Prospecto:Information for the User

Sunitinib Teva 12.5 mg Hard Capsules EFG

Read this entire prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Sunitinib Teva

3.How to take Sunitinib Teva

4.Possible adverse effects

5Storage of Sunitinib Teva

6.Contents of the package and additional information

Sunitinib Teva contains the active ingredient sunitinib, which is a protein-kinase inhibitor. It is used for the treatment of cancer and acts by preventing the activity of a special group of proteins involved in the growth and proliferation of cancer cells.

Sunitinib Teva 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 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 Teva works or why this medication has been prescribed for you, consult your doctor.

Do not take Sunitinib Teva:

• 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 Teva:

• If you have high blood pressure Sunitinib Teva may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Teva, 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 Teva 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 Teva, consult your doctor.

• If you have heart problems Sunitinib Teva 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 abnormal heart rhythm changes Sunitinib Teva may cause abnormal heart rhythm changes. Your doctor may obtain electrocardiograms to evaluate these problems during treatment with Sunitinib Teva. Consult your doctor if you experience dizziness, fainting, or abnormal heartbeats during treatment with Sunitinib Teva.

• If you have had recent blood clots in veins and/or arteries (types of blood vessels), including stroke, myocardial infarction (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 Teva.

• 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 been diagnosed with an enlargement or "bulging" of the aorta known as an aortic aneurysm.

• If you have experienced a previous episode of a tear in the wall of the aorta known as aortic dissection.

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

• If you have thyroid problems Sunitinib Teva may cause thyroid problems. Contact your doctor if you feel tired more easily, are generally colder than others, or if your voice becomes deeper while taking Sunitinib Teva. Before starting treatment with Sunitinib Teva and periodically while taking it, your thyroid function should be monitored. If your thyroid gland does not secrete 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 Teva: 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 Teva, as well as when clinically indicated.

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

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

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

• 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 and 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, 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 Contact your doctor as soon as possible if you experience high blood pressure, headache, or vision loss.

• If you have diabetes Your blood glucose levels should be regularly checked to evaluate if you need to adjust your 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 Teva is not recommended for use in patients under 18 years of age.

Other medicines and Sunitinib Teva

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 Teva 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
• 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 medicines containing St. John's Wort or hypericum ( Hypericum perforatum ) – used to treat depression and anxiety

Taking Sunitinib Teva with food and drinks

You should avoid taking grapefruit juice while on treatment with Sunitinib Teva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you 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 Teva.

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

Driving and operating machinery

If you experience dizziness or unusual fatigue, you should exercise special caution when driving or operating machinery.

Sunitinib Teva contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) 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 appropriate dose you need to take, as well as whether you need to suspend Sunitinib Teva treatment and when.

Sunitinib Teva can be taken with or without food.

If you take more Sunitinib Teva 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested.

If you forgot to take Sunitinib Teva

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 also What you need to know before starting to take Sunitinib Teva):

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 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. Consult your doctor if you experience a change in the 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 Teva: stomach (abdomen) pain or swelling, vomit blood, have black and sticky stools, urinate blood, have a headache or any change in your mental state, cough up blood or have bloody sputum from the lungs or airways.

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

Other side effects with Sunitinib Teva 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 tiredness, loss of strength.
• Swelling of tissues caused by fluid under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth ulcers/inflammation/dryness, taste disturbances, stomach problems, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/disappearance of appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/color changes in the skin, excessive skin pigmentation, hair color change, skin rash on the palms of the hands and soles of the 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 blockage or constriction of coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complication of a severe infection (the infection is 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.
• Pharyngitis.
• 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), muscle 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 the extremities.
• Abnormally decreased/increased sensitivity, especially to touch.
• Stomach burning.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially fatal soft tissue infection, including the anogenital region (see section 2).
• Cerebrovascular accident
• Myocardial infarction (heart attack) caused by interruption or reduction of blood flow to the heart.
• Abnormal heart rhythm or arrhythmia.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• 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 jaw pain, swelling, or ulcers inside the mouth, numbness, or a feeling of heaviness in the jaw, or the feeling that a tooth is loose. All of these may be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.

• Excessive production 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, 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 the products released by dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue, associated with abnormal laboratory test results (high potassium, uric acid, and phosphate levels, and low calcium levels in the 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 range of symptoms including headache, confusion, seizures, and vision loss (posterior reversible encephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum)
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damage to the smallest blood vessels known as microangiopathic thrombosis (MAT).

Frequency not known (cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.
• Do not use this medicationafter the expiration date that appears on the outer packaging and the bottle and blister pack after CAD or EXP. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30 °C. Store in the original packaging to protect it from moisture.
• Do not usethis medicationif 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.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Sunitinib Teva Composition

Sunitinib Teva 12.5 mg Hard Capsules

The active ingredient is sunitinib. Each capsule contains 12.5 mg of sunitinib.

The other components are:

• Capule Content: mannitol, povidone K-25, croscarmellose sodium, magnesium stearate.
• Capule Coating: gelatin, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172)
• Printing Ink: shellac, iron oxide black (E172), propylene glycol, concentrated ammonia solution and potassium hydroxide.

Product Appearance and Packaging Contents

Sunitinib Teva 12.5 mg Hard Capsules

Hard gelatin capsules with opaque orange cap and opaque orange body, with "12.5" printed in black ink on the cap. Each capsule size 4 (the closed length is approximately 14.2 mm) contains a yellowish orange powder.

Sunitinib Teva is available in white HDPE bottles of 30 capsules, in blister packs of 28, 30 capsules and in single-dose blisters containing 28x1 and 30x1 capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Responsible Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Wuerttemberg

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

or

Actavis International Ltd.

4 Sqaq tal-Gidi off Valletta Road,

Luqa LQA 6000,

Malta

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa, 2600

Bulgaria

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

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Last review date of thisleaflet:November 2019

The detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)