Sorafenib Pharmascience

Package Leaflet: Information for the User

Sorafenib Pharmascience,200 mg, film-coated tablets
Sorafenibum

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 pack and other information

• 1. What Sorafenib Pharmascience is and what it is used for
• 2. Before you take Sorafenib Pharmascience
• 3. How to take Sorafenib Pharmascience
• 4. Possible side effects
• 5. How to store Sorafenib Pharmascience
• 6. Contents of the pack and other information

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

Sorafenib Pharmascience is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Pharmascience 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 Pharmascience 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. Before you take Sorafenib Pharmascience

When you should not take Sorafenib Pharmascience

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

Warnings and precautions

Before taking Sorafenib Pharmascience, discuss this with your doctor or pharmacist.

When to be extra careful while taking Sorafenib Pharmascience

• If you have skin changes. Sorafenib Pharmascience 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 your treatment with Sorafenib Pharmascience or stop it altogether.
• If you have high blood pressure. Sorafenib Pharmascience may increase your blood pressure. Your doctor will check your blood pressure and may give you medicine to lower it if necessary.
• 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. You should regularly check your blood sugar levels to see if your diabetes medication needs to be adjusted to minimize the risk of low blood sugar.
• If you experience any bleeding, or if you are taking warfarin or phenprocoumon. Treatment with Sorafenib Pharmascience may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, which reduce blood clotting to prevent clots, you may have an increased risk of bleeding.
• If you experience chest pain or heart problems, your doctor may decide to stop your treatment with Sorafenib Pharmascience or stop it altogether.
• If you have heart problems, such as abnormal heart rhythm, known as "QT interval prolongation".
• If you are going to have surgery or have recently had an operation. Sorafenib Pharmascience may affect wound healing. It is usually stopped before surgery. Your doctor will decide when to resume treatment with Sorafenib Pharmascience.
• If you are taking irinotecan or receiving docetaxel, which are also cancer medicines. Sorafenib Pharmascience may increase their effects, especially side effects.
• If you are taking neomycin or other antibiotics, the effectiveness of Sorafenib Pharmascience may be reduced.
• If you have severe liver problems, you may experience more serious side effects while taking this medicine.
• If you have kidney problems, your doctor will monitor your fluid and electrolyte balance.
• Fertility. Sorafenib Pharmascience may reduce fertility in both men and women. Any questions about fertility should be discussed with your doctor.
• Perforation of the digestive tract. During treatment, a hole in the wall of the digestive tract (see also section 4: Possible side effects) may occur. In this case, your doctor will advise you to stop treatment with sorafenib.
• 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 cramps, 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 problems and acute kidney failure (see also section 4. Possible side effects).

Tell your doctor if any of the above applies to you

before taking Sorafenib Pharmascience. You may need to receive appropriate treatment, or your doctor may decide to change the dose of Sorafenib Pharmascience or stop it altogether (see also section 4: Possible side effects).

Children and adolescents

No studies have been conducted on the use of Sorafenib Pharmascience in children and adolescents.

Sorafenib Pharmascience and other medicines

Some medicines may affect the way Sorafenib Pharmascience works, or their effect may be altered by Sorafenib Pharmascience. Tell your doctor or pharmacist about any of the following medicines and any other medicines you are taking, or have recently taken, including those obtained 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, used to treat epilepsyand other conditions
• Dexamethasone, a corticosteroidused in various diseases
• Warfarin or phenprocoumon, anticoagulant medicines used to prevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - cancer medicines
• Digoxin, used to treat mild and moderate heart failure.

Pregnancy and breastfeeding

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

Driving and using machines

There is no evidence to suggest that Sorafenib Pharmascience may affect your ability to drive or operate machines.

Sorafenib Pharmascience contains sodium

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

3. How to take Sorafenib Pharmascience

The recommended dose of Sorafenib Pharmascience for adults is two 200 mg tablets twice daily.

This corresponds to a daily dose of 800 mg or four tablets.
Sorafenib Pharmascience tablets should be swallowed with a glass of water, on an empty stomach or with meals with low or moderate fat content. Do not take this medicine with high-fat meals, as it may reduce the effectiveness of Sorafenib Pharmascience. If you plan to eat a high-fat meal, 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, 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 your bloodstream.
This medicine is usually taken for as long as it provides clinical benefits and as long as you do not experience unacceptable side effects.

If you take more Sorafenib Pharmascience than you should

Tell your doctor immediatelyif you (or someone else) have taken more Sorafenib Pharmascience than prescribed. Taking too much Sorafenib Pharmascience may increase the risk of side effects or make them worse, especially diarrhea and skin reactions. Your doctor may advise you to stop treatment with this medicine.

If you forget to take Sorafenib Pharmascience

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Sorafenib Pharmascience 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, bone pain, headache, cancer 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 bleeding in the brain, from the intestinal wall, 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 (stomatitis and mucositis)
• low calcium levels in the blood (hypocalcemia)
• low potassium levels in the blood (hypokalemia)
• low blood sugar (hypoglycemia)
• muscle pain (myalgia)
• sensory disturbances 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, desquamation)
• heart failure
• heart attack (myocardial infarction)or chest pain
• ringing in the ears (tinnitus)
• kidney failure
• very 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 function ( hypothyroidism)
• low sodium levels in the blood ( hyponatremia)
• taste disturbances (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinitis)
• heartburn ( gastroesophageal reflux disease)
• skin cancer ( squamous cell carcinoma or basal cell carcinoma of the skin)
• 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 ( gastritis)
• abdominal pain caused by inflammation of the pancreas, inflammation of the 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 rashes (erythema multiforme)
• very high blood pressure
• perforation of the digestive tract (perforation of the gastrointestinal tract)
• reversible brain disorder, 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).

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 liver injury)
• skin rash like sunburn, which can occur on skin previously exposed to radiation, and can be severe (radiation-induced dermatitis)
• severe skin and (or) mucous membrane reactions, including 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 problems (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).

Unknown(frequency cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety 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.
Side effects can also be reported 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 Pharmascience

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry datestated on the carton after EXP, and on each blister after EXP. The expiry date refers to the last day of the month stated.
Aluminium/OPA/Aluminium/PVC blisters:
No special storage precautions are required for this medicinal product.
Aluminium/PVC/PE/PVDC blisters:
Do not store this medicine at temperatures above 30°C.
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 pack and other information

What Sorafenib Pharmascience contains

• The active substanceis sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• Otheringredients are: tablet core: hypromellose 2910 (E464), croscarmellose sodium (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514). tablet coating: hypromellose 2910 (E464), titanium dioxide (E 171), macrogol (E1521), iron oxide, red (E 172).

What Sorafenib Pharmascience looks like and contents of the pack

Sorafenib Pharmascience film-coated tablets are reddish-brown, round, biconvex with the inscription "200" on one side and smooth on the other, with a diameter of 12.0 mm ± 5%.
Packaged in:
Aluminium/PVC/PE/PVDC blisters containing 28, 56, or 112 film-coated tablets with the abbreviations of the days of the week printed on them, in a cardboard box.
Aluminium/PVC/PE/PVDC blisters, single-dose, containing 56 or 112 film-coated tablets with the abbreviations of the days of the week printed on them, in a cardboard box.
Aluminium/OPA/Aluminium/PVC blisters containing 60 film-coated tablets with the abbreviations of the days of the week printed on them, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmascience International Ltd.
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer

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

This medicinal product is authorized in the Member States of the EEA under the following names:

Date of last revision of the leaflet:05/2022