Patient Information Leaflet

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

Keep this leaflet, as you may need to read it again.
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. 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.

Table of Contents

What Sorafenib Mylan is and what it is used for
Important information before taking Sorafenib Mylan
How to take Sorafenib Mylan
Possible side effects
How to store Sorafenib Mylan
Contents of the pack and other information

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

Sorafenib Mylan is used in the treatment of liver cancer (hepatocellular carcinoma).
Sorafenib Mylan is also used in the treatment of advanced kidney cancer (advanced renal cell carcinoma) in patients in whom standard therapy has not been effective in halting disease progression or is considered unsuitable.
Sorafenib Mylan 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 Mylan

When not to take Sorafenib Mylan

if the patient has a hypersensitivity to sorafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Sorafenib Mylan, discuss this with your doctor or
pharmacist.
When to exercise special caution when taking Sorafenib Mylan

If skin changes occur. Sorafenib Mylan may cause rash and skin reactions, particularly 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 Mylan or discontinue it completely.
If the patient has high blood pressure. Sorafenib Mylan may increase blood pressure. The treating doctor will
monitor blood pressure values and, if elevated, may prescribe medications to
lower them.
If the patient has or has had an aneurysm (a weakened and dilated blood vessel wall) or a ruptured blood vessel.
If the patient has diabetes. Blood glucose levels should be monitored regularly in diabetic patients to determine whether the dose of antidiabetic medication needs adjustment to minimize the risk of hypoglycemia.
If any bleeding occurs or if the patient is taking warfarin or phenprocoumon. Treatment with Sorafenib Mylan 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 discontinue treatment with Sorafenib Mylan.
If cardiac disorders occur, such as electrical abnormalities known as "QT interval prolongation."
If surgery is planned or has recently been performed. Sorafenib Mylan may affect wound healing. Usually, Sorafenib Mylan is discontinued before surgery. The treating doctor will decide when to resume treatment.
If the patient is also taking irinotecan or receiving docetaxel, which are also anticancer medicines. Sorafenib Mylan may enhance their effects, particularly adverse reactions.
If neomycin or other antibiotics are being taken. The effectiveness of Sorafenib Mylan may be reduced.
If severe liver dysfunction occurs, more serious adverse reactions may occur during treatment.
In case of impaired kidney function. The doctor will monitor fluid and electrolyte balance.
Fertility. Sorafenib Mylan may impair fertility in both men and women. Any fertility-related concerns should be discussed with the doctor.
Gastrointestinal perforation. During treatment, a break in the continuity of the gastrointestinal tract wall may occur (see also section 4: Possible side effects). In such a case, the doctor will recommend discontinuation of 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).

Inform your doctor if any of the above conditions apply to the patient. In such cases, appropriate treatment may be required; the doctor may decide to adjust the dose of Sorafenib Mylan or discontinue treatment completely (see also section 4: Possible side effects).
Children and adolescents
Studies on the use of Sorafenib Mylan in children and adolescents have not yet been conducted.
Sorafenib Mylan and other medicines
Some medicines may affect the action of Sorafenib Mylan, or their action may be altered by Sorafenib Mylan. Inform your doctor or pharmacist about any of the medicines listed below and any other medicines currently or recently taken, or those planned for use, 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, anticoagulants 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 Mylan. 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 continue.
Breastfeeding is not recommended during treatment with Sorafenib Mylan, as sorafenib may affect the growth and development of the child.
Driving and using machines
There are no data indicating that Sorafenib Mylan may impair the ability to drive or operate machinery.
Sorafenib Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Sorafenib Mylan

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The recommended dose of Sorafenib Mylan for adults is two tablets twice daily, each
tablet containing 200 mg.
This corresponds to a daily dose of 800 mg or four tablets.
Sorafenib Mylan 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 Mylan. If planning to eat 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 directed by a doctor. If in 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 medicine in the bloodstream.
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 Mylan than recommended
Immediately inform the doctor if the person prescribed Sorafenib Mylan (or anyone
else) has taken more than the recommended dose. Taking too much Sorafenib Mylan
may increase the risk of side effects or make them more severe, especially diarrhea and
skin reactions. The doctor may advise stopping treatment with this medicine.
Missing a dose of Sorafenib Mylan
If a patient misses a dose, they should take it as soon as they remember. If it is almost time
for the next dose, the missed dose should be skipped and the regular dosing schedule
should be continued. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. This medicine may also affect the results of certain blood tests.

Very common:
May affect 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 hands or 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 affect no more than 1 in 10 people

flu-like symptoms
indigestion (dyspepsia)
difficulty swallowing (dysphagia)
inflammation or dryness in the mouth, tongue pain (oral mucositis and mucosal inflammation)
low calcium levels in blood (hypocalcaemia)
low potassium levels in 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, 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)
inflammation of hair follicles (folliculitis)
reduced thyroid activity (hypothyroidism)
low sodium levels in 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/skin squamous cell carcinoma)
thickening of the outer layer of skin (hyperkeratosis)
sudden, involuntary muscle cramps (muscle cramps)

Uncommon:
May affect no more than 1 in 100 people

inflammation of the (lining) mucous membrane of the stomach
abdominal pain caused by pancreatitis, inflammation of the gallbladder and (or) bile ducts
yellowing of the skin or eyes (jaundice) caused by 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)
extremely 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 affect 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)
hepatitis, 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 become severe (radiation-induced dermatitis)
severe skin and (or) mucosal reactions, including 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)

Unknown:
Frequency cannot be estimated from available data

disturbances in brain function, which may include drowsiness, changes in behaviour or disorientation (encephalopathy)
dilation and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysms 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sorafenib Mylan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister
after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should not be disposed of via the sewage system 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 Mylan contains

The active substance is sorafenib. Each 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, red iron oxide (E172).

What Sorafenib Mylan looks like and contents of the pack
Sorafenib Mylan 200 mg coated tablets are red-brown, round, biconvex coated tablets,
embossed with the number "200" on one side and plain on the other, with a diameter of 12.0 mm ± 5%.
They are packed in cartons containing 112 coated tablets in blisters made of Aluminium/PVC/PE/PVDC film, with printed abbreviations of the days of the week.
They are also packed in cartons containing 112 x 1 coated tablets in perforated single-dose blisters made of Aluminium/PVC/PE/PVDC film, with printed abbreviations of the days of the week.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
13 Dublin
Ireland

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

For more detailed information about the medicine and its names in the countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400