Sorafenib Sandoz

Package Leaflet: Information for the Patient

Sorafenib Sandoz, 400 mg, Film-Coated Tablets

Sorafenib

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 Package Leaflet

• 1. What is Sorafenib Sandoz and What is it Used For
• 2. Before You Take Sorafenib Sandoz
• 3. How to Take Sorafenib Sandoz
• 4. Possible Side Effects
• 5. How to Store Sorafenib Sandoz
• 6. Contents of the Package and Other Information

1. What is Sorafenib Sandoz and What is it Used For

Sorafenib Sandoz is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Sandoz 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 Sandoz is a so-called multi-kinase inhibitor. It works by reducing the growth rate of cancer cells and cutting off the blood supply that supports tumor growth.

2. Before You Take Sorafenib Sandoz

When Not to Take Sorafenib Sandoz

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

Warnings and Precautions

Before starting treatment with Sorafenib Sandoz, you should discuss it with your doctor or pharmacist.

When to be Extra Careful When Taking Sorafenib Sandoz:

• If you have skin changes. Sorafenib Sandoz 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 go away, your doctor may temporarily stop treatment with Sorafenib Sandoz or stop it altogether.
• If you have high blood pressure. Sorafenib Sandoz may increase blood pressure. Your doctor will monitor your blood pressure and may give you medication to lower it.
• If you experience any of the following symptoms, you should 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).

and can lead to kidney dysfunction and acute kidney failure (see also section 4. Possible Side Effects).

• 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 anti-diabetic medication needs to be adjusted to minimize the risk of low blood sugar.
• If you experience any bleeding disorders or if you are taking warfarin or phenprocoumon.Treatment with Sorafenib Sandoz may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, blood thinners to prevent blood clots, there may be an increased risk of bleeding.
• If you experience chest pain or heart problems, your doctor may decide to temporarily stop treatment with Sorafenib Sandoz or stop it altogether.
• If you experience heart problems, such as abnormal electrical activity, called "QT interval prolongation".
• If you are scheduled for surgery or have recently undergone surgery. Sorafenib Sandoz may affect wound healing. Sorafenib Sandoz is usually stopped in case of surgery. Your doctor will decide when to resume treatment with Sorafenib Sandoz.
• If you are taking irinotecan or receiving docetaxel, which are also cancer medicines. Sorafenib Sandoz may enhance their effect, especially their side effects.
• If you are taking neomycin or other antibiotics,the effectiveness of Sorafenib Sandoz may be reduced.
• If you have severe liver dysfunction,more serious side effects may occur during treatment.
• If you have kidney dysfunction, your doctor will monitor your fluid and electrolyte balance.
• Fertility.Sorafenib Sandoz may reduce fertility in both men and women. Any questions about fertility should be discussed with your doctor.
• Gastrointestinal perforationmay occur during treatment (see section 4: Possible Side Effects). In this case, your doctor will advise you to stop treatment.

If any of these situations apply to you, you should inform your doctor. It may be necessary to treat or your doctor may decide to change the dose of Sorafenib Sandoz or stop treatment altogether (see also section 4: Possible Side Effects)

Children and Adolescents

So far, no studies have been conducted on the use of Sorafenib Sandoz in children and adolescents.

Sorafenib Sandoz and Other Medicines

Some medicines may affect the action of Sorafenib Sandoz, or their action may be changed by Sorafenib Sandoz. You should tell your doctor or pharmacist about any of the following medicines that you are taking or have recently taken, as well as any medicines that you plan to take and any other medicines, including those available without a prescription:

• Rifampicin, neomycin or other medicines used to treat infections (antibiotics)
• St. John's Wort, used to treat depression
• Phenytoin, carbamazepine or phenobarbital, medicines used in epilepsyand other diseases
• Dexamethasone, corticosteroidgiven in various diseases
• Warfarin or phenprocoumon, anticoagulant medicines given to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan - cancer medicines
• Digoxin, used to treat mild and moderate heart failure

Pregnancy and Breast-Feeding

You should avoid becoming pregnant while taking Sorafenib Sandoz.If there is a risk that you may become pregnant while taking Sorafenib Sandoz, you should use effective contraception during treatment. If you become pregnant while taking Sorafenib Sandoz, you should inform your doctor immediately, who will decide whether treatment can be continued.
You should not breast-feed while taking Sorafenib Sandoz,as this medicine may affect the growth and development of your child.

Driving and Using Machines

There is no data on the effect of Sorafenib Sandoz on the ability to drive and use machines.

Sorafenib Sandoz Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to Take Sorafenib Sandoz

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended Dose of Sorafenib Sandoz for Adults is 400 mg, Twice a Day.

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 meals with low or moderate fat content. You should not take the medicine with high-fat meals, as this may reduce the effectiveness of Sorafenib Sandoz. If you plan to have a high-fat meal, you should take the tablets at least 1 hour before or 2 hours after the meal.
This medicine should always be taken exactly as your doctor has told you. If you are not sure, 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 blood.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
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 Sandoz Than Recommended

You should immediately inform your doctorif you (or anyone else) have taken a dose higher than recommended. Taking too much Sorafenib Sandoz may increase the risk of side effects or make them worse, especially diarrhea and skin reactions. Your doctor may advise you to stop treatment.

Missing a Dose of Sorafenib Sandoz

If you miss a dose, you should take it as soon as you remember. If the time for the next dose is near, you should skip the missed dose and continue treatment as before. You should not take a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medicines, this medicine 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, headache, bone pain, 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, bleeding 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 affect up to 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness in the mouth, pain in the tongue (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)
• disorders of sensation in the 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 and 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 white blood cell count (leukopenia and neutropenia)
• reduced red blood cell count (anemia)
• low platelet count (thrombocytopenia)
• inflammation of the hair follicles
• reduced thyroid function (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste disorders
• 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
• 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 bile pigments (hyperbilirubinemia)
• allergic reactions (including skin reactions and hay fever)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (lung disease)
• eczema
• increased thyroid function (hyperthyroidism)
• multiple skin eruptions (erythema multiforme)
• abnormally high blood pressure
• perforation of the gastrointestinal tract (gastrointestinal perforation)
• reversible posterior leukoencephalopathy syndrome, which may be associated with headache, disturbances of consciousness, seizures, and visual disturbances, including loss of vision (reversible posterior leukoencephalopathy syndrome)
• sudden, severe allergic reaction (anaphylactic reaction)

Rare:

May affect up to 1 in 1000 people

• allergic reaction with skin swelling (e.g. face, tongue), which can cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (QT interval prolongation)
• inflammation of the liver, which can cause nausea, vomiting, abdominal pain, and jaundice (drug-induced hepatitis)
• sunburn-like rash, which can occur on skin previously exposed to radiation, and its severity can be severe (radiation-induced dermatitis)
• severe skin and (or) mucous membrane reactions, which can include painful blisters and fever, including widespread skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal breakdown of muscle tissue, which can lead to kidney dysfunction (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:
Frequency cannot be estimated from the available data

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

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system: Department of Medicines Monitoring, 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
You can also report side effects 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 Sandoz

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 Package and Other Information

What Sorafenib Sandoz Contains

• The active substance is sorafenib. Each film-coated tablet contains 400 mg of sorafenib (as sorafenib tosylate).
• The other ingredients are: hypromellose 2910, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350.

What Sorafenib Sandoz Looks Like and Contents of the Package

White or almost white, oval, film-coated tablets with a score line on one side and smooth on the other, 20.1 mm x 10.1 mm ± 5%.
The medicine is available in blisters of aluminum/OPA/aluminum/PVC containing 56 film-coated tablets and in perforated unit dose blisters of aluminum/OPA/aluminum/PVC containing 56 x 1 tablet.

Marketing Authorization 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 Further Information on This Medicine, Please Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands
Sorafenib Sandoz 400 mg, film-coated tablets
Austria
Sorafenib Sandoz 400 mg - film-coated tablets
Belgium
Sorafenib Sandoz 400 mg film-coated tablets
Czech Republic
Sorafenib Sandoz
Germany
Sorafenib HEXAL 400 mg film-coated tablets
Denmark
Sorafenib Sandoz
Estonia
Sorafenib Sandoz
Greece
Sorafenib/Sandoz film-coated tablets
Spain
Sorafenib Sandoz 400 mg film-coated tablets EFG
Croatia
Sorafenib Sandoz 400 mg film-coated tablets
Hungary
Sorafenib Sandoz 400 mg film-coated tablet
Lithuania
Sorafenib Sandoz 400 mg film-coated tablets
Latvia
Sorafenib Sandoz 400 mg film-coated tablets
Poland
Sorafenib Sandoz
Portugal
Sorafenib Sandoz
Romania
Sorafenib Sandoz 400 mg film-coated tablets
Slovakia
Sorafenib Sandoz 400 mg
Date of Last Revision of the Leaflet:05/2022
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