust the dose of Sorafenib Stada or discontinue treatment completely (see also section 4: Possible side effects).
Children and adolescents
Studies on the use of Sorafenib Stada in children and adolescents have not yet been conducted.
Sorafenib Stada and other medicines
Some medicines may affect the action of Sorafenib Stada, or their effects may be altered by Sorafenib Stada. Inform your doctor or pharmacist about any of the medicines listed below, as well as any other medicines you are currently taking or have recently taken, and any medicines you plan to take, including over-the-counter medicines:

Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
St. John’s wort, used in the treatment of depression
Phenytoin, carbamazepine, or phenobarbital, medicines used in epilepsy and other disorders
Dexamethasone, a corticosteroid used in various diseases
Warfarin or phenprocoumon, anticoagulant medicines used to prevent blood clots
Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan – anticancer medicines
Digoxin, used in the treatment of mild to moderate heart failure

Pregnancy and breastfeeding
Avoid becoming pregnant while taking Sorafenib Stada. If there is any possibility that the patient could become pregnant, an effective method of contraception should be used during treatment. If a patient becomes pregnant while being treated with Sorafenib Stada, she should contact her doctor immediately to determine whether treatment should continue.
Breastfeeding is not allowed during treatment with Sorafenib Stada, as sorafenib may affect the growth and development of the child.
Driving and operating machinery
There are no data indicating 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, meaning it is essentially considered sodium-free.

3. How to use Sorafenib Stada

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
The recommended dose of Sorafenib Stada for adults is two tablets of 200 mg twice daily.
This corresponds to a daily dose of 800 mg, i.e. four tablets.
Sorafenib Stada tablets should be swallowed with a glass of water, on an empty stomach or together with a low- or moderately fat-containing meal. This 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 prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.
It is important to take this medicine at approximately the same time each day to ensure a constant level of the medicine in the bloodstream.
This medicine is usually taken for as long as it provides clinical benefit and as long as the patient does not experience unacceptable side effects.
Taking more Sorafenib Stada than recommended
Immediately inform the doctor if the patient (or anyone else) has taken more than the recommended dose. Taking too much Sorafenib Stada may increase the risk of side effects or make them more severe, especially diarrhea and skin reactions. The doctor may advise stopping treatment with this medicine.
Missing a dose of Sorafenib Stada
If a patient misses a dose, it should be taken as soon as remembered. If the time for the next dose is approaching, the missed dose should be skipped and treatment continued as before. Do not take a double dose to make up for a missed single dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common:
May occur in more than 1 in 10 people

diarrhoea
nausea (feeling sick)
feeling weak or tired (fatigue)
pain (including mouth pain, abdominal pain, headache, bone pain, tumour-related pain)
hair loss (alopecia)
redness or pain in the palms of the hands or soles of the feet (hand-foot syndrome)
itching or rash
vomiting
bleeding (including bleeding into the brain, intestinal wall, or respiratory tract; haemorrhage)
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 not more than 1 in 10 people

flu-like symptoms
indigestion (dyspepsia)
difficulty swallowing (dysphagia)
inflammation or dryness of the mouth, tongue pain (stomatitis and mucosal inflammation)
low calcium levels in the blood (hypocalcaemia)
low potassium levels in the blood (hypokalaemia)
low blood sugar levels (hypoglycaemia)
muscle pain (myalgia)
sensory disturbances in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
depression
erectile dysfunction (impotence)
voice changes (dysphonia)
acne
skin inflammation, dry and flaky skin (dermatitis, skin desquamation)
heart failure
heart attack (myocardial infarction) or chest pain
ringing in the ears (tinnitus)
kidney failure
abnormally high levels of protein in the urine (proteinuria)
general weakness or loss of strength (asthenia)
reduced number of white blood cells (leukopenia and neutropenia)
reduced number of red blood cells (anaemia)
low platelet count (thrombocytopenia)
inflammation of hair follicles (folliculitis)
reduced thyroid activity (hypothyroidism)
low sodium levels in the blood (hyponatraemia)
taste disturbances
sudden redness of the face and often other areas of skin
watery nasal discharge (watery rhinitis)
heartburn (gastroesophageal reflux disease)
skin tumours (squamous cell carcinoma / cutaneous squamous cell carcinoma)
thickening of the outer layer of the skin (excessive skin keratinisation)
sudden, involuntary muscle cramps (muscle cramps)

Uncommon:
May occur in not more than 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) due to high levels of bile pigments (hyperbilirubinemia)
allergic reactions (including skin reactions and hay fever)
dehydration
breast enlargement (gynaecomastia)
breathing difficulties (lung disease)
rash (eczema)
increased thyroid activity (hyperthyroidism)
various skin eruptions (erythema multiforme)
abnormally high blood pressure
perforation of the intestinal wall (gastrointestinal perforation)
reversible swelling of the back part of the brain, which may be associated with headache, altered consciousness, seizures, and vision disturbances, including loss of vision (reversible posterior leukoencephalopathy syndrome)
sudden, severe allergic reaction (anaphylactic reaction)

Rare:
May occur in not more than 1 in 1,000 people

allergic reaction with skin swelling (e.g. face, tongue), which may cause difficulty breathing or swallowing (angioedema)
heart rhythm disorders (QT interval prolongation)
liver inflammation, which may cause nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
sunburn-like rash, which may occur on skin previously exposed to radiotherapy, and may be severe (radiation recall dermatitis)
severe skin and/or mucosal reactions, including painful blisters and fever, and extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
abnormal breakdown of muscle, 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 (leukocytoclastic vasculitis)

Frequency not known: cannot be estimated from available data

brain function disorders, which may be associated with drowsiness, changes in behaviour or disorientation (encephalopathy)
widening of the blood vessel wall and weakening or tearing of the blood vessel wall (aneurysm and arterial dissection)
nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine and fatigue [tumour lysis syndrome (TLS)] (see section 2).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you 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 stated on the carton after
the words: Expiry date (EXP). The expiry date refers to the last day of the
specified month.
Aluminium/OPA/Aluminium/PVC foil blisters:
No special storage conditions required for this medicinal product.
Aluminium/PVC/PE/PVDC foil blisters:
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sorafenib Stada contains

The active substance is sorafenib. Each coated tablet contains 200 mg of sorafenib (as tosylate).
Other ingredients are:
Tablet core: hypromellose 2910, sodium croscarmellose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate.
Tablet coating: hypromellose 2910, titanium dioxide, macrogol, red iron oxide (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 plain 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 blisters made of Aluminium/PVC/PE/PVDC, packed in a cardboard box.
The medicine is also available in packs of 56 x 1 or 112 x 1 coated tablets in single-dose perforated blisters made of Aluminium/PVC/PE/PVDC, packed in a cardboard box.
The medicine is also available in packs of 60 coated tablets in blisters made of Aluminium/OPA/Aluminium/PVC.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

Manufacturers:
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 authorised for marketing in the following European Economic Area countries under the following names:
Netherlands: Sorafenib STADA 200 mg, filmomhulde tabletten
Austria: Sorafenib STADA 200 mg Filmtabletten
Belgium: Sorafenib EG 200 mg, filmomhulde tabletten
Czech Republic: Sorafenib STADA
Germany: Sorafenib AL 200 mg Filmtabletten
Denmark: Sorafenib STADA
Spain: Sorafenib STADA 200 mg comprimidos recubiertos con película EFG
Finland: Sorafenib STADA 200 mg kalvopäällysteiset tabletit
France: SORAFENIB EG 200 mg, comprimé pelliculé
Croatia: Sorafenib STADA 200 mg filmom obložene tablete
Hungary: Sorafenib Stada 200mg filmtabletta
Iceland: Sorafenib STADA 200 mg filmuhúðaðar töflur
Italy: SORAFENIB EG
Luxembourg: Sorafenib EG 200 mg, comprimés pelliculés
Norway: Sorafenib STADA
Portugal: Sorafenib Stada
Romania: Sorafenib Stada 200mg comprimate filmate
Sweden: Sorafenib STADA 200 mg filmdragerade tabletter
Slovakia: Sorafenib STADA