SUNITINIB VIVANTA 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Sunitinib Vivanta 12.5 mg hard capsules EFG

Sunitinib Vivanta 25 mg hard capsules EFG

Sunitinib Vivanta 37.5 mg hard capsules EFG

Sunitinib Vivanta 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 Vivanta and what is it used for
2. What you need to know before you take Sunitinib Vivanta
3. How to take Sunitinib Vivanta
4. Possible side effects
5. Storage of Sunitinib Vivanta
6. Contents of the pack and further information

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

This medicinal product 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 anticancer 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 Vivanta works or why this medicine has been prescribed for you, ask your doctor.

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

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

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Consult your doctor before starting treatment with Sunitinib Vivanta:

• 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 blood pressure-lowering medicines.

• 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 blood clotting. If you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent blood 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. Consult 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. Consult your doctor if you feel dizzy, weak, 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 the wall of a blood vessel) or tear of the wall of a blood vessel.

• If you have or have had damage to the 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. Contact your doctor if you feel more tired than usual, feel colder than others, or 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 disorders or gallbladder disorders. Contact 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.Contact 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 this medicine. Your doctor will decide when to start taking sunitinib again.

• Before starting treatment with Sunitinib Vivanta, you may be advised to have a dental check-up

• If you have or have had pain in the mouth, teeth, and/or jaw, swelling, or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or a feeling that a tooth is loose, 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 the use of sunitinib, which initially had the appearance of red patches resembling targets or circular patches, often accompanied by central blisters on the trunk. This rash may progress to widespread blisters or peeling of the skin and may be life-threatening. Consult your doctor immediately if you develop a skin rash or the skin symptoms indicated.

• If you have or have had seizures.If you have high blood pressure, headache, or vision loss, notify 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. Inform 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.

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

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 AIDS
• 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 diseases
• herbal medicines containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety

Taking Sunitinib Vivanta with food and drinks

You should avoid taking grapefruit juice while taking sunitinib.

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If you are pregnant or breastfeeding, 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 method of contraception during treatment with sunitinib.

If you are breastfeeding, tell your doctor. You should not breastfeed while taking sunitinib.

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

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

3. How to take Sunitinib Vivanta

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor again.

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 you may need to stop treatment with sunitinib.

Sunitinib Vivanta can be taken with or without food.

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

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

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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 What you need to know before starting to take Sunitinib Vivanta):

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

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

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

Bleeding.Consult 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; having black and tarry stools; urinating with blood; having a headache or a change in your mental state; coughing up blood or bloody sputum from the lungs or airways.

Destruction of the tumor producing a perforation in the intestine.Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in your 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.
• Rapid 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, change in hair color, 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).
• Protein loss in the urine that can cause swelling.
• Pseudogrippal syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High uric acid levels 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), 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, change in nail color, 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.
• Abnormal changes in heart rhythm or electrical activity.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreas inflammation.
• Destruction of the tumor producing 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 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.

All of these can be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.

• Overproduction of thyroid hormones that increase the amount of energy the body consumes at rest.
• Problems with wound healing after surgery.
• High levels of a muscle enzyme (creatine phosphokinase) in the blood.
• Excessive reaction to an allergen, including pollen allergy, 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, darkening of the 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 ulceration (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 in 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 adverse effect, consult your doctor, 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 Vivanta

Keep this medicine out of sight and reach of children.

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

Blister:

Store below 30°C.

Bottle:

Store below 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicines to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sunitinib Vivanta

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg, or 50 mg of sunitinib. The other ingredients are:

• Capsule content: mannitol (E421), croscarmellose sodium, pregelatinized starch (corn), and magnesium stearate.
• Capsule shell: gelatin, purified water, titanium dioxide (E171), red iron oxide (E172) [for 12.5 mg, 25 mg, and 50 mg], black iron oxide (E172) [for 25 mg and 50 mg], yellow iron oxide (E172) [for 25 mg, 37.5 mg, and 50 mg].
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171) [for 12.5 mg, 25 mg, and 50 mg], black iron oxide (E172) [for 37.5 mg].

Appearance of the Product and Package Contents

Sunitinib Vivanta 12.5 mg is supplied in the form of a yellow granular powder in hard gelatin capsules of size "4" (approximately 15 mm) with an orange opaque body printed with a "6" and an orange opaque cap printed with "MS" in white ink.

Sunitinib Vivanta 25 mg is supplied in the form of a yellow granular powder in hard gelatin capsules of size "3" (approximately 16 mm) with an orange opaque body printed with a "7" and a light brown opaque cap printed with "MS" in white ink.

Sunitinib Vivanta 37.5 mg is supplied in the form of a yellow granular powder in hard gelatin capsules of size "3" (approximately 16 mm) with a yellow opaque body printed with an "8" and a yellow opaque cap printed with "MS" in black ink.

Sunitinib Vivanta 50 mg is supplied in the form of a yellow granular powder in hard gelatin capsules of size "2" (approximately 18 mm) with a light brown opaque body printed with a "9" and a light brown opaque cap printed with "MS" in white ink.

It is available in bottles of 28 or 30 capsules and in single-dose blisters that contain 14 x 1, 28 x 1, or 30 x 1 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

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

Local Representative:

Vivanta Generics s.r.o., Spanish branch

C/Guzmán el Bueno, 133, Britannia building

28003 Madrid

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

Portugal Sunitinib Vivanta

Germany Sunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg hard capsules

Spain Sunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg hard capsules EFG

Finland Sunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg hard capsules

Sweden Sunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg hard capsules

Denmark Sunitinib Vivanta

Norway Sunitinib Vivanta

Date of the last revision of this leaflet:May 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/