Sorafenib Milan

Leaflet attached to the packaging: patient information

Sorafenib Mylan, 200 mg, film-coated tablets

Sorafenib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Sorafenib Mylan is used to treat liver cancer (hepatocellular carcinoma).
Sorafenib Mylan is also used to treat advanced kidney cancer (advanced renal cell carcinoma)in patients who have not responded to standard therapy or for whom it is not indicated.
Sorafenib Mylan is a so-called multikinase inhibitor.It works by reducing the growth rate of cancer cells and 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 is allergicto sorafenib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Sorafenib Mylan, discuss it 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, especially on the hands and feet. These changes can usually be treated by the attending physician. If they do not resolve, the doctor may temporarily discontinue treatment with Sorafenib Mylan or stop it altogether.
• If the person prescribed the medicine has high blood pressure. Sorafenib Mylan may increase blood pressure. The attending physician will monitor blood pressure and may prescribe medications to lower it if necessary.

if the person prescribed the medicine has or has had an aneurysm(enlargement and weakening of the blood vessel wall) or has had a blood vessel rupture.

• 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 the medicine is taking warfarin or phenprocoumon.Treatment with Sorafenib Mylan 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 Mylan or stop it altogether.
• If heart rhythm disorders occur, such as abnormal electrical activity, called "QT interval prolongation".
• If surgery is planned or has recently been performed. Sorafenib Mylan may affect wound healing. Sorafenib Mylan is usually discontinued in the event of surgery. The attending physician will decide when to resume treatment with Sorafenib Mylan.
• If the person prescribed the medicine is also taking irinotecan or receiving docetaxel,which are also anticancer medicines. Sorafenib Mylan may enhance their effect, especially adverse reactions.
• If neomycin or other antibiotics are taken.The effectiveness of Sorafenib Mylan may be reduced.
• If severe liver dysfunction occurs, more serious adverse reactions may occur during treatment with Sorafenib Mylan.
• In the event of impaired kidney function. The doctor will monitor fluid and electrolyte balance.
• Fertility.Sorafenib Mylan may reduce fertility in both men and women. Any fertility issues should be discussed with the doctor.
• Gastrointestinal perforation.During treatment, a rupture of the gastrointestinal wall may occur (see also section 4: Possible side effects). In this case, the doctor will recommend discontinuing treatment.
• If the patient experiences any of 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, cloudy urine, 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).

The doctor should be informed if any of the above circumstances

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

Children and adolescents

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

Sorafenib Mylan and other medicines

Some medicines may affect the action of Sorafenib Mylan or have their action changed by Sorafenib Mylan. The doctor or pharmacist should be informed about any medicines from the following list and any other medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, 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, corticosteroidadministered in various diseases
• Warfarin or phenprocoumon, anticoagulant medicines administered to prevent thrombosis
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan - anticancer medicines
• Digoxin, used to treat mild and moderate heart failure

Pregnancy and breastfeeding

Pregnancy should be avoided during treatment with Sorafenib Mylan. If there is a possibility that the patient may become pregnant, they should use effective contraception during treatment. If the patient becomes pregnant during therapy, they should contact their doctor immediately, who will decide whether to continue treatment.
Breastfeeding should not be done during treatment with Sorafenib Mylan, as sorafenib may affect the growth and development of the child.

Driving and operating machinery

There is no data indicating that Sorafenib Mylan may impair the ability to drive vehicles and operate machinery.

Sorafenib Mylan contains sodium

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

3. How to take Sorafenib Mylan

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, consult the doctor or pharmacist.

Recommended dose of Sorafenib Mylan for adults is two 200 mg tablets twice daily.

This corresponds to a daily dose of 800 mg or four tablets.
Sorafenib Mylan should be swallowed, washed down with a glass of water, on an empty stomach or with meals with low or moderate fat content. The medicine should not be taken with high-fat meals, as this may reduce the effectiveness of Sorafenib Mylan. If a high-fat meal is planned, 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 the doctor. In case of doubts, consult the 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 bloodstream.
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 Mylan than recommended

The doctor should be informed immediatelyif the person prescribed Sorafenib Mylan (or anyone else) has taken a dose higher than recommended. Taking too much Sorafenib Mylan may increase the risk of side effects or worsen them, especially diarrhea and skin reactions. The doctor may recommend discontinuing treatment with this medicine.

Missing a dose of Sorafenib Mylan

If the patient misses a dose, they should take it as soon as they remember. If the next dose is due soon, the missed dose should be skipped, and treatment should continue as usual. A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, Sorafenib Mylan can cause side effects, although not everyone will experience them. This medicine may also affect the results of some blood tests.

Very common:

May occur in more than 1 in 10 people

• diarrhea
• nausea (vomiting)
• feeling of weakness or fatigue (fatigue)
• pain (including pain in the mouth, abdominal pain, bone pain, headache, tumor pain)
• hair loss (alopecia)
• redness or pain in the hands or feet (hand-foot syndrome)
• itching or rash
• vomiting
• bleeding (including cerebral, gastrointestinal, respiratory, 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 occur in up to 1 in 10 people

• flu-like symptoms
• indigestion (dyspepsia)
• difficulty swallowing (dysphagia)
• inflammation or dryness in the mouth, tongue pain (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 of the hands and feet, 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
• 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 (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)
• watery discharge from the 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 occur in up to 1 in 100 people

• inflammation of the stomach lining (gastritis)
• 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 (hyperbilirubinemia)
• allergic reactions (including skin reactions and hay fever)
• dehydration
• breast enlargement (gynecomastia)
• breathing difficulties (lung disease)
• eczema
• increased thyroid activity (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• extremely high blood pressure
• perforation of the gastrointestinal tract (gastrointestinal perforation)
• reversible posterior leukoencephalopathy, 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 occur in 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)
• rash similar to 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 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)

Unknown:

frequency cannot be estimated from available data

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

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. 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 4921 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Sorafenib Mylan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry datestated on the carton and blister after: EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Mylan 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 (E172).

• 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 (E172).

What Sorafenib Mylan looks like and contents of the pack

Sorafenib Mylan 200 mg film-coated tablets are red-brown, round, biconvex film-coated tablets, with "200" embossed on one side and smooth on the other, with a diameter of 12.0 mm ± 5%.
They are packaged in blisters of aluminum/PVC/PE/PVDC with printed abbreviations of the days of the week in a cardboard box.
They are packaged in perforated unit dose blisters of aluminum/PVC/PE/PVDC with printed abbreviations of the days of the week in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
13 Dublin
Ireland

Manufacturer:

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 about the medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400
Date of last revision of the leaflet:May 2023