Package leaflet: Information for the patient

Sorafenib Sandoz, 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, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

Sorafenib Sandoz is used in the treatment of liver cancer (hepatocellular carcinoma).
Sorafenib Sandoz is also used in the treatment of advanced kidney cancer
(advanced renal cell carcinoma) in patients who have not responded to standard therapy in terms of disease control or for whom such therapy is considered inappropriate.
Sorafenib Sandoz is used in the treatment of thyroid cancer (differentiated thyroid carcinoma).
Sorafenib Sandoz is a so-called multikinase inhibitor. It works by slowing down the growth of cancer cells and cutting off the blood supply that supports the development of cancer cells.

2. Important information before using Sorafenib Sandoz

When not to use Sorafenib Sandoz

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

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

If skin changes occur. Sorafenib Sandoz may cause skin rash and skin reactions, especially on the palms of the hands and soles of the feet. Usually, these changes can be managed by your treating doctor. If they do not resolve, your doctor may temporarily interrupt treatment with Sorafenib Sandoz or discontinue it completely.
If the patient has high blood pressure. Sorafenib Sandoz may increase blood pressure. Your treating doctor will monitor your blood pressure and may prescribe medications to lower it.
If the patient has or has previously had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the blood vessel wall.
If the patient has diabetes. In patients with diabetes, blood sugar levels should be monitored regularly to determine whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of low blood sugar levels.
If any bleeding disorders occur or if the patient is taking warfarin or phenprocoumon. Treatment with Sorafenib Sandoz may increase the risk of bleeding. If the patient is taking warfarin or phenprocoumon, anticoagulant medicines used to prevent blood clots, there may be an increased risk of bleeding.
If chest pain or heart problems occur, the doctor may decide to temporarily interrupt treatment with Sorafenib Sandoz or discontinue it completely.
If heart-related problems occur, such as abnormal electrical activity, known as "prolongation of the QT interval."
If the patient is scheduled for surgery or has recently undergone surgery. Sorafenib Sandoz may affect wound healing. Usually, Sorafenib Sandoz is discontinued prior to surgery. Your treating doctor will decide when to resume treatment with Sorafenib Sandoz.
If the patient is taking irinotecan or receiving docetaxel, which are also medicines used to treat cancer. Sorafenib Sandoz may enhance their effects, particularly their adverse effects.
If the patient is taking neomycin or other antibiotics, the effectiveness of Sorafenib Sandoz may be reduced.
If the patient has severe liver function impairment, more severe adverse reactions may occur during treatment.
If the patient has kidney function disorders, the doctor will monitor fluid and electrolyte balance.
Fertility. Sorafenib Sandoz may reduce fertility in both men and women. Any fertility-related concerns should be discussed with your doctor.
Perforation of the gastrointestinal tract (gastrointestinal perforation) may occur during treatment (see section 4: Possible side effects). In such a case, the doctor will recommend discontinuation of treatment.
If the patient has thyroid cancer, the doctor will monitor blood calcium and thyroid hormone levels.
If the patient experiences any of the following symptoms, contact the doctor immediately, as these 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 due to the breakdown products of 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 any of these situations apply to the patient, inform the doctor. Treatment may be required, or the doctor may decide to adjust the dose of Sorafenib Sandoz or discontinue treatment completely (see also section 4: Possible side effects).
Children and adolescents
Studies on the use of Sorafenib Sandoz in children and adolescents have not been conducted.
Sorafenib Sandoz and other medicines
Some medicines may affect the action of Sorafenib Sandoz, or their action may be altered by Sorafenib Sandoz. Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, including those the patient plans to use, as well as any other medicines, 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
Pregnancy should be avoided during treatment with Sorafenib Sandoz. If there is a risk that the
patient may become pregnant while taking Sorafenib Sandoz, an effective method of contraception should be used during treatment. If the patient becomes pregnant while taking Sorafenib Sandoz, she should immediately inform her treating doctor, who will decide whether treatment may continue.
Breastfeeding is not allowed during treatment with Sorafenib Sandoz, as this medicine may affect the child's growth and development.
Driving and operating machinery
There are no data on the effects of Sorafenib Sandoz on the ability to drive and operate machinery.
Sodium content of Sorafenib Sandoz.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free."

3. How to take Sorafenib Sandoz

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended dose of Sorafenib Sandoz for adults is 2 tablets x 200 mg, taken twice daily.
This corresponds to a daily dose of 800 mg or 4 tablets.
Sorafenib Sandoz should be swallowed with a glass of water, on an empty stomach or with a meal low or
moderately high in fat. Do not take the medicine with a high-fat meal, as this may reduce the effectiveness of Sorafenib Sandoz. If a high-fat meal is planned, the tablets should be taken at least 1 hour before or 2 hours after the meal.
It is important to take this medicine at approximately the same time each day to maintain a consistent level of the drug 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 Sandoz than prescribed
Contact your doctor immediately if the patient (or anyone else) has taken more than the prescribed dose. Taking too much Sorafenib Sandoz may increase the likelihood or severity of side effects, especially diarrhea and skin reactions. The doctor may advise stopping treatment with this medicine.
Missing a dose of Sorafenib Sandoz
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and treatment should continue as before. Do not take a double dose to make up for a missed single dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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
nausea (feeling sick)
feeling weak or tired (fatigue)
pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain)
hair loss (alopecia)
redness or pain in hands or feet (hand-foot syndrome)
itching or rash
vomiting
bleeding (including brain haemorrhage, intestinal wall bleeding, respiratory tract bleeding, 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
low number of white blood cells (lymphocytes)
low phosphate levels in blood
increased activity of amylase (a digestive enzyme)
increased activity of lipase (a digestive enzyme)

Common:
May affect up to 1 in 10 people

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

Uncommon:
May affect up to 1 in 100 people

inflammation of the lining of the stomach
abdominal pain caused by inflammation of the pancreas, inflammation of the gallbladder and/or bile ducts
yellowing of the skin or eyes (jaundice) due to high levels of bile pigments (hyperbilirubinaemia)
allergic reactions (including skin reactions and hay fever)
dehydration
breast enlargement (gynaecomastia)
breathing difficulties (lung disease)
rash (eczema)
increased thyroid activity (hyperthyroidism)
multiple skin lesions (erythema multiforme)
abnormally high blood pressure
perforation of the intestinal wall (gastrointestinal perforation)
reversible swelling of the posterior part of the brain, which may be associated with headache, altered consciousness, seizures and visual disturbances, including loss of vision (reversible posterior leukoencephalopathy)
sudden, severe allergic reaction (anaphylactic reaction)
transient increase in activity of enzymes related to the liver or bones
changes in blood coagulation
changes in blood coagulation (abnormal prothrombin concentration)

Rare:
May affect up to 1 in 1000 people

allergic reaction with swelling of the skin (e.g. face, tongue), which may cause difficulty breathing or swallowing (angioedema)
irregular heart rhythm (QT interval prolongation)
hepatitis, which may cause nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
sunburn-type rash, which may occur on skin previously treated with radiotherapy and may be severe (radiation dermatitis)
severe skin and/or mucosal reactions, which may include painful blisters and fever, including extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
abnormal breakdown of muscle tissue, which may lead to kidney dysfunction (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 available data

brain function disorders, which may be associated with, for example, drowsiness, changes in behaviour or disorientation (encephalopathy)
enlargement and weakening of blood vessel wall or blood vessel wall tear (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 adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301 / Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sorafenib Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
the blister after EXP. The expiry date refers to the last day of the stated month.
Aluminium/OPA/Aluminium/PVC foil blisters:
No special requirements for the storage conditions of this medicinal product.
Aluminium/PVC/PE/PVDC foil blisters:
Do not store above 30°C.
Medicines should not be disposed of via the sewage system or household waste. You should ask
your pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Sorafenib Sandoz contains

The active substance is sorafenib. Each coated tablet contains 200 mg of sorafenib (as sorafenib tosylate).
The other ingredients are: hypromellose 2910, sodium croscarmellose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. Coating: hypromellose 2910, titanium dioxide, macrogol, iron oxide red (E 172).

What Sorafenib Sandoz looks like and contents of the pack
Reddish-brown, round, biconvex coated tablets with the inscription
"200" embossed on one side and smooth on the other, with a diameter of 12.0 mm ± 5%.
The medicine is available in packs containing 112 coated tablets in blisters made of
Aluminium/PVC/PE/PVDC, packed in a cardboard box.
The medicine is also available in packs containing 112 x 1 coated tablets in single-dose perforated blisters made of
Aluminium/PVC/PE/PVDC, packed in a cardboard box.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
LEK Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus

PharOS MT Ltd.
HF62X Hal Far Industrial Estate
Birzebbugia BBG3000
Malta

For more detailed information about the medicinal product, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Netherlands Sorafenib Sandoz 200 mg, film-coated tablets
Austria Sorafenib Sandoz 200 mg – Film-coated tablets
Belgium Sorafenib Sandoz 200 mg film-coated tablets
Bulgaria Sorafenib Sandoz 200 mg film coated tablet
Cyprus Sorafenib PharOS Generics 200 mg film-coated tablets
Czech Republic Sorafenib Sandoz
Germany Sorafenib HEXAL 200 mg Film-coated tablets
Denmark Sorafenib Sandoz
Estonia Sorafenib Sandoz
Spain Sorafenib Sandoz 200 mg film-coated tablets
Finland Sorafenib Sandoz 200 mg film-coated tablets
France SORAFENIB SANDOZ 200 mg, film-coated tablet
Greece Sorafenib/Sandoz
Croatia Sorafenib Sandoz 200 mg film-coated tablets
Hungary Sorafenib Sandoz 200 mg film-coated tablet
Italy Sorafenib Sandoz
Lithuania Sorafenib Sandoz 200 mg film-coated tablets
Latvia Sorafenib Sandoz 200 mg film-coated tablets
Poland Sorafenib Sandoz
Portugal Sorafenib Sandoz
Romania Sorafenib Sandoz 200 mg film-coated tablets
Sweden Sorafenib Sandoz 200 mg film-coated tablets
Slovenia Sorafenib Sandoz 200 mg film-coated tablets
Slovakia Sorafenib Sandoz 200 mg
Northern Ireland Sorafenib Sandoz 200 mg film-coated tablets