Sorafenib Mylan: detailed information

Package leaflet: Information for the patient

Sorafenib Mylan 200 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sorafenib Mylan is and what it is used for
What you need to know 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 to treat liver cancer (hepatocellular carcinoma).
Sorafenib Mylan is also used to treat advanced kidney cancer (advanced renal cell carcinoma) when the disease has reached an advanced stage and standard therapy has either failed to control it or is considered unsuitable.
Sorafenib Mylan is used to treat thyroid cancer (differentiated thyroid carcinoma).
Sorafenib Mylan is a so-called multi-kinase inhibitor. It works by slowing down the growth rate of tumor cells and by blocking the blood supply required for tumor cells to grow.

2. What you need to know before taking Sorafenib Mylan

Do not take Sorafenib Mylan

if you are allergic to sorafenib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sorafenib Mylan.
Be especially careful with Sorafenib Mylan, particularly if

Skin problems occur. Sorafenib Mylan can cause rashes and skin reactions, especially on the hands and feet. These effects can usually be managed by your doctor. Otherwise, your doctor may suspend or completely discontinue treatment.
You have high blood pressure. Sorafenib Mylan can cause an increase in blood pressure; your doctor will regularly monitor your blood pressure and may prescribe medication to treat high blood pressure.
You have or have had an aneurysm (a weakening and bulging of a blood vessel wall) or a tear in the wall of a blood vessel.
You have diabetes. In diabetic patients, blood glucose levels should be monitored regularly to determine whether the dose of antidiabetic medication needs to be adjusted, in order to minimize the risk of low blood glucose levels.
You have bleeding problems or are taking warfarin or phenprocoumon. Treatment with Sorafenib Mylan may increase the risk of bleeding. If you are taking warfarin or phenprocoumon, medicines that thin the blood to prevent clotting, there may be an increased risk of bleeding.
You have chest pain or heart problems. Your doctor may decide to suspend or completely discontinue treatment.
You have a heart disorder, such as an electrical conduction abnormality called “QT interval prolongation”.
You are scheduled for or have recently undergone surgery. Sorafenib Mylan may affect wound healing. If you are scheduled for surgery, your treatment with Sorafenib Mylan will likely be suspended. Your doctor will decide when to restart treatment.
You are being treated with irinotecan or docetaxel, which are also anticancer medicines. Sorafenib Mylan may increase the effects, and particularly the side effects, of these medicines.
You are taking neomycin or other antibiotics. The effectiveness of Sorafenib Mylan may be reduced.
You have severe liver impairment. You may experience a worsening of side effects when taking this medicine.
You have reduced kidney function. Your doctor will monitor your fluid and electrolyte balance.
Fertility. Sorafenib Mylan may reduce fertility in both men and women. If this concerns you, speak to your doctor.
Gastrointestinal perforation may occur during treatment (see section 4: Possible side effects). In such a case, your doctor will discontinue treatment.
If you have thyroid cancer, your doctor will monitor calcium and thyroid hormone levels in your blood.
If you experience any of the following symptoms, contact your doctor immediately, as these may indicate a potentially life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These symptoms may be caused by a series of metabolic complications that can occur during cancer treatment, due to the breakdown products of dying tumor cells (tumor lysis syndrome, TLS), which may lead to impaired kidney function and acute kidney failure (see also section 4: Possible side effects).

Inform your doctor if any of these conditions apply to you. You may require treatment for these conditions, or your doctor may adjust your dose of Sorafenib Mylan or discontinue treatment altogether (see also section 4: Possible side effects).

Children and adolescents
Sorafenib Mylan has not yet been studied in children and adolescents.

Other medicines and Sorafenib Mylan
Some medicines may affect Sorafenib Mylan or be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed below or any other medicine, including those not requiring a prescription:

Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
St. John’s wort, a herbal remedy for depression
Phenytoin, carbamazepine, or phenobarbital, treatments for epilepsy and other conditions
Dexamethasone, a corticosteroid used for various diseases
Warfarin or phenprocoumon, anticoagulants used to prevent blood clots
Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, used in the treatment of cancer
Digoxin, used in the treatment of mild to moderate heart failure

Pregnancy and breastfeeding
Avoid becoming pregnant while being treated with Sorafenib Mylan. If you are of childbearing age, you must use an effective method of contraception during treatment. If you become pregnant while taking Sorafenib Mylan, inform your doctor immediately; your doctor will decide whether treatment should continue.
You must not breastfeed during treatment with Sorafenib Mylan, as this medicine may interfere with the growth and development of the infant.

Driving and using machines
There are no known reasons to believe that Sorafenib Mylan affects the ability to drive vehicles or operate machinery.

Sorafenib Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Sorafenib Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Sorafenib Mylan in adults is two 200 mg tablets twice daily.
This corresponds to a daily dose of 800 mg, or four tablets per day.
Take Sorafenib Mylan tablets with a glass of water, on an empty stomach or with food that is low or moderately fat. Do not take this medicine with highly fatty meals, as they may reduce its effectiveness. If you plan to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
It is important to take this medicine at approximately the same time each day to maintain a constant concentration in the blood.
This medicine is usually taken for as long as clinical benefit is observed and you do not experience intolerable side effects.
If you take more Sorafenib Mylan than you should
Tell your doctor immediately if you, or anyone else, has taken more than the prescribed dose. Taking too much Sorafenib Mylan may make side effects more likely or more severe, especially diarrhoea and skin reactions. Your doctor may instruct you to stop taking this medicine.
If you forget to take Sorafenib Mylan
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for the forgotten tablet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. This medicine may also alter the results of certain blood tests.

Very common:
may affect more than 1 in 10 people

Diarrhea
Feeling unwell (nausea)
Feeling weak or tired (fatigue)
Pain (including mouth, abdominal pain, headache, bone pain, cancer pain)
Hair loss (alopecia)
Redness or pain on the palms of the hands or soles of the feet (hand-foot skin reaction)
Itching or rash
Vomiting
Bleeding (including brain hemorrhage, intestinal wall hemorrhage, and respiratory tract hemorrhage)
High blood pressure or increased 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 illness
Indigestion (dyspepsia)
Difficulty swallowing (dysphagia)
Inflammation or dryness of the mouth, tongue pain (stomatitis and mucosal inflammation)
Low levels of calcium in the blood (hypocalcemia)
Low levels of potassium in the blood (hypokalemia)
Low levels of glucose in the blood (hypoglycemia)
Muscle pain (myalgia)
Sensory disturbances in fingers and toes, including tingling and numbness (peripheral sensory neuropathy)
Depression
Erectile problems (impotence)
Voice changes (dysphonia)
Acne
Inflamed, dry or peeling skin (dermatitis, skin desquamation)
Heart failure
Heart attack (myocardial infarction) or chest pain
Tinnitus (ringing in the ears)
Kidney failure
High levels of protein in the urine (proteinuria)
General weakness or loss of strength (asthenia)
Reduced number of white blood cells (leucopenia and neutropenia)
Reduced number of red blood cells (anemia)
Low number of platelets in the blood (thrombocytopenia)
Inflammation of hair follicles (folliculitis)
Reduced thyroid activity (hypothyroidism)
Low levels of sodium in the blood (hyponatremia)
Changes in taste sensation (dysgeusia)
Flushing of the face and often other areas of the skin (hot flushes)
Runny nose (rhinorrhea)
Heartburn (gastroesophageal reflux disease)
Skin tumor (keratoacanthoma/squamous 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 (gastritis)
Stomach (abdominal) pain due to 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-type reactions (including skin reactions and hives)
Dehydration
Breast enlargement (gynecomastia)
Difficulty breathing (lung disease)
Eczema
Overactivity of the thyroid (hyperthyroidism)
Multiple skin rashes (erythema multiforme)
High blood pressure
Gastrointestinal perforation
Reversible swelling in the back part of the brain that may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision (reversible posterior leukoencephalopathy syndrome)
Sudden, severe allergic reaction (anaphylactic reaction)

Rare:
may affect up to 1 in 1,000 people

Allergic reaction with swelling of the skin (e.g. face, tongue) that may cause difficulty breathing and swallowing (angioedema)
Abnormal heart rhythm (QT prolongation)
Inflammation of the liver, which may lead to nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
Skin eruption resembling sunburn appearing on areas previously exposed to radiotherapy, which may be severe (radiation-like dermatitis)
Severe skin and/or mucosal membrane reactions that may include painful blisters and fever, with shedding of large areas of skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
Abnormal muscle damage that may lead to kidney problems (rhabdomyolysis)
Kidney damage causing loss of large amounts of protein in the urine (nephrotic syndrome)
Inflammation of blood vessels in the skin that may appear as a rash (leukocytoclastic vasculitis)

Not known:
frequency cannot be estimated from the available data

Impaired brain function which may be associated with, for example, drowsiness, behavioral changes, or confusion (encephalopathy)
Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (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 of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Sorafenib Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after "Exp" and on each blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sorafenib Mylan contains

The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
The other components 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), red iron oxide (E172). See section 2 "Sorafenib Mylan contains sodium".

Description of the appearance of Sorafenib Mylan and contents of the pack
The 200 mg film-coated tablets of Sorafenib Mylan are red-brown in colour, round, biconvex, with "200" printed on one side and smooth on the other side, with a diameter of 12 mm.
They are available in packs of 112 film-coated tablets in aluminium-PVC/PE/PVDC blisters.
They are also available in packs of 112 x 1 film-coated tablets in perforated unit-dose blisters made of aluminium-PVC/PE/PVDC.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
Remedica Ltd
Aharnon Street,
Limassol Industrial Estate,
Limassol 3056, Cyprus

PharOS MT Ltd,
HF62X, Hal Far Industrial Estate,
Birżebbuġa BBG3000, Malta