Sunitinib Eugia

Package Leaflet: Information for the User

Sunitinib Eugia, 12.5 mg, hard capsules

Sunitinib Eugia, 25 mg, hard capsules

Sunitinib Eugia, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Sunitinib Eugia is and what it is used for

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

• Gastrointestinal stromal tumour (GIST), a type of stomach and intestinal 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), tumours that arise from hormone-producing cells in the pancreas, which are progressing or cannot be removed by surgery.

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

2. Before you take Sunitinib Eugia

When not to take Sunitinib Eugia

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

Warnings and precautions

Before taking Sunitinib Eugia, tell your doctor or pharmacist:

• If you have high blood pressure. Sunitinib Eugia may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Eugia, and you may need to take medicines to lower your blood pressure.
• If you have or have had bleeding or blood disorders. Treatment with Sunitinib Eugia may increase the risk of bleeding or changes in blood cell counts, 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 Sunitinib Eugia.
• If you have heart problems. Sunitinib Eugia may cause heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling in your feet or ankles.
• If you have irregular heart rhythms. Sunitinib Eugia may cause irregular heart rhythms. During treatment with Sunitinib Eugia, your doctor may perform an electrocardiogram to check for these irregularities. Tell your doctor if you experience dizziness, fainting, or irregular heart rhythms while taking Sunitinib Eugia.
• If you have recently had blood clots in your veins or arteries, including stroke, heart attack, or deep vein thrombosis. 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, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.
• If you have thyroid problems. Sunitinib Eugia may cause thyroid problems. Tell your doctor if you feel very tired, feel colder than others, or have a hoarse voice while taking Sunitinib Eugia. Your doctor should check your thyroid function before starting Sunitinib Eugia and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take 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 Sunitinib Eugia, during treatment, and if you experience any symptoms.

and

• If you have kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery. Sunitinib Eugia may affect wound healing. Sunitinib Eugia is usually stopped before surgery, and your doctor will decide when to restart it.
• You are advised to have a dental check-up before starting treatment with Sunitinib Eugia.
• If you experience pain in your mouth, teeth, or jaw, swelling or sores in your mouth, numbness or feeling of heaviness in your jaw, or loosening of a tooth, tell your doctor or dentist immediately.
• If you need to have invasive dental work or surgery, tell your dentist that you are taking Sunitinib Eugia, 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 "pyoderma gangrenosum" (painful skin ulcers) 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 sunitinib treatment. While taking sunitinib, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as red patches with a target-like shape or round 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-mentioned 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 vision loss.
• If you have diabetes. If you have diabetes, your blood sugar levels should be regularly checked to assess whether the dose of your anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. Tell your doctor immediately if you experience symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Eugia is not recommended for use in children and adolescents under 18 years of age.

Sunitinib Eugia with 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 medicines.

• Ketoconazole, 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 allergies and respiratory or skin disorders)
• Phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions
• Herbal medicines containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety

Sunitinib Eugia with food and drink

Do not drink grapefruit juice while taking Sunitinib Eugia.

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 Sunitinib Eugia.

Do not breast-feed while taking Sunitinib Eugia.

Driving and using machines

If you experience dizziness or extreme fatigue, be careful when driving or operating machinery.

Sunitinib Eugia contains sodium

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

3. How to take Sunitinib Eugia

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 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 Sunitinib Eugia), in 6-week cycles.
• For pNET: the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the correct dose for you and whether you should stop taking Sunitinib Eugia.

Sunitinib Eugia can be taken with or without food.

If you take more Sunitinib Eugia than you should

If you take too many capsules, contact your doctor immediately.

Medical attention may be necessary.

If you forget to take Sunitinib Eugia

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 serious side effects (see also "Important information before taking Sunitinib Eugia").

Heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling in your feet or ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).

Lung problems or difficulty breathing. 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, where blood clots move to the lungs.

Kidney problems. Tell your doctor if you experience changes in urination or lack of urination, which may be a sign of kidney failure.

Bleeding. Tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitinib Eugia: painful, swollen abdomen (stomach); 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 lysis syndrome leading to intestinal perforation. Tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.

Other side effects of Sunitinib Eugia may include:

Very common: may affect more than 1 in 10 people

• Decreased platelet count, red blood cells, or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, weakness.
• Swelling caused by fluid accumulation under the skin and around the eyes, deep allergic rash.
• Mouth pain/inflammation, mouth sores/inflammation, dry mouth, taste changes, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair colour changes, rash on palms and soles, rash, dry skin.
• Coughing.
• Fever.
• Sleep disturbances.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient blood flow to the heart muscle 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 after a severe infection (sepsis), which can cause tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Protein loss in urine, sometimes causing swelling.
• Flu-like symptoms.
• Abnormal blood test results, including elevated liver and pancreatic 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, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle cramps.
• Dryness of the nasal mucous membranes, feeling of nasal congestion.
• Excessive tear production.
• Skin sensitivity disorders, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensitivity disorders in the limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the area around the anus and genital organs (see section 2).
• Stroke.
• Heart attack caused by a blockage or narrowing of the coronary arteries.
• Changes in the electrical or rhythmic activity of the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreatitis.
• Tumour lysis syndrome leading to intestinal perforation.
• Inflammation of the gallbladder (cholecystitis) with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Mouth pain, tooth pain, and/or jaw pain, swelling or sores in the mouth, numbness or feeling of heaviness in the jaw, or tooth loosening. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased energy expenditure at rest.
• Impaired wound healing after surgery.
• Increased activity of the enzyme creatine phosphokinase in the blood.
• Excessive allergic reaction, including hay fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing.

and

• Inflammation of the large intestine (colitis, ischemic colitis).

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

• Severe skin and mucous membrane reactions (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, cloudy urine, 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, disorientation, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (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 rupture of the wall of a blood vessel (aneurysm and arterial dissection).
• Lack of energy, disorientation, drowsiness, loss of consciousness/coma - these symptoms may be signs of a harmful effect on the brain caused by high levels of ammonia in the blood (hyperammonemic encephalopathy).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Eugia

• 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.
• No special storage precautions are necessary.

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.

• Do not use this medicine if the packaging is damaged or shows signs of tampering.

6. Contents of the pack and other information

What Sunitinib Eugia contains

• The active substance is sunitinib. Each hard capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib. Each hard capsule contains sunitinib malate equivalent to 25 mg of sunitinib. Each hard capsule contains sunitinib malate equivalent to 50 mg of sunitinib.
• The other ingredients are: Capsule content: mannitol, croscarmellose sodium, povidone, magnesium stearate.

Capsule shell: titanium dioxide (E 171), yellow iron oxide (E 172) (for 25 mg and 50 mg), red iron oxide (E 172), indigo carmine (E 132) (for 25 mg and 50 mg), gelatin.

Printing ink: shellac (E 904), titanium dioxide (E 171) (for 12.5 mg and 25 mg), black iron oxide (E 172) (for 50 mg), potassium hydroxide (E 525).

What Sunitinib Eugia looks like and contents of the pack

Hard capsule

Sunitinib Eugia, 12.5 mg, hard capsules

Red, opaque hard gelatin capsules, size 4, with a white imprint "S12.5" on the body, containing yellow to orange granules. The approximate capsule size is 14 mm.

Sunitinib Eugia, 25 mg, hard capsules

Olive green, opaque hard gelatin capsules, size 3, with a white imprint "S25" on the body, containing yellow to orange granules. The approximate capsule size is 16 mm.

Sunitinib Eugia, 50 mg, hard capsules

Olive green, opaque hard gelatin capsules, size 2, with a black imprint "S50" on the body, containing yellow to orange granules. The approximate capsule size is 18 mm.

Sunitinib Eugia, 12.5 mg, 25 mg, and 50 mg hard capsules are available in blisters, in cardboard boxes, containing 28, 30, 50, 56, 60, 70, 84, 90, 98, 100, 110, and 120 hard capsules.

Sunitinib Eugia, 12.5 mg, 25 mg, and 50 mg hard capsules are available in HDPE bottles, in cardboard boxes, containing 28 hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Eugia Pharma (Malta) Limited

Vault 14, level 2

Valletta Waterfront

Floriana, FRN 1914

Malta

e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

France:

SUNITINIB ARROW 12.5 mg, gélule

SUNITINIB ARROW 25 mg, gélule

SUNITINIB ARROW 50 mg, gélule

Germany:

Sunitinib PUREN 12.5 mg Hartkapseln

Sunitinib PUREN 25 mg Hartkapseln

Sunitinib PUREN 37.5 mg Hartkapseln

Sunitinib PUREN 50 mg Hartkapseln

Netherlands:

Sunitinib Eugia 12.5 mg/25 mg/50 mg, harde capsules

Poland:

Sunitinib Eugia

Portugal:

Sunitinib Generis

Spain:

Sunitinib Eugia 12.5 mg cápsulas duras EFG

Sunitinib Eugia 25 mg cápsulas duras EFG

Sunitinib Eugia 50 mg cápsulas duras EFG

Sweden:

Sunitinib Eugia 12.5 mg/25 mg/37.5 mg/50 mg harda kapslar

Date of last revision of the leaflet: