Sunitinib Milan

Package Leaflet: Information for the User

Sunitynib Mylan, 12.5 mg, hard capsules

Sunitynib Mylan, 25 mg, hard capsules Sunitynib Mylan, 37.5 mg, hard capsules

Sunitynib Mylan, 50 mg, hard capsules

Sunitinib

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Sunitynib Mylan contains the active substance sunitinib, which is a protein kinase inhibitor.
Sunitynib Mylan is used to treat cancers. It works by inhibiting the activity of a specific group of proteins, which are involved in the growth and spread of cancer cells.
Sunitynib Mylan is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumour (GIST), a type of stomach and intestine cancer, when imatinib (another anti-cancer medicine) has stopped working or the patient cannot take it;
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• Pancreatic neuroendocrine tumours (pNET), cancers that start in the hormone-producing cells of the pancreas, which are in an advanced stage and cannot be surgically removed.

If you have any questions about how Sunitynib Mylan works or why it has been prescribed for you, ask your doctor.

2. Before you take Sunitynib Mylan

When you should not take Sunitynib Mylan

• If you are allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Sunitynib Mylan, tell your doctor:

• If you have high blood pressure. Sunitynib Mylan may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitynib Mylan, and you may need to take medicines to lower your blood pressure.
• If you have or have had bleeding or blood clotting problems. Treatment with Sunitynib Mylan may increase the risk of bleeding or changes in the number of certain blood cells, which can cause anaemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent blood clots, there may be a higher risk of bleeding. Tell your doctor about any bleeding during treatment with Sunitynib Mylan.
• If you have heart problems. Sunitynib Mylan may cause heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling of your feet or ankles.
• If you have irregular heartbeats. Sunitynib Mylan may cause irregular heartbeats. During treatment with Sunitynib Mylan, your doctor may perform an electrocardiogram to check for these irregularities. Tell your doctor if you feel dizzy, faint, or have irregular heartbeats while taking Sunitynib Mylan.
• If you have recently had problems with blood clots in your veins and/or arteries (such as stroke, heart attack, deep vein thrombosis, or pulmonary embolism). Tell your doctor immediately if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, or headache or dizziness.
• If you have or have had an aneurysm (a bulge or weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have or have had a condition called thrombotic microangiopathy (a disorder that affects the small blood vessels). Tell your doctor if you experience fever, fatigue, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems. Sunitynib Mylan may cause thyroid problems. Tell your doctor if you feel very tired, feel colder than others, or have a hoarse voice while taking Sunitynib Mylan. Your doctor should check your thyroid function before starting Sunitynib Mylan and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take a replacement thyroid hormone.
• If you have or have had pancreas or gallbladder problems. Tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If you have liver problems. Tell your doctor if you experience any of the following symptoms of liver problems: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check your liver function before starting Sunitynib Mylan, during treatment, and if you experience any symptoms.
• If you have kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery. Sunitynib Mylan may affect wound healing. The medicine is usually stopped before surgery, and your doctor will decide when to restart Sunitynib Mylan.
• You are advised to have a dental check-up before starting treatment with Sunitynib Mylan:
• -If you experience mouth pain, toothache, or jaw pain, swelling, or mouth ulcers, numbness, or a feeling of heaviness in the jaw, or tooth mobility, tell your doctor and dentist immediately.
• -If you need to have invasive dental procedures or surgery, tell your dentist that you are taking Sunitynib Mylan, especially if you are also taking or have taken bisphosphonates intravenously. Bisphosphonates are medicines used to prevent bone problems that may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders. While taking this medicine, you may experience a painful skin rash (pyoderma gangrenosum) or necrotizing fasciitis (a rapidly spreading infection of the skin and soft tissues that can be life-threatening). Tell your doctor immediately if you experience symptoms of infection around a skin wound, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after stopping Sunitynib Mylan. While taking this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as red patches similar to targets or circular patches, often with centrally located blisters. The rash may progress to widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above skin symptoms, tell your doctor immediately.
• If you have or have had seizures. Tell your doctor as soon as possible if you experience high blood pressure, headache, or loss of vision.
• If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of the anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you experience symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitynib Mylan is not recommended for patients under 18 years of age.

Sunitynib Mylan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal products.
Some medicines may affect the levels of Sunitynib Mylan in your body. Tell your doctor if you are taking medicines that contain the following active substances:

• ketokonazole, itraconazole - used to treat fungal infections,
• erythromycin, clarithromycin, rifampicin - used to treat infections,
• ritonavir - used to treat HIV infections,
• dexamethasone - a corticosteroid used in various diseases (such as allergic disorders and/or respiratory disorders or skin diseases),
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions,
• herbal products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Taking Sunitynib Mylan with food and drink

Do not drink grapefruit juice while taking Sunitynib Mylan.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitynib Mylan.
Do not breast-feed while taking Sunitynib Mylan.

Driving and using machines

If you experience dizziness or extreme tiredness, be careful when driving or using machines.

Sunitynib Mylan contains sodium

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

3. How to take Sunitynib Mylan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will prescribe the dose that is right for you, depending on the type of cancer you have.
For patients being treated for:

• GIST or MRCC, the usual dose is 50 mg taken once a day for 28 days (4 weeks), followed by a 14-day (2-week) break (without taking the medicine), in 6-week cycles of treatment.
• pNET, the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the correct dose for you and when to stop taking Sunitynib Mylan.
Sunitynib Mylan can be taken with or without food.

If you take more Sunitynib Mylan than you should

If you take too many capsules, contact your doctor immediately. You may need urgent medical attention.

If you forget to take Sunitynib Mylan

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects (see also section 2 'Before you take Sunitynib Mylan'):
Heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling of your feet or ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).
Lung or breathing problems. Tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney problems. Tell your doctor if you experience changes in urination or lack of urination, which may be symptoms of kidney failure.
Bleeding. Tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitynib Mylan: stomach pain and swelling; vomiting blood; black, tarry stools; blood in urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumour rupture leading to perforation of the intestine. Tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.
Other side effects of Sunitynib Mylan may include:

• Very common: may affect more than 1 in 10 people
• Decreased number of platelets, red blood cells, and/or white blood cells (such as neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep.
• Pain and/or irritation in the mouth, painful mouth sores and/or inflammation, and/or dryness of the mouth, changes in taste, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of and/or decreased appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and/or discoloration, excessive skin pigmentation, hair color changes, rash on palms and soles, rash, dry skin.
• Coughing.
• Fever.
• Difficulty sleeping.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient blood supply to the heart due to a blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication following a severe infection (sepsis) that can lead to tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Protein loss in urine, sometimes causing swelling.
• Flu-like syndrome.
• Abnormal blood test results, including elevated liver and pancreas enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing, or loss of swallowing ability.
• Burning or painful tongue, inflammation of the mucous membranes of the digestive system, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle spasms.
• Dryness of the nasal mucous membranes, feeling of nasal congestion, excessive tearing.
• Disorders of skin sensation, itching, peeling, and inflammation of the skin, blisters, acne, nail discoloration, hair loss.
• Disorders of sensation in the limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the anal and genital area (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood flow to the heart.
• Changes in the electrical activity or rhythm of the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain (abdominal pain) caused by pancreatitis.
• Tumour rupture leading to perforation of the intestine.
• Inflammation (swelling or redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Mouth pain, toothache, and/or jaw pain, swelling, or mouth ulcers, numbness, or a feeling of heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones leading to increased resting metabolism.
• Impaired wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1000 people

• Severe skin reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome, a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, lack of urine clarity, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to kidney damage and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain, which can cause a syndrome of symptoms including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin rash (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damage to the smallest blood vessels called thrombotic microangiopathy.

Frequency not known (frequency cannot be estimated from the available data)

• Enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and arterial dissection).
• Lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be signs of a toxic effect of high ammonia levels in the blood on the brain (hyperammonemic encephalopathy).

Reporting of side effects

If you experience any side effects, talk to your doctor. Side effects can be reported to the national reporting system listed below.
Side effects can also be reported to the Marketing Authorisation Holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitynib 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 carton, bottle, and blister after EXP. The expiry date refers to the last day of that month.
• There are no special storage instructions for this medicine.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

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 Sunitynib Mylan contains

• The active substance is sunitinib.

Sunitynib Mylan, 12.5 mg, hard capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitynib Mylan, 25 mg, hard capsules
Each capsule contains 25 mg of sunitinib.
Sunitynib Mylan, 37.5 mg, hard capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitynib Mylan, 50 mg, hard capsules
Each capsule contains 50 mg of sunitinib.

• Other ingredients are: Capsule content:Microcrystalline cellulose, mannitol, sodium croscarmellose (see section 2 Sunitynib Mylan contains sodium), povidone K30, magnesium stearate

Sunitynib Mylan, 12.5 mg, hard capsules

• Capsule shell:Red iron oxide (E172), titanium dioxide (E171), gelatin.
• White printing ink:Shellac, titanium dioxide (E171), propylene glycol.

Sunitynib Mylan, 25 mg, hard capsules

• Capsule shell:Black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• White printing ink:Shellac, titanium dioxide (E171), propylene glycol.

Sunitynib Mylan, 37.5 mg, hard capsules

• Capsule shell:Yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• Black printing ink:Shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide.

Sunitynib Mylan, 50 mg, hard capsules

• Capsule shell:Black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• White printing ink:Shellac, titanium dioxide (E171), propylene glycol.

What Sunitynib Mylan looks like and contents of the pack

Sunitynib Mylan, 12.5 mg, hard capsules
Orange capsules (size 4) with orange cap and body, with white printing "12.5 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, 25 mg, hard capsules
Caramel capsules (size 3) with orange cap and body, with white printing "25 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, 37.5 mg, hard capsules
Yellow capsules (size 2) with yellow cap and body, with black printing "37.5 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan, 50 mg, hard capsules
Caramel capsules (size 1) with caramel cap and body, with white printing "50 mg" on the body, containing yellow to orange granules.
Sunitynib Mylan hard capsules are available in blisters containing 28 hard capsules, in perforated unit dose blisters containing 28 x 1 hard capsules, in perforated unit dose blisters containing 30 x 1 hard capsules, and in plastic bottles containing 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Pharmacare Premium Ltd
HHF003 Hal Far Industrial Estate
BBG3000 Birzebbugia Malta
For further information, contact the Marketing Authorisation Holder:

Viatris Healthcare Sp. z o.o.

Tel.: +48 22 546 64 00
Date of last revision of the leaflet:September 2024