Sorafenib pharmascience

Patient Information Leaflet

Sorafenib Pharmascience, 200 mg, coated tablets
Sorafenibum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, 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 Pharmascience is and what it is used for
2. Important information before taking 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 in the treatment of liver cancer (hepatocellular carcinoma).
Sorafenib Pharmascience is also used in the treatment of advanced kidney cancer
(advanced renal cell carcinoma) in patients in whom standard therapy has not resulted in disease control or is considered inappropriate.
Sorafenib Pharmascience is a so-called multi-kinase inhibitor. It works by slowing down the growth of cancer cells and by cutting off the blood supply that supports the growth of cancer cells.

2. Important information before taking Sorafenib Pharmascience

When not to take Sorafenib Pharmascience

• 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 Pharmascience, discuss this with your doctor or
pharmacist.
When to exercise special caution when using Sorafenib Pharmascience

• If skin changes occur. Sorafenib Pharmascience may cause rash and skin reactions, especially on the palms of the hands and soles of the feet. Usually, these changes can be managed by the treating physician. If they do not resolve, your doctor may temporarily interrupt treatment with Sorafenib Pharmascience or discontinue it completely.
• If the person prescribed the medicine has high blood pressure. Sorafenib Pharmascience may increase blood pressure. Your treating doctor will monitor your blood pressure values and may prescribe medications to lower it if necessary.
• If the patient has or has previously had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
• If the person prescribed the medicine has diabetes. Blood glucose levels should be monitored regularly in diabetic patients to assess whether the dose of antidiabetic medication needs adjustment to minimize the risk of low blood sugar levels.
• If any bleeding occurs, or if the patient is taking warfarin or phenprocoumon. Treatment with Sorafenib Pharmascience may increase the risk of bleeding. Patients 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 decide to interrupt or completely discontinue treatment with Sorafenib Pharmascience.
• If the patient has heart disorders, such as abnormal electrical activity known as "QT interval prolongation".
• If the patient is planning a surgical procedure or has recently undergone surgery. Sorafenib Pharmascience may affect wound healing. Usually, the use of Sorafenib Pharmascience is withheld during surgical procedures. Your treating doctor will decide when to resume treatment.
• If the patient prescribed Sorafenib Pharmascience is also taking irinotecan or receiving docetaxel, which are also anticancer drugs. Sorafenib Pharmascience may enhance their effects, particularly their adverse reactions.
• If the patient is taking neomycin or other antibiotics, the effectiveness of Sorafenib Pharmascience may be reduced.
• If the patient has severe liver function impairment, more severe adverse reactions may occur during treatment.
• If the patient has impaired kidney function, the doctor will monitor fluid and electrolyte balance.
• Fertility. Sorafenib Pharmascience may reduce fertility in both men and women. Discuss any fertility-related concerns with your doctor.
• Gastrointestinal perforation. A break in the wall of the gastrointestinal tract may occur during treatment (see also section 4: Possible side effects). In such a case, the doctor will recommend discontinuation of sorafenib treatment.
• If the patient experiences any of the following symptoms, contact a 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 kidney dysfunction and acute kidney failure (see also section 4: Possible side effects).

You should inform your doctor if any of the above situations apply to the patient
prescribed Sorafenib Pharmascience. Appropriate treatment may then be required, or the doctor may decide to adjust the dose of Sorafenib
Pharmascience or discontinue its use completely (see also section 4: Possible side effects).
Children and adolescents
Studies on the use of Sorafenib Pharmascience in children and adolescents have not yet been conducted.
Sorafenib Pharmascience and other medicines
Some medicines may affect the action of Sorafenib Pharmascience, or their effects may be altered by Sorafenib Pharmascience. Inform your doctor or pharmacist about any of the medicines listed below and any other medicines currently or recently taken, or those 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 diseases
• Warfarin or phenprocoumon, anticoagulant medicines used to prevent thrombosis
• 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 Pharmascience. If there is a possibility that the patient could become pregnant, an effective method of contraception should be used during treatment. If pregnancy occurs during therapy, the patient should contact the doctor immediately, who will decide whether treatment can be continued.
Breastfeeding must not be undertaken during treatment with Sorafenib Pharmascience, as sorafenib may affect the child's growth and development.
Driving and operating machinery
There are no data indicating that Sorafenib Pharmascience impairs the ability to drive or operate machinery.
Sorafenib Pharmascience contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is essentially "sodium-free."

3. How to take Sorafenib Pharmascience

The recommended dose of Sorafenib Pharmascience in adults is two tablets of 200 mg sorafenib taken 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 a meal low or moderate in fat. Do not take the medicine with high-fat meals, as this may reduce the effectiveness of Sorafenib Pharmascience. If a patient intends to consume a high-fat meal, 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 the physician. In case of doubt, consult a doctor or pharmacist.
It is important to take this medicine at approximately the same time each day to ensure a consistent level of the drug in the bloodstream.
This medicine is usually administered for as long as it provides clinical benefit and as long as the patient does not experience unacceptable side effects.
Taking more Sorafenib Pharmascience than prescribed
Contact your doctor immediately if the person prescribed Sorafenib Pharmascience (or anyone else) has taken more than the prescribed dose. Taking Sorafenib Pharmascience in excess may increase the risk or severity of adverse effects, particularly diarrhea and skin reactions. The doctor may advise discontinuation of treatment with this medicine.
Missing a dose of Sorafenib Pharmascience
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 continued as originally scheduled. 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 experiences them.
This medicine may also affect the results of certain blood tests.

Very common:
May occur in more than 1 in 10 people

• diarrhoea
• nausea (nausea)
• feeling weak or tired (fatigue)
• pain (including mouth pain, abdominal pain, bone pain, headache, tumour-related pain)
• hair loss (alopecia)
• redness or pain in the palms of the hands or soles of the 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

Common:
May occur in no more than 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness in the mouth, tongue pain (inflammation of the mouth and mucous membranes)
• 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
• inflammatory skin conditions, dry and flaky skin (dermatitis, skin desquamation)
• heart failure
• heart attack (myocardial infarction) or chest pain
• ringing in the ears (tinnitus)
• kidney failure
• exceptionally high protein levels in urine (proteinuria)
• general weakness or loss of strength (asthenia)
• reduced number of white blood cells (leukopenia and neutropenia)
• reduced number of red blood cells (anaemia)
• low platelet count (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• reduced thyroid activity (hypothyroidism)
• low sodium levels in the blood (hyponatraemia)
• taste disturbances (dysgeusia)
• redness of the face and often other skin areas (flushing)
• watery nasal discharge (watery rhinitis)
• heartburn (gastroesophageal reflux disease)
• skin cancer (squamous cell carcinoma or cutaneous squamous cell carcinoma)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle cramps (muscle cramps)

Uncommon:
May occur in no more than 1 in 100 people

• inflammation of the mucous membrane (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)
• various skin eruptions (erythema multiforme)
• exceptionally 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 syndrome)
• sudden, severe allergic reaction (anaphylactic reaction)

Rare:
May occur in no more than 1 in 1000 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 radiotherapy, and may be severe (radiation-induced skin reaction)
• severe skin and/or mucous membrane reactions, including painful blisters and fever, and 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 (leukocytoclastic vasculitis)

Unknown (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 the 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 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 Pharmascience

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry
date (EXP), and on each blister after: EXP. The expiry date refers to the last day of the stated
month.
Aluminium/OPA/Aluminium/PVC blisters:
No special storage conditions required for this medicinal product.
Aluminium/PVC/PE/PVDC blisters:
Do not store this medicine 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sorafenib Pharmascience contains

• The active substance is sorafenib. Each coated tablet contains 200 mg of sorafenib (as tosylate).
• Other ingredients are: tablet core: hypromellose 2910 (E464), sodium croscarmellose (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514).
  Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), iron oxide, red (E172).

What Sorafenib Pharmascience looks like and contents of the pack
Sorafenib Pharmascience coated tablets are red-brown, round, biconvex, with the engraved mark "200" on one side and smooth on the other side, with a diameter of 12.0 mm ± 5%.

Packaged in:
Aluminum/PVC/PE/PVDC foil blisters containing 28, 56, or 112 coated tablets, printed with abbreviations of the days of the week, in a cardboard box.
Perforated single-dose aluminum/PVC/PE/PVDC foil blisters containing 56 or 112 coated tablets, printed with abbreviations of the days of the week, in a cardboard box.
Aluminum/OPA/Aluminum/PVC foil blisters containing 60 coated tablets, printed with abbreviations of the days of the week, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the EEA Member States under the following names: