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
Sunitinibum
Please 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Sunitinib Eugia is and what it is used for
2. What you need to know before taking 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 sunitinib as the active substance, which is a protein kinase inhibitor.
The medicine is used in the treatment of cancers by inhibiting the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib Eugia is used in the treatment of the following types of cancer in adults:

• Gastrointestinal stromal tumour (GIST), a type of stomach and intestinal cancer when imatinib (another anticancer medicine) is no longer effective or cannot be used.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Advanced pancreatic neuroendocrine tumours (pNET) (tumours arising from hormone-producing cells in the pancreas) that are progressing or cannot be surgically removed.

If you have any questions about how Sunitinib Eugia works or why this medicine has been prescribed, please consult your doctor.

2. Important information before taking Sunitinib Eugia

When not to take Sunitinib Eugia

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

Warnings and precautions
Before starting treatment with Sunitinib Eugia, discuss the following with your doctor or
pharmacist:

• If high blood pressure is present. Sunitinib Eugia may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Eugia, and you may need to be treated with antihypertensive medicines if necessary.

• If there are or have been in the past blood disorders, bleeding or bruising. Treatment with Sunitinib Eugia may increase the risk of bleeding or alter the number of certain blood cells, which may lead to anaemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, anticoagulant medicines used to prevent blood clots, there may be an increased risk of bleeding. Inform your doctor about any bleeding episodes during treatment with Sunitinib Eugia.

• If there are heart conditions. Sunitinib Eugia may cause heart problems. Inform your doctor if you experience unusual fatigue, shortness of breath, or swelling in your feet or ankles.

• If there are heart rhythm disorders. Sunitinib Eugia may cause irregular heart rhythms. During treatment with Sunitinib Eugia, your doctor may perform an electrocardiogram (ECG) to monitor for such disturbances. Inform your doctor if you experience dizziness, fainting, or irregular heartbeat while taking Sunitinib Eugia.

• If there have been recent venous and (or) arterial thromboses (types of blood vessels), including stroke, myocardial infarction, embolism, or thrombosis. Contact your doctor immediately if, during treatment with Sunitinib Eugia, you experience symptoms such as chest pain or tightness, pain in the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness.

• If you have or have previously had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

• If there is or has been in the past damage to the smallest blood vessels, known as thrombotic microangiopathy. Inform your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.

• If there are thyroid gland disorders. Sunitinib Eugia may cause thyroid problems. Inform your doctor if you feel unusually tired, feel colder than usual, or experience voice changes during treatment with Sunitinib Eugia. Your doctor should check thyroid function before starting treatment with Sunitinib Eugia and regularly during treatment. If the thyroid gland does not produce enough thyroid hormone, you may require replacement thyroid hormone therapy.

• If there are or have been in the past pancreatic disorders or gallbladder diseases. Inform your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be signs of pancreatitis or gallbladder inflammation.

• If there are or have been in the past liver diseases. Inform your doctor if, during treatment with Sunitinib Eugia, you experience any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin (jaundice), dark urine, or pain or discomfort in the upper right abdomen. Your doctor should order blood tests to monitor liver function before starting treatment with Sunitinib Eugia, during treatment, and whenever clinically indicated.

• If there are or have been in the past kidney diseases. Your doctor will monitor kidney function.

• If you are scheduled for surgery or have recently undergone surgery. Sunitinib Eugia may affect wound healing. The medicine is usually discontinued before surgery. Your doctor will decide when to restart Sunitinib Eugia.

• A dental examination is recommended before starting treatment with Sunitinib Eugia.

• If you experience pain in the mouth, tooth or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth, inform your oncologist and dentist immediately.

• If you require invasive dental treatment or dental surgery, inform your dentist that you are taking Sunitinib Eugia, especially if you are also taking or have previously taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken due to another condition.

• If there are or have been in the past skin and subcutaneous tissue disorders. While taking this medicine, you may develop "necrolytic erythema" (painful skin ulceration) or necrotizing fasciitis (rapidly spreading infection of the skin and/or soft tissues, which may be life-threatening). Contact your doctor immediately if you develop signs of infection around skin lesions, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of sunitinib treatment. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during sunitinib treatment. These initially appear as red, target-shaped or circular spots, often with centrally located blisters. The rash may progress to extensive blistering or skin peeling and may be life-threatening. If you develop a rash or any of the above-mentioned skin symptoms, contact your doctor immediately.

• If you have or have had seizures. Inform your doctor as soon as possible if you develop high blood pressure, headache, or vision loss.

• If you have diabetes. Blood glucose levels should be monitored regularly in diabetic patients to determine whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycaemia. Inform your doctor immediately if you experience symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents
Sunitinib Eugia is not recommended for patients under 18 years of age.
Sunitinib Eugia and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
Some medicines may affect the concentration of Sunitinib Eugia in the body. Inform your doctor if you are taking medicines containing any of the following active substances:

• ketoconazole, itraconazole – used to treat fungal infections
• erythromycin, clarithromycin, rifampicin – used to treat infections
• ritonavir – used to treat HIV infection
• dexamethasone – a corticosteroid used in various conditions (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

Sunitinib Eugia with food and drink
Do not drink grapefruit juice during treatment with Sunitinib Eugia.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitinib Eugia.
Breastfeeding women should inform their doctor. Breastfeeding is not recommended during treatment with Sunitinib Eugia.
Driving and operating machinery
If you experience dizziness or significant fatigue, exercise particular caution when driving or operating machinery.
Sunitinib Eugia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Sunitinib Eugia

This medicine should always be taken exactly as your doctor has advised. If in doubt, consult your doctor.
Your doctor will prescribe the appropriate dose depending on the type of tumour.
For patients being treated for:

• GIST or MRCC: the usual dose is 50 mg once daily for 28 days (4 weeks), followed by a 14-day (2-week) break (without medication), in 6-week treatment cycles.
• pNET: the usual dose is 37.5 mg once daily on a continuous basis.

Your doctor will determine the appropriate dose for you, as well as whether and when treatment with Sunitinib Eugia should be interrupted.
Sunitinib Eugia may be taken with or without food.
Taking more Sunitinib Eugia than recommended
If you take too many capsules, contact your doctor immediately. Medical assistance may be required.
Missing a dose of Sunitinib Eugia
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You should contact the doctor immediately if the patient experiences any of the following
serious side effects (see also "Important information before taking Sunitinib Eugia").
Heart problems. Tell the doctor if the patient feels very tired, has shortness of breath,
or swelling of the feet and ankles. These may be symptoms of heart problems, which may include
heart failure and problems with the heart muscle (cardiomyopathy).
Lung problems or difficulty breathing. Tell the doctor if the patient develops
a cough, chest pain, sudden shortness of breath, or coughs up blood. These may be
symptoms of a condition called pulmonary embolism, which occurs when blood clots
travel to the lungs.
Kidney function disorders. Tell the doctor if the patient experiences changes in
urination frequency or absence of urination, which may be signs of kidney failure.
Bleeding. Tell the doctor if the patient experiences 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.
Tumour lysis leading to intestinal perforation. Tell the doctor if the patient experiences
severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other side effects of Sunitinib Eugia may include:

Very common: may affect more than 1 in 10 people

• Decreased platelet count, red blood cells, and/or white blood cells (e.g. neutrophils).
• Shortness of breath.
• High blood pressure.
• Severe fatigue, loss of energy.
• Swelling due to fluid accumulation under the skin and around the eyes, deep allergic rash.
• Pain/irritation in the mouth, mouth ulcers/inflammation/dryness of the oral mucosa, taste disturbances, gastric disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain/distension, loss/reduced appetite.
• Reduced thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair color changes, rash on palms and soles, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood supply to the heart muscle due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention, including in the lung area.
• Infections.
• Complication following severe infection (blood infection), which may 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 pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or loss of swallowing ability.
• Burning or painful sensation of the tongue, inflammation of the gastrointestinal mucosa, 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 mucosa, sensation of nasal congestion.
• Excessive tearing.
• Skin sensation disturbances, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensory disturbances in limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flushes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening soft tissue infections, including around the anus and genital organs (see section 2).

• Stroke.

• Myocardial infarction caused by interruption or reduction of blood supply to the heart.

• Changes in electrical function or rhythm disturbances of the heart.

• Presence of fluid around the heart (pericardial effusion).

• Liver failure.

• Stomach (abdominal) pain due to inflammation of the pancreas.

• Tumour lysis leading to intestinal perforation.

• Inflammation (swelling and redness) of the gallbladder with or without gallstones.

• Formation of abnormal connections between one body cavity and another or to the skin.

• Mouth pain, tooth and/or jaw pain, swelling or ulceration of the oral mucosa, numbness or heaviness in the jaw, or loose teeth. These may be symptoms of jaw bone damage (osteonecrosis), see section 2.

• Excessive production of thyroid hormones leading to increased energy consumption by the body at rest.

• Impaired healing of surgical wounds.

• Increased activity of muscle enzyme (creatine phosphokinase) in blood.

• Excessive allergic reaction, including hay fever, skin rash, itching, hives, swelling
  of 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 reaction affecting the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome, a group of metabolic complications that may occur during cancer treatment. These complications are caused by products released from dying tumour cells and may 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 phosphate, and low calcium levels in blood), which may lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown that may cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain that may cause a syndrome of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels called thrombotic microangiopathy.

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

• Enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection).
• Lack of energy, disorientation, drowsiness, loss of consciousness/coma – these symptoms may indicate harmful effects on the brain caused by high levels of ammonia in the blood (hyperammonaemic encephalopathy).

Reporting of side effects
If any side effects occur, including any side effects not listed
in this leaflet, tell your doctor or pharmacist. Side effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 responsible entity.
Reporting side effects helps to provide more information on the
safety of using the 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 stated on the carton, bottle, and blister after: EXP. The expiry date refers to the last day of the stated month.
• There are no special storage instructions for this medicine.

Medicines must 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 the medicine 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.
• Other ingredients are:
  Capsule contents: mannitol, sodium croscarmellose, 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 capsules

Sunitinib Eugia 12.5 mg hard capsules
Hard gelatin capsules of size "4" with a red, opaque cap and a red, opaque body, printed with white ink "S12.5" on the body, containing yellow to orange granules. Approximate capsule size is about 14 mm.

Sunitinib Eugia 25 mg hard capsules
Hard gelatin capsules of size "3" with an olive-green, opaque cap and a red, opaque body, printed with white ink "S25" on the body, containing yellow to orange granules. Approximate capsule size is about 16 mm.

Sunitinib Eugia 50 mg hard capsules
Hard gelatin capsules of size "2" with an olive-green, opaque cap and an olive-green, opaque body, printed with black ink "S50" on the body, containing yellow to orange granules. Approximate capsule size is about 18 mm.

Sunitinib Eugia 12.5 mg, 25 mg, and 50 mg hard capsules are available in blisters, packed 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 also available in HDPE bottles, packed 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: [email protected]

Manufacturer:
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 medicinal product is authorised in 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