Sunitinib Teva 50 mg hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the user

Sunitinib Teva 50 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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. How to store 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 spread 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 failed or cannot be used.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Progressive, unresectable or metastatic pancreatic neuroendocrine tumours (pNET) (tumours of the 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 taking Sunitinib Teva

Do not take Sunitinib Teva:

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

Warnings and precautions

Talk to your doctor before starting treatment with 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 an increased risk of bleeding or cause changes in the number of certain blood cells, which can result in anemia or affect blood clotting ability. 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-related issues. 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. Contact 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 aortic aneurysm.

• If you have previously experienced an episode of tearing in the wall of the aorta known as aortic dissection.

• If you currently have or have previously 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, or seizures.

• If you have thyroid gland problems. Sunitinib Teva may cause thyroid-related issues. Contact your doctor if you feel unusually tired, feel colder than usual, or your voice becomes deeper while taking Sunitinib Teva. Thyroid function should be checked 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 replacement thyroid hormone.

• 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 or 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 abdomen. 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 surgery. Sunitinib Teva may affect wound healing. If you are undergoing surgery, you will generally need to stop taking Sunitinib Teva. Your doctor will decide when you can resume treatment.

• 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 your mouth, teeth, and/or jaw, swelling or sores in your mouth, numbness or a heavy sensation in the jaw, or loose teeth, inform your doctor and dentist immediately.
  2. • If you require invasive dental treatment or dental surgery, inform your dentist that you are being treated with Sunitinib Teva, especially if you are also receiving or have previously received 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 skin and subcutaneous tissue disorders. During treatment with this medicine, you may develop "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be fatal). 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 upon discontinuation of sunitinib. Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use. These initially appear as red, target-like spots or circular patches, often with central blisters, typically on the trunk. The rash may progress to widespread blistering or skin peeling and can be life-threatening. Consult your doctor immediately if you develop a skin rash or any of 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 monitored regularly to determine whether adjustment of antidiabetic medication is needed, minimizing 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

The use of Sunitinib Teva is not recommended in patients under 18 years of age.

Other medicines and Sunitinib Teva

Inform 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 remedies containing St. John’s wort (Hypericum perforatum) – used for the treatment of depression and anxiety

Taking Sunitinib Teva with food and drinks

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 must use a reliable method of contraception during treatment with Sunitinib Teva.

If you are breastfeeding, inform your doctor. You must not breastfeed while being treated 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 for using this medicine as 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 to be treated. If you are receiving treatment 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 (without medication), in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily without a rest period.

Your doctor will advise you on the appropriate dose you need to take, as well as whether you need to interrupt treatment with Sunitinib Teva and when.

Sunitinib Teva may 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 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 can cause adverse effects, although not everyone experiences them.

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

Lung or breathing problems. Contact your doctor if you develop cough, chest pain, sudden 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. Contact your doctor if you experience changes in the frequency or absence of urination, as these may be symptoms of kidney failure.

Bleeding. Contact your doctor if you experience any of these symptoms or have 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 causing a perforation in the intestine. Contact 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

• Decrease 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 due to fluid under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, sores/inflammation/dryness in the mouth, taste disturbances, stomach discomfort, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin colour changes, excessive skin pigmentation, hair colour changes, 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 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 serious 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.
• Pseudoflu-like syndrome.
• Abnormal blood tests, including pancreatic and liver enzymes.
• High level of uric acid in blood.
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning or painful sensation on the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tear production.
• Abnormal skin sensation, itching, scaly and inflamed skin, blisters, acne, nail colour changes, hair loss.
• Abnormal sensation 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 ano-genital 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 causing a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal passage or tract from one normal body cavity to another body cavity 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.

All of 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).
• Severe allergic reaction, including pollen allergy, skin rash, skin itching, hives, swelling of body parts, and breathing difficulties.
• 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 levels of calcium 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 that 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 (arterial aneurysms and 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 stated on the outer packaging, bottle, and blister pack, after EXP or CAD. The expiry date refers to the last day of the month indicated.
• Do not store above 30 °C. Keep in the original container to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of having been opened.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sunitinib Teva

Sunitinib Teva 50 mg hard capsules

The active substance is sunitinib. Each capsule contains 50 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 container

Sunitinib Teva 50 mg hard capsules

Hard gelatin capsules with a light orange opaque cap and a light orange opaque body, with "50" printed in black ink on the cap. Each size 2 capsule (approximately 17.6 mm in total length when closed) contains 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 or 30x1 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Authorization 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/)