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 this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

This medication contains the active ingredient sunitinib, which is a protein-tyrosine kinase inhibitor. It is used for the treatment of cancer and acts by preventing the activity of a specific 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 intestinal cancer, when imatinib (another anticancer medication) has failed or 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 hormone-secreting cells in the pancreas) that have progressed or cannot be removed with surgery.

If you have any doubts about how Sunitinib Vivanta works or why this medication has been prescribed for you, consult your doctor.

Do not take Sunitinib Vivanta

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

Warnings and precautions

Consult your doctor before starting to take Sunitinib Vivanta:

• If you have high blood pressure.Sunitinib may increase blood pressure. Your doctor may monitor your blood pressure during treatment with sunitinib, and if necessary, you may be treated with medicines that reduce 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 produce changes in the number of certain blood cells, which may cause anemia or affect blood clotting. If you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent clots, there may be a greater 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 have swollen feet and ankles.

• If you have abnormal heart rhythm.Sunitinib may cause abnormalities in heart rhythm. Your doctor may obtain electrocardiograms to evaluate these problems during treatment with sunitinib. Consult your doctor if during treatment with sunitinib you feel dizzy, weak or have abnormal heartbeats.

• 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, pain in the arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of the body, speech problems, headache or dizziness while on treatment with sunitinib.

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

• If you have or have had damage to the smaller blood vessels known as microangiopathic thrombosis (MAT).Contact your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, loss of vision and convulsions.

• If you have thyroid problems.Sunitinib may cause thyroid problems. Contact your doctor if you feel tired more easily, are usually colder than others or your voice becomes deeper while taking sunitinib. Before starting treatment with sunitinib, your thyroid function should be checked and monitored 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 problems.Contact your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdominal area), 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 abdominal 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 renal function.

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

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

• If you have or have had mouth pain, tooth or gum problems, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or if you feel 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, particularly if you are also taking or have been treated with bisphosphonates by intravenous administration. 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, you may develop "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (infection of the skin/soft tissues that spreads quickly and can be fatal). Contact your doctor immediately if you experience symptoms of infection around a skin lesion, such as fever, pain, redness, swelling or pus or blood discharge. This reaction is usually reversible after stopping sunitinib. Cases of severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported, associated with the use of sunitinib, which initially appeared as red spots resembling targets or circular spots, often accompanied by central blisters on the trunk. This rash may progress to form widespread blisters or cause skin peeling, and may be life-threatening. Consult your doctor immediately if you develop a skin rash or the indicated skin symptoms.

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

• If you have diabetes.Your blood glucose levels should be checked regularly, in order to assess whether it is necessary to adjust the dose of antidiabetic medication 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 patients under 18 years of age.

Other medicines and Sunitinib Vivanta

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those purchased without a prescription.

Some medicines may affect the levels of sunitinib in your body. You should inform your doctor if you are taking medicines that contain any of the following active ingredients:

• ketoconazole, itraconazole – used to treat fungal infections
• erythromycin, clarithromycin, rifampicin – used to treat infections
• ritonavir – used to treat HIV/AIDS
• dexamethasone – a corticosteroid used to treat various diseases (such as allergic/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological disorders
• herbal remedies containing St. John's Wort or hypericum (Hypericum perforatum)– used to treat depression and anxiety

Taking Sunitinib Vivanta with food and drinks

You should avoid taking grapefruit juice while on treatment with sunitinib.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

If you are breastfeeding, inform your doctor. You should not breastfeed your child during treatment with sunitinib.

Driving and operating machinery

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

Sunitinib Vivanta contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will establish the correct dose for you depending on the type of cancer being treated.

If you are to receive treatment for:

• GIST or CCRM: the usual dose is 50 mg once a day for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medication) in 6-week cycles.
• pNET: the usual dose is 37.5 mg once a day without a rest period.

Your doctor will indicate the suitable dose you need to take, as well as whether you need to suspend treatment with sunitinib and when.

Sunitinib Vivanta can be taken with or without food.

Taking More Sunitinib Vivanta than You Should

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

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

Taking Sunitinib Vivanta When You Forget

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should contact your doctor immediately if you experience any of the following serious side effects (see alsoWhat you need to know before starting to take Sunitinib Vivanta):

Heart problems.Consult your doctor if you are very tired, short of breath, or have swollen feet and ankles. These 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 difficulty breathing, 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.Consult your doctor if you experience a change in urination frequency or absence of urination, as these may be symptoms of kidney failure.

Bleeding.Consult your doctor if you have any of these symptoms or a severe bleeding problem during treatment with sunitinib: stomach (abdomen) pain or swelling; vomit blood; have black, sticky stools; urinate blood; have a headache or any change in mental status; cough up blood or have bloody sputum from the lungs or respiratory tract.

Tumor destruction causing a perforation in the intestine.Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other side 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.
• Fast swelling of tissues caused by fluid under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach problems, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased thyroid gland activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleed.
• Back pain, joint pain.
• Arm and leg pain.
• Yellow skin/skin discoloration, skin hyperpigmentation, hair color change, skin rash on palms of hands and soles of feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Reduced blood flow to the heart muscle due to coronary artery obstruction or constriction.
• Chest pain.
• Decreased heart pumping ability.
• Fluid retention including around the lungs.
• Infections.
• Severe infection complication (infection present in the bloodstream) that can cause tissue damage, organ failure, and death.
• Low blood sugar (see section 2).
• Protein loss in urine that can cause swelling.
• Pseudogripal syndrome.
• Abnormal blood test results including pancreatic and liver enzymes.
• High uric acid levels in blood.
• Hemorrhoids, rectal pain, gingival bleeding, difficulty swallowing or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.
• Runny nose, nasal congestion.
• Excessive tear production.
• Abnormal skin sensation, itching, scaly and inflamed skin, blisters, acne, nail color change, hair loss.
• Abnormal sensation in extremities.
• Abnormally decreased/increased sensitivity, especially to touch.
• Stomach burning.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

• Potentially fatal soft tissue infection, including the anogenital region (see section 2).
• Cerebrovascular accident.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.
• Abnormal heart rhythm or arrhythmia.
• Fluid around the heart (pericardial effusion).
• Liver insufficiency.
• Abdominal pain caused by pancreatitis inflammation.
• Tumor destruction causing a perforation in the intestine.
• Bile duct inflammation, associated or not with gallstones.
• Abnormal tube formation as if it were a conduit from a normal body cavity to another body cavity or to the skin.
• Mouth, tooth, and/or maxillary pain, swelling, or sores inside the mouth, numbness or a feeling of heaviness in the maxilla, or feeling like a tooth is loose.

These may be signs and symptoms of jaw bone damage (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.
• Elevated blood levels of a muscle enzyme (creatine phosphokinase).
• Excessive reaction to an allergen, including pollen allergy, skin rash, itching, urticaria, swelling of body parts, and difficulty breathing.
• 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 includes a series of metabolic complications that can occur during cancer treatment. These complications are caused by products released by dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, dark urine, and fatigue, associated with abnormal laboratory test results (high potassium, uric acid, and phosphorus levels, and low calcium levels in blood) that can lead to kidney function changes and acute kidney failure.
• Abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a series of symptoms including headache, confusion, seizures, and vision loss (posterior reversible encephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damage to small blood vessels known as microangiopathic thrombosis (MAT).

Unknown frequency (cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSSpanish Medicines Adverse Reaction Reporting System:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, bottle, and blister pack after CAD. The expiration date is the last day of the month indicated.

Blister pack:

Store below 30°C.

Bottle:

Store below 25°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Sunitinib Vivanta Composition

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

• Capsule Content: mannitol (E421), croscarmelose sodium, pregelatinized cornstarch and magnesium stearate.
• Capsule Coating: gelatin, purified water, titanium dioxide (E171), iron oxide red (E172) [for 12.5 mg, 25 mg and 50 mg], iron oxide black (E172) [for 25 mg and 50 mg], iron oxide yellow (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], iron oxide black (E172) [for 37.5 mg].

Product Appearance and Packaging Contents

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

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

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

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

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Responsible Person

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

For more information about this medication, please contact the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

PortugalSunitinib Vivanta

GermanySunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg Hard Capsules

SpainSunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg hard capsules EFG

FinlandSunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg kovatkapselit

SwedenSunitinib Vivanta 12.5 mg/25 mg/37.5 mg/50 mg hårdakapslar

DenmarkSunitinib Vivanta

NorwaySunitinib Vivanta

Last review date of thisleaflet:May 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/