SUNINITIB EUGIA 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Sunitinib Eugia 12.5 mg hard capsules EFG

Sunitinib Eugia 25 mg hard capsules EFG

Sunitinib Eugia 50 mg hard capsules EFG

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 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

1. What is Sunitinib Eugia and what is it used for
2. What you need to know before you take Sunitinib Eugia
3. How to take Sunitinib Eugia
4. Possible side effects
5. Storage of Sunitinib Eugia
6. Contents of the pack 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. It is used to treat cancer and works by preventing the activity of a special group of proteins involved in the growth and proliferation of cancer cells.

Sunitinib is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestine cancer, when imatinib (another anti-cancer medicine) has failed or when imatinib cannot be taken.
• Metastatic renal cell carcinoma (mRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumors (pNET) (tumors of the hormone-producing cells in the pancreas) that have progressed or cannot be removed by surgery.

If you have any questions about how sunitinib works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Sunitinib Eugia

Do not takeSunitinib Eugia

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking sunitinib:

• If you have high blood pressure. Sunitinib may increase blood pressure. Your doctor may check your blood pressure during treatment with sunitinib and, if necessary, treat you with medicines that lower blood pressure.

• If you have or have had blood disorders, bleeding problems, or bruising. Treatment with sunitinib may lead to a high 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, medicines that thin the blood to prevent clots, there may be a higher risk of bleeding. If you experience any bleeding during treatment with sunitinib, consult your doctor.

• If you have heart problems. Sunitinib may cause heart problems. Tell your doctor if you feel very tired, short of breath, or if your feet and ankles are swollen.

• If you have changes in heart rhythm. Sunitinib may cause changes in heart rhythm. Your doctor may perform electrocardiograms to evaluate these problems during treatment with sunitinib. Tell your doctor if you feel dizzy, faint, or have irregular heartbeats during treatment with sunitinib.

• If you have had recent blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if you experience symptoms such as chest pain or pressure, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, speech problems, headache, or dizziness while taking sunitinib.

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

• If you have or have had damage to small blood vessels, known as thrombotic microangiopathy (TMA). Contact your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.

• If you have thyroid problems. Sunitinib may cause thyroid problems. Tell your doctor if you feel more tired than usual, feel colder than others, or if your voice becomes hoarse while taking sunitinib. Before treatment with sunitinib, your thyroid function should be checked and periodically while taking it. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement.

• If you have or have had pancreatic or gallbladder disorders. Tell your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.

• If you have or have had liver problems. Tell your doctor if you develop any of the following signs and symptoms of liver problems during treatment with sunitinib: itching, yellow eyes or skin, dark urine, and pain or discomfort in the upper right stomach area. Your doctor should perform blood tests to monitor liver function before and during treatment with sunitinib, as well as when clinically indicated.

• If you have or have had kidney problems. Your doctor will monitor your kidney function.

• If you are going to have surgery or have had a recent operation. Sunitinib may affect wound healing. If you are going to have an operation, you will usually stop taking sunitinib. Your doctor will decide when to start taking sunitinib again.

• Before starting treatment with sunitinib, you may be advised to have a dental check-up
  • If you have or have had pain in your mouth, teeth, and/or jaw, swelling, or ulcers inside your mouth, tell your doctor and dentist immediately.
  • If you need to have invasive dental treatment or dental surgery, tell your dentist that you are taking sunitinib, especially if you are also being treated with intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may occur due to another medical condition.

• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (rapidly spreading skin/soft tissue infection that can be fatal) may occur. Contact your doctor immediately if you experience symptoms of infection around a skin lesion, such as fever, pain, redness, swelling, or discharge of pus or blood. This reaction is usually reversible after stopping sunitinib. Cases of severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib, which initially had the appearance of target-like spots or circular patches, often accompanied by central blisters on the trunk. This rash may progress to widespread blisters or skin peeling and can be life-threatening. Consult your doctor immediately if you develop a skin rash or the skin symptoms mentioned.

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

• If you have diabetes. Blood glucose levels should be regularly checked in diabetic patients to assess whether it is necessary to adjust the dose of the anti-diabetic medicine to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you experience signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

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

Other medicines and Sunitinib Eugia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal medicines.

Some medicines may affect the levels of sunitinib in your body. You should tell your doctor if you are taking medicines that contain 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 for various diseases (such as allergic/respiratory disorders or skin diseases).
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological disorders.
• herbal medicines containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety.

Taking Sunitinib Eugia with food and drinks

You should avoid taking grapefruit juice while taking sunitinib.

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.

If you can become pregnant, you should use a reliable contraceptive method during treatment with sunitinib.

If you are breast-feeding, tell your doctor. You should not breast-feed while taking sunitinib.

Driving and using machines

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

Sunitinib Eugia contains sodium

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

3. How to take Sunitinib Eugia

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Your doctor will determine the correct dose for you depending on the type of cancer being treated. If you are going to receive treatment for:

• GIST or mRCC: the usual dose is 50 mg once a day for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (without medication) in 6-week cycles.
• pNET: the usual dose is 37.5 mg once a day without a rest period.

Your doctor will tell you the dose you need to take and when to stop treatment with sunitinib.

This medicine can be taken with or without food.

If you take more Sunitinib Eugia than you should

If you have accidentally taken too many capsules, tell your doctor immediately. You may need medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sunitinib Eugia

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should contact your doctor immediately if you experience any of these serious adverse effects (see also Whatyou need to know before takingSunitinib Eugia):

Heart problems.Inform your doctor if you feel very tired, are short of breath, or if your feet and ankles are swollen. These may be symptoms of heart problems that can include heart failure and muscle heart problems (cardiomyopathy).

Lung or respiratory problems.Inform your doctor if you develop a cough, chest pain, sudden breathing difficulties, or cough up blood. These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to the lungs.

Kidney problems.Inform your doctor if you experience a change in the frequency or absence of urination, as these may be symptoms of kidney failure.

Bleeding.Inform your doctor if you have any of these symptoms or a serious bleeding problem during treatment with sunitinib: painful or swollen stomach (abdomen); vomiting blood; black, tarry stools; blood in the urine; headache or changes in mental state; coughing up blood or bloody sputum from the lungs or airways.

Destruction of the tumor producing a perforation in the intestine.Inform your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.

Other adverse effects with sunitinib may include:

Very common: may affect more than 1 in 10 people

• Reduction in the number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Difficulty breathing.
• High blood pressure.
• Extreme fatigue, loss of strength.
• Swelling of tissues caused by fluids under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth ulcers/inflammation/dryness, taste disorders, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/decreased appetite.
• Decreased activity of the thyroid gland (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 the palms of the hands and soles of the feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Lack of blood flow to the heart muscle due to obstruction or constriction of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complication of a severe infection (infection is present in the bloodstream) that can cause tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Loss of protein in the urine that can cause swelling.
• Pseudogrippal syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, rectal pain, gum bleeding, difficulty swallowing, or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the digestive tract lining, excess gas in the stomach or intestine.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Nasal dryness, nasal congestion.
• Excessive tear production.
• Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, nail color changes, hair loss.
• Abnormal sensation in the limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially life-threatening soft tissue infection, including the anogenital region (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.
• Changes in the electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreas inflammation.
• Destruction of the tumor that produces a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal tube-like structure from a normal body cavity to another body cavity or to the skin.
• Pain in the mouth, teeth, and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or feeling that a tooth is loose. These may be signs and symptoms of jawbone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones that increase the amount of energy the body uses at rest.
• Problems with wound healing after surgery.
• High levels of an enzyme (creatine phosphokinase) in the muscle.
• Excessive reaction to an allergen, including allergy to pollen, skin rash, itching, hives, swelling of body parts, and difficulty breathing.
• Inflammation of the colon (colitis, ischemic colitis).

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

• Severe skin and/or mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS) - TLS encompasses a series of metabolic complications that can occur during cancer treatment. These complications are caused by products released by 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) that can lead to changes in kidney function and acute kidney failure.
• Abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a range of symptoms, including headache, confusion, seizures, and loss of vision (posterior reversible leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damaged small blood vessels known as thrombotic microangiopathy (TMA).

Frequency not known (cannot be estimated from available data)

• Increased and weakened blood vessel wall or tear of the blood vessel wall (aneurysms and arterial dissections).
• Lack of energy, confusion, drowsiness, loss of consciousness/coma: these symptoms can be signs of brain toxicity caused by high levels of ammonia in the blood (hyperammonemic encephalopathy).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online system: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sunitinib Eugia

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton, bottle, and blister, after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

Do not use this medicine if you notice that the packaging is damaged or shows signs of having been opened.

6. Package Contents and Additional Information

Composition ofSunitinib Eugia

• The active ingredient 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, sodium croscarmellose, povidone, and magnesium stearate.

Capsule shell: titanium dioxide (E171), yellow iron oxide (E172) (only for 25 mg and 50 mg), red iron oxide (E172), indigo carmine (E132) (only for 25 mg and 50 mg), and gelatin.

Printing ink:lacquer (E904), titanium dioxide (E171) (only for 12.5 mg and 25 mg), black iron oxide (E172) (only for 50 mg), potassium hydroxide (E525).

Appearance of the Product and Package Contents

Sunitinib Eugia 12.5 mg hard capsules EFG

Hard gelatin capsule of size "4", with the cap opaque red and the body opaque red, with "S12.5" printed on the body in white ink, filled with yellow to orange granules. The approximate size of the capsule is 14 mm.

Sunitinib Eugia 25 mg hard capsules EFG

Hard gelatin capsule of size "3", with the cap opaque olive green and the body opaque red, with "S25" printed on the body in white ink, filled with yellow to orange granules. The approximate size of the capsule is 16 mm.

Sunitinib Eugia 50 mg hard capsules EFG

Hard gelatin capsule of size "2", with the cap opaque olive green and the body opaque olive green, with "S50" printed on the body in white ink, filled with yellow to orange granules. The approximate size of the capsule is 18 mm.

Sunitinib Eugia hard capsules are available in blister packs with pack sizes of 28, 30, 50, 56, 60, 70, 84, 90, 98, 100, 110, and 120 hard capsules.

Sunitinib Eugia hard capsules are available in HDPE bottles with a pack size of 28 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Germany: Sunitinib PUREN 12.5 mg/25 mg/50 mg hard capsules

Spain: Sunitinib Eugia 12.5 mg hard capsules EFG

Sunitinib Eugia 25 mg hard capsules EFG

Sunitinib Eugia 50 mg hard capsules EFG

France: SUNITINIB ARROW 12.5 mg/25 mg/50 mg, capsules

Netherlands: Sunitinib Eugia 12.5 mg/25 mg/50 mg, hard capsules

Poland: Suntinib Aurovitas

Portugal: Sunitinib Generis

Sweden: Sunitinib Eugia 12.5 mg/25 mg/37.5 mg/50 mg hard capsules

Date of the last revision of this leaflet: December 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).