Sunitinib Teva 12.5 mg hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Sunitinib Teva 12.5 mg hard capsules EFG

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It could harm them.

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

Leaflet Contents

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

2. What you need to know before taking Sunitinib Teva

3. How to take Sunitinib Teva

4. Possible side effects

5. Storage of Sunitinib Teva

6. Contents of the pack and other information

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

Sunitinib Teva contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer and works by blocking the activity of a specific 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 tumour (GIST), a type of cancer of the stomach and intestine, when imatinib (another anticancer medicine) has already failed or cannot be used.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumours (pNET) (tumours of hormone-secreting cells in the pancreas) that have progressed or cannot be surgically removed.

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

2. What you need to know before starting Sunitinib Teva

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

Talk to your doctor before starting Sunitinib Teva:

• If you have high blood pressure. Sunitinib Teva can increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Teva, and if necessary, you may be treated with medications that lower 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 cause changes in the number of certain blood cells, which may result in anaemia or affect the blood’s ability to clot. If you are taking warfarin or acenocoumarol, medications that thin the blood to prevent clots, there may be an increased 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, become short of breath, or have swollen feet or ankles.

• If you have abnormal changes in your heart rhythm. Sunitinib Teva may cause irregularities in heart rhythm. Your doctor may perform electrocardiograms (ECGs) to assess these issues during treatment with Sunitinib Teva. Consult your doctor if, during treatment with Sunitinib Teva, you feel dizzy, faint, or experience abnormal heartbeats.

• If you have recently had 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, arm, back, neck or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache or dizziness while being treated with Sunitinib Teva.

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

• If you have been diagnosed with enlargement or “bulging” of the aorta known as an aortic aneurysm.

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

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

• If you have thyroid gland problems. Sunitinib Teva may cause thyroid gland problems. Contact your doctor if you feel unusually tired, feel cold more often than others, or your voice becomes deeper while taking Sunitinib Teva. Thyroid function should be monitored before starting treatment with Sunitinib Teva and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement therapy.

• 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 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 Teva: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to monitor liver function before and during treatment with Sunitinib Teva, as well as whenever clinically indicated.

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

• If you are scheduled for surgery or have recently undergone an operation. Sunitinib Teva may affect wound healing. If you are due to have surgery, you will generally stop taking Sunitinib Teva. Your doctor will decide when to restart treatment with Sunitinib Teva.

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

1. • if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or if your teeth become loose, tell your doctor and dentist immediately.
2. • if you need invasive dental treatment or dental surgery, inform your dentist that you are being treated with Sunitinib Teva, especially if you are also being treated or have been treated with intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone complications that may have been administered for another medical condition.

• If you have or have had disorders of the skin and subcutaneous tissue. During treatment with this medicine, "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be life-threatening) may occur. Contact your doctor immediately if you notice signs of infection around a skin lesion, such as fever, pain, redness, swelling, or pus or blood discharge. This reaction is generally reversible after discontinuation of sunitinib. Serious skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use, initially appearing as reddish spots resembling targets or circular lesions, often accompanied by central blisters, typically on the trunk. This rash may progress to widespread blistering or skin peeling and may be life-threatening. Consult your doctor immediately if you develop a skin rash or the described skin symptoms.

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

• If you have diabetes. Blood glucose levels in diabetic patients should be checked regularly to assess whether adjustment of antidiabetic medication is needed, 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, or loss of consciousness).

Children and adolescents

Sunitinib Teva is not recommended for use in individuals under 18 years of age.

Other medicines and Sunitinib Teva

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

Some medicines may affect the levels of Sunitinib Teva in your body. You must 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
• dexamethasone – a corticosteroid used for various conditions (such as allergic/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 for the treatment of depression and anxiety

Taking Sunitinib Teva with food and drink

You should avoid drinking grapefruit juice while being treated with Sunitinib Teva.

Pregnancy and breastfeeding

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

If you are able to become pregnant, you should use a reliable method of contraception during treatment with Sunitinib Teva.

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

Driving and using machines

If you experience dizziness or unusual tiredness, take special care when driving or operating machinery.

Sunitinib Teva contains Sodium

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

3. How to take Sunitinib Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

Your doctor will determine the correct dose for you depending on the type of cancer being treated. If you are 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) rest period (no medication), in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily without a rest period.

Your doctor will tell you the appropriate dose you need to take, as well as whether you need to interrupt treatment with Sunitinib Teva 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, contact your doctor immediately. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Sunitinib Teva

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

You should contact your doctor immediately if you experience any of the following serious adverse effects (see also What you need to know before starting to take Sunitinib Teva):

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

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

Kidney problems. Consult your doctor if you experience changes 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 experience a serious bleeding problem during treatment with Sunitinib Teva: painful or swollen stomach (abdomen), vomiting blood, black and tarry stools, blood in urine, headache, changes in mental status, coughing up blood or bloody sputum from the lungs or airways.

Tumour destruction leading to intestinal perforation. Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other adverse 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.
• Tissue swelling due to fluid accumulation under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach discomfort, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased thyroid gland activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin colour changes, excessive skin pigmentation, hair colour changes, rash on the palms of the hands and soles of the feet, skin 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 narrowing of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complication of a severe infection (infection present in the bloodstream) that may cause tissue damage, organ failure, and death.
• Low blood sugar level (see section 2). Loss of protein in urine which may cause swelling.
• Pseudoinfluenza syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High blood uric acid level.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tear production.
• Abnormal skin sensations, itching, scaly and inflamed skin, blisters, acne, nail colour changes, hair loss.
• Abnormal sensations in the limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Indigestion.
• Dehydration.
• Hot flushes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially life-threatening soft tissue infection, including in the anogenital region (see section 2).

• Stroke.

• Myocardial infarction (heart attack) caused by interruption or reduction of blood flow to the heart.

• Changes in the heart's electrical activity or abnormal heart rhythm.

• Fluid around the heart (pericardial effusion).

• Liver failure.

• Stomach (abdominal) pain caused by inflammation of the pancreas.

• Tumour destruction leading to a hole in the intestine (perforation).

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

• Abnormal tube-like connection from one body cavity to another or to the skin.

• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loose teeth. These may be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.

• Overproduction of thyroid hormones increasing the body's resting energy consumption.

• 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, skin itching, hives, swelling of body parts, and difficulty breathing.

• Inflammation of the colon (colitis, ischaemic 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).
• Tumour lysis syndrome (TLS) – TLS includes a series of metabolic complications that may occur during cancer treatment. These complications are caused by substances released from 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 levels of potassium, uric acid and phosphorus, and low calcium levels in blood) which may lead to changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscles which may lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain which may cause a range of symptoms including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sunitinib Teva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the outer packaging, bottle, and blister after CAD or EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30 °C. Keep in the original packaging to protect from moisture.
• Do not use this medicine if the packaging is damaged or shows signs of having been opened.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sunitinib Teva

Sunitinib Teva 12.5 mg hard capsules

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

The other components are:

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

Appearance of the product and contents of the pack

Sunitinib Teva 12.5 mg hard capsules

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas (Madrid)
Spain

Date of the most recent revision of this leaflet: November 2019

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