Sorafenib G.l.

Leaflet included in the packaging: patient information

Sorafenib G.L., 200 mg, film-coated tablets
Sorafenibum
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leafletso that you can read it again if you need to.
• If you have any further questions, you should 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sorafenib G.L. and what is it used for
• 2. Important information before taking Sorafenib G.L.
• 3. How to take Sorafenib G.L.
• 4. Possible side effects
• 5. How to store Sorafenib G.L.
• 6. Contents of the pack and other information

1. What is Sorafenib G.L. and what is it used for

Sorafenib G.L. is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib G.L. is also used to treat kidney cancer in advanced stages (advanced renal cell carcinoma) in patients for whom standard therapy has not worked or is not considered appropriate.
Sorafenib G.L. is a so-called multikinase inhibitor. It works by reducing the rate of growth of cancer cells and cutting off the blood supply that supports the growth of cancer cells.

2. Important information before taking Sorafenib G.L.

When not to take Sorafenib G.L.

• 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 G.L., you should discuss it with your doctor or pharmacist.

When to be particularly careful when taking Sorafenib G.L.

• If skin changes occur. Sorafenib G.L. may cause rash and skin reactions, especially on the palms of the hands and soles of the feet. These changes can usually be treated by the attending physician. If they do not disappear, the doctor may temporarily discontinue treatment with Sorafenib G.L. or stop it completely.
• If the person prescribed the medicine has high blood pressure. Sorafenib G.L. may increase blood pressure. The attending physician will check blood pressure and may prescribe medications to lower it if necessary.
• If the patient has or has had an aneurysm(enlargement and weakening of the wall of a blood vessel) or rupture of a blood vessel.
• If the person prescribed the medicine has diabetes. In diabetic patients, blood sugar levels should be regularly checked to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of hypoglycemia.
• If bleeding occursor if the person prescribed Sorafenib G.L. takes warfarin or phenprocoumon. Treatment with Sorafenib G.L. may increase the risk of bleeding. A person 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 doctor may consider it necessary to discontinue treatment with Sorafenib G.L. or stop it completely.
• If heart problems occur, such as abnormal heart rhythm, known as "QT interval prolongation".
• If surgery is planned or has recently been performed. Sorafenib G.L. may affect wound healing. Usually, Sorafenib G.L. is discontinued in the event of surgery. The attending physician will decide when to resume treatment with Sorafenib G.L.
• If the person prescribed Sorafenib G.L. is also taking irinotecan or receiving docetaxel, which are also anticancer medicines. Sorafenib G.L. may enhance their effect, especially adverse reactions.
• If neomycin or other antibiotics are taken, the effectiveness of Sorafenib G.L. may be reduced.
• If severe liver dysfunction occurs, more serious side effects may occur during treatment.
• In case of impaired renal function, the doctor will monitor fluid and electrolyte balance.
• Fertility. Sorafenib G.L. may reduce fertility in both men and women. Any issues related to fertility should be discussed with the doctor.
• Gastrointestinal perforation. During treatment, a rupture of the gastrointestinal tract (see also section 4: Possible side effects) may occur. In this case, the doctor will recommend discontinuing treatment.
• If the patient experiences the following symptoms, they should contact their doctor immediately, as it may be a life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, decreased urine output, and fatigue. Such symptoms may be caused by a group of metabolic complications that may occur during cancer treatment, caused by the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may lead to kidney dysfunction and acute kidney failure (see also section 4. Possible side effects).

You should inform your doctor if any of the above circumstances apply to

the person prescribed Sorafenib G.L.In these cases, appropriate treatment may be necessary, and the doctor may decide to change the dose of Sorafenib G.L. or discontinue it completely (see also section 4: Possible side effects).

Children and adolescents

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

Sorafenib G.L. and other medicines

Some medicines may affect the action of Sorafenib G.L. or their action may be changed by Sorafenib G.L. You should tell your doctor or pharmacist about any of the following medicines and any other medicines you are currently taking 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 phenprocoumon, 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

You should avoid becoming pregnant while taking Sorafenib G.L.If there is a possibility that you may become pregnant, you should use effective contraception during treatment. If you become pregnant during therapy, you should contact your doctor immediately, who will decide whether to continue treatment.
You should not breastfeed while taking Sorafenib G.L., as sorafenib may affect the growth and development of the child.

Driving and using machines

There is no data indicating that Sorafenib G.L. may impair the ability to drive and use machines.

Sorafenib G.L. contains sodium

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

3. How to take Sorafenib G.L.

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

Recommended dose of Sorafenib G.L. for adults is two times a day, two tablets of 200 mg each.

This corresponds to a daily dose of 800 mg or four tablets.
Sorafenib G.L. should be swallowed, with a glass of water, on an empty stomach or with meals of low or moderate fat content. You should not take the medicine with high-fat meals, as this may reduce the effectiveness of Sorafenib G.L. If you plan to eat 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 prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
It is important to take this medicine at the same time every day to ensure a constant amount of the medicine in the blood.
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 G.L. than recommended

You should immediately inform your doctorif you (or anyone else) have taken a dose of Sorafenib G.L. that is higher than recommended. Taking too much Sorafenib G.L. may increase the risk of side effects or make them more severe, especially diarrhea and skin reactions. The doctor may recommend discontinuing treatment with this medicine.

Missing a dose of Sorafenib G.L.

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 the 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 up to 1 in 10 people

• diarrhea
• nausea (nausea)
• feeling weak or tired (fatigue)
• pain (including pain in the mouth, abdominal pain, bone pain, headache, cancer pain)
• hair loss (alopecia)
• redness or pain on the palms of the hands or soles of the feet (hand-foot syndrome)
• rash or itching
• 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 of the mouth, tongue pain (oral mucositis and mucosal inflammation)
• 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)
• hiccups
• skin characteristics, dry and flaky skin (dermatitis, desquamation)
• heart failure
• heart attack (myocardial infarction)or chest pain
• ringing in the ears (tinnitus)
• kidney failure
• excessively 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 (folliculitis)
• reduced thyroid activity (hypothyroidism)
• low sodium levels in the blood (hyponatremia)
• taste disorders (dysgeusia)
• redness of the face and often other skin areas (flushing)
• runny nose (rhinitis)
• heartburn (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma/skin cancer)
• 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 mucous membrane (mucositis)of the stomach
• abdominal pain caused by inflammation of the pancreas, inflammation of the gallbladder, and (or) bile ducts
• jaundice or yellowing of the skin and 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 (eczema)
• increased thyroid activity (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• exceptionally high blood pressure
• perforation of the gastrointestinal tract (gastrointestinal perforation)
• reversible posterior brain edema, 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)

• nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, decreased urine output, and fatigue [tumor lysis syndrome (TLS)] (see section 2).
• brain function 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 rupture of a blood vessel (aneurysms and arterial dissection).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Sorafenib G.L.

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry datestated on the packaging and blister after: EXP. The expiry date refers to the last day of the month stated.
Do not store this medicine at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sorafenib G.L. contains

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

What Sorafenib G.L. looks like and what the pack contains

Sorafenib G.L. is a red-brown, round, biconvex film-coated tablet with "200" embossed on one side and smooth on the other, with a diameter of 12.0 mm ± 5%.
A perforated single-dose aluminum/PVC/PE/PVDC blister in a cardboard box contains 112 film-coated tablets.
An aluminum/PVC/PE/PVDC blister in a cardboard box contains 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Remedica Ltd

Aharnon Street,
Limassol Industrial Estate,
3056 Limassol,
Cyprus
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
BBG3000 Birzebbugia
Malta

To obtain more detailed information and information on the names of the medicinal product in other EEA countries, you should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 12.10.2022