Sunitinib Eugia

Leaflet accompanying the packaging: information for the user

Sunitinib Eugia, 12.5 mg, hard capsules

Sunitinib Eugia, 25 mg, hard capsules

Sunitinib Eugia, 50 mg, hard capsules

Sunitinib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

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

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

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

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestine cancer, when imatinib (another anticancer 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 tumors (pNET) (tumors that develop from hormone-producing cells in the pancreas), which are progressing or cannot be removed surgically.

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

2. Important information before taking Sunitinib Eugia

When not to take Sunitinib Eugia

Warnings and precautions

Before starting treatment with Sunitinib Eugia, you should discuss it with your doctor or pharmacist:

• If you have high blood pressure. Sunitinib Eugia may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Eugia, and you may need to be treated with blood pressure-lowering medicines.
• If you have or have had blood disorders, bleeding, or bruising. Treatment with Sunitinib Eugia may increase the risk of bleeding or changes in the number of certain blood cells, which can cause anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, there may be a higher risk of bleeding. You should tell your doctor about any bleeding during treatment with Sunitinib Eugia.
• If you have heart disease. Sunitinib Eugia may cause heart disease. You should tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If you have heart rhythm disorders. Sunitinib Eugia may cause abnormal heart rhythm. During treatment with Sunitinib Eugia, your doctor may perform an electrocardiogram to assess these disorders. You should tell your doctor if you experience dizziness, fainting, or abnormal heart rhythm during treatment with Sunitinib Eugia.
• If you have recently had blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. You should contact 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 (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have or have had damage to the smallest blood vessels called microangiopathic hemolytic anemia. You should tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid gland disorders. Sunitinib Eugia may cause thyroid gland disorders. You should tell your doctor if you easily get tired, feel colder than others, or experience a deepened voice during treatment with Sunitinib Eugia. Your doctor should check your thyroid function before starting treatment with Sunitinib Eugia and regularly during treatment. If your thyroid gland does not produce enough thyroid hormone, you may need to be treated with a thyroid hormone replacement.
• If you have or have had disorders of the pancreas or gallbladder. You should 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 or have had liver disease. You should inform your doctor if you experience any of the following symptoms of liver function disorders: 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 liver function before starting treatment with Sunitinib Eugia, during treatment, and if there are clinical signs.

with the following symptoms of liver function disorders: 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 liver function before starting treatment with Sunitinib Eugia, during treatment, and if there are clinical signs.

• If you have or have had kidney disease. 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. The medicine is usually discontinued in patients before surgery. Your doctor will decide when to restart Sunitinib Eugia.
• You are advised to have a dental check-up before starting treatment with Sunitinib Eugia.
• If you experience mouth pain, toothache, and/or jaw pain, swelling or ulceration of the mouth, numbness or feeling of heaviness in the jaw, or tooth mobility, you should immediately inform your oncologist and dentist.
• If you need invasive dental treatment or oral surgery, you should inform your dentist about taking Sunitinib Eugia, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken due to another disease.
• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, "pyoderma gangrenosum" (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening) may occur. You should immediately contact your doctor if you experience symptoms of infection around a skin lesion, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after discontinuation of sunitinib treatment. During sunitinib treatment, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches with a target-like shape or round patches, often with centrally located blisters. The rash may transform into widespread blisters or peeling of the skin and may be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should immediately consult your doctor.
• If you have or have had seizures. You should inform 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 it is necessary to adjust the dose of the anti-diabetic medicine to minimize the risk of low blood sugar. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Eugia is not recommended for use in patients under 18 years of age.

Sunitinib Eugia and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, as well as any medicines you plan to take.
Some medicines may affect the level of Sunitinib Eugia in your body. You should inform your doctor if you are taking medicines containing 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 allergies and/or respiratory disorders or skin diseases)
• 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 disorders

Sunitinib Eugia with food and drink

While taking Sunitinib Eugia, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitinib Eugia.
Women who are breastfeeding should inform their doctor. You should not breastfeed while taking Sunitinib Eugia.

Driving and using machines

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

Sunitinib Eugia contains sodium

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

3. How to take Sunitinib Eugia

You should always take this medicine exactly as your doctor has told you. If you are unsure, you should ask your doctor.
Your doctor will prescribe the appropriate dose for you, depending on the type of cancer.
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 the medicine), in 6-week treatment cycles.
• pNET: the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the appropriate dose for you and whether you should stop taking Sunitinib Eugia.
Sunitinib Eugia can be taken with or without food.

Taking a higher dose of Sunitinib Eugia than recommended

If you have taken too many capsules, you should contact your doctor immediately.
Medical attention may be necessary.

Missing a dose of Sunitinib Eugia

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Sunitinib Eugia can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following serious side effects (see also "Important information before taking Sunitinib Eugia").
Heart disease. You should tell your doctor if you feel extremely tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, which can include heart failure and problems with the heart muscle (cardiomyopathy).
Lung disease or breathing difficulties. You should 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 move to the lungs.
Kidney function disorders. You should tell your doctor if you experience disturbed or absent urination, which may be a sign of kidney failure.
Bleeding. You should tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitinib Eugia: painful, swollen stomach (abdomen); vomiting blood; black, tarry stools; blood in the urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor lysis syndrome leading to intestinal perforation. You should tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the 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 number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, deep allergic rash.
• Mouth pain/oral discomfort, mouth ulcers/inflammation of the mucous membranes of the mouth, dry mouth, changes in taste, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss of/decreased appetite.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Arm and leg pain.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia (hand-foot syndrome), 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 of severe infection (sepsis), which can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Flu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing or loss of swallowing ability.
• Burning sensation or pain in the mouth, inflammation of the mucous membranes of the digestive tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle cramps.
• Dryness of the nasal mucous membranes, feeling of nasal congestion.
• Excessive tearing.
• Disorders of skin sensation, itching, skin peeling and inflammation, 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 areas (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood flow to the heart.
• Changes in heart electrical activity or rhythm disorders.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain (stomach) caused by pancreatitis.
• Tumor lysis syndrome leading to intestinal perforation (see section 2).
• Inflammation (swelling and 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 ulceration of the mouth, numbness or feeling of heaviness in the jaw, or tooth mobility. 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 muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay fever, skin rash, itching, hives, swelling of any part of the body, and breathing difficulties.

any part of the body, and breathing difficulties.

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

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

• Severe skin and mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor 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 brain changes, which can cause a syndrome of symptoms including headache, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Hepatitis.
• Thyroid gland inflammation.
• Damage to the smallest blood vessels called microangiopathic hemolytic anemia.

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 side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Eugia

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, bottle, and blister after: EXP. The expiry date refers to the last day of the month stated.
• There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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

6. Contents of the packaging and other information

What Sunitinib Eugia contains

• The active substance of Sunitinib Eugia 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.
• 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 strengths), red iron oxide (E 172), indigo carmine (E 132) (for 25 mg and 50 mg strengths), gelatin.
Printing ink: shellac (E 904), titanium dioxide (E 171) (for 12.5 mg and 25 mg strengths), black iron oxide (E 172) (for 50 mg strength), potassium hydroxide (E 525).

What Sunitinib Eugia looks like and contents of the pack

Hard capsule
Sunitinib Eugia, 12.5 mg, hard capsules
The hard gelatin capsules are size 4, with a red, opaque cap and a red, opaque body, with white printing "S12.5" on the body, containing yellow to orange granules. The approximate size of the capsule is about 14 mm.
Sunitinib Eugia, 25 mg, hard capsules
The hard gelatin capsules are size 3, with an olive-green, opaque cap and a red, opaque body, with white printing "S25" on the body, containing yellow to orange granules. The approximate size of the capsule is about 16 mm.
Sunitinib Eugia, 50 mg, hard capsules
The hard gelatin capsules are size 2, with an olive-green, opaque cap and an olive-green, opaque body, with black printing "S50" on the body, containing yellow to orange granules. The approximate size of the capsule is about 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 authorization holder and manufacturer/importer

Marketing authorization 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 authorized 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: