Sorafenib sandoz

Package leaflet: Information for the patient

Sorafenib Sandoz, 400 mg, film-coated tablets
Sorafenibum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Sorafenib Sandoz is and what it is used for
2. What you need to know before taking Sorafenib Sandoz
3. How to take Sorafenib Sandoz
4. Possible side effects
5. How to store Sorafenib Sandoz
6. 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 stage kidney cancer
(advanced renal cell carcinoma) in patients in whom standard therapy has failed to halt disease progression or is considered inappropriate.
Sorafenib Sandoz is a so-called multi-kinase inhibitor. It works by reducing the rate of cancer cell growth and by 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 with Sorafenib Sandoz:

• If skin changes occur. Sorafenib Sandoz may cause rash and skin reactions, especially on the palms of the hands and soles of the feet. These changes can usually be managed by your 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 doctor will monitor your blood pressure and may prescribe medications to lower it.

• If the patient experiences any of the following symptoms, contact your 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 products released from dying tumor cells [tumor lysis syndrome (TLS)], which may lead to impaired kidney function and acute kidney failure (see also section 4. Possible side effects).

• If the patient has or has previously had an aneurysm (a weakened and bulging 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 determine whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of low blood sugar.

• 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 drugs used to prevent blood clots, the risk of bleeding may be increased.

• If chest pain or heart problems occur, the doctor may decide to temporarily interrupt or permanently discontinue treatment with Sorafenib Sandoz.

• If heart-related problems occur, such as abnormal electrical activity known as "QT interval prolongation."

• 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 doctor will decide when to resume treatment with Sorafenib Sandoz.

• If the patient is taking irinotecan or receiving docetaxel, which are also anticancer drugs. 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 impairment, the doctor will monitor fluid and electrolyte balance.

• Fertility. Sorafenib Sandoz may reduce fertility in both men and women. Any concerns regarding fertility should be discussed with your doctor.

• Gastrointestinal perforation (a hole in the wall of the digestive tract) may occur during treatment (see section 4: Possible side effects). In such a case, the doctor will recommend discontinuing treatment.

If any of these situations apply to the patient, inform your doctor. Treatment may need to be adjusted, or your doctor may decide to change 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 yet been conducted.
Sorafenib Sandoz and other medicines
Some medicines may affect the action of Sorafenib Sandoz, or their effects may be altered by Sorafenib Sandoz. Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken from this list, as well as any medicines the patient plans 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 conditions
• 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 must 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 a patient becomes pregnant while taking Sorafenib Sandoz, she must inform her doctor immediately. The doctor will decide whether treatment may continue.
Breastfeeding is not allowed during treatment with Sorafenib Sandoz, as this medicine may affect the growth and development of the child.
Driving and operating machinery
There are no data available on the effects of Sorafenib Sandoz on the ability to drive or 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 use Sorafenib Sandoz

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose of Sorafenib Sandoz in adults is 400 mg twice daily.
This corresponds to a daily dose of 800 mg or 2 tablets.
Sorafenib Sandoz should be swallowed with a glass of water, on an empty stomach or with a low- or
moderately fat-containing meal. Do not take this medicine with high-fat meals,
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.
This medicine should always be taken as prescribed by your doctor. If you have any doubts,
you should 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.
The break line on the tablet is intended only to facilitate tablet division for easier swallowing and does not indicate equal dosing.
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
You should immediately inform your doctor if the patient (or anyone else) has taken more than the prescribed dose.
Taking too much Sorafenib Sandoz may increase the likelihood of adverse effects or make them more severe, especially diarrhea and skin reactions.
Your 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 close to the time for the next dose, the missed dose should be skipped and treatment should continue as previously scheduled. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
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 of weakness or tiredness (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 cerebral haemorrhage, intestinal wall bleeding, respiratory tract bleeding, haemorrhage)
• increased blood pressure or periodic rises 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 in 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 symptoms, dry and flaky 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 platelet count (thrombocytopenia)
• folliculitis
• reduced thyroid activity (hypothyroidism)
• low sodium levels in the blood (hyponatraemia)
• taste disturbances
• redness of the face and often other skin areas (flushing)
• watery nasal discharge (watery rhinitis)
• heartburn (gastro-oesophageal reflux disease)
• skin cancer (squamous cell carcinoma/skin squamous cell carcinoma)
• thickening of the outer skin layer (hyperkeratosis)
• sudden, involuntary muscle cramps (muscle spasms)

Uncommon:
May occur in not more than 1 in 100 people

• inflammation of the stomach lining
• abdominal pain caused by pancreatitis, inflammation of the 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)
• skin rash (eczema)
• increased thyroid activity (hyperthyroidism)
• multiple skin lesions (erythema multiforme)
• abnormally high blood pressure
• intestinal wall perforation (gastrointestinal perforation)
• reversible swelling of the brain's posterior region, 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)

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)
• irregular heart rhythm (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 radiation therapy, and may be severe (radiation dermatitis)
• severe skin and/or mucosal reactions, which may include painful blisters and fever, including extensive skin detachment (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 (leukocytoclastic vasculitis)

Frequency not known:
Frequency cannot be estimated from available data

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this 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 outer carton and blister marked EXP. The expiry date refers to the last day of the stated month.
There are no special requirements for storage conditions of this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so 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 400 mg of sorafenib (as sorafenib tosylate).
• The other ingredients are: hypromellose 2910, sodium croscarmellose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. Coating of the tablet: hypromellose 2910, titanium dioxide (E 171), macrogol 3350.

What Sorafenib Sandoz looks like and contents of the pack
White or almost white, oval coated tablets with a break line on one side and smooth on the other, measuring 20.1 mm x 10.1 mm ± 5%.
The medicine is available in aluminium/OPA/aluminium/PVC blisters containing 56 coated tablets and in perforated unit dose aluminium/OPA/aluminium blisters containing 56 x 1 tablet.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
PharOS MT Ltd
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

For more detailed information about this medicine, 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 in the Member States of the European Economic Area under the following names:
Netherlands Sorafenib Sandoz 400 mg, filmomhulde tabletten
Austria Sorafenib Sandoz 400 mg – Filmtabletten
Belgium Sorafenib Sandoz 400 mg filmomhulde tabletten
Czech Republic Sorafenib Sandoz
Germany Sorafenib HEXAL 400 mg Filmtabletten
Denmark Sorafenib Sandoz
Estonia Sorafenib Sandoz
Greece Sorafenib/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία
Spain Sorafenib Sandoz 400 mg comprimidos recubiertos con película EFG
Croatia Sorafenib Sandoz 400 mg filmom obložene tablete
Hungary Sorafenib Sandoz 400 mg filmtabletta
Lithuania Sorafenib Sandoz 400 mg plėvele dengtos tabletės
Latvia Sorafenib Sandoz 400 mg plēvelē pārklātas tabletes
Poland Sorafenib Sandoz
Portugal Sorafenib Sandoz
Romania Sorafenib Sandoz 400 mg comprimate filmate
Slovakia Sorafenib Sandoz 400 mg