SUNITINIB 12.5 mg Twarde kapsułki

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1. Sunitinib Teva 12.5 mg hard capsules, 25 mg hard capsules, 37.5 mg hard capsules, 50 mg hard capsules
   1. What is Sunitinib Teva and what is it 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

Sunitinib Teva 12.5 mg hard capsules, 25 mg hard capsules, 37.5 mg hard capsules, 50 mg hard capsules

sunitinib

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Sunitinib Teva is and what it is used for
• 2. What you need to know before you take 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 is Sunitinib Teva and what is it used for

Sunitinib Teva contains the active substance sunitinib, which is a protein kinase inhibitor. It is
used to treat cancer by preventing the activity of a specific group of proteins
that are known to be involved in the growth and spread 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 intestinal cancer, in cases where imatinib (another anticancer medicine) is no longer effective or can no longer 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 pancreatic cells that produce hormones) with disease progression or are inoperable. If you have any doubts about how Sunitinib Teva works or why it has been prescribed to you, please ask 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
Tell your doctor before taking Sunitinib Teva:

• If you have high blood pressure.Sunitinib Teva can cause an increase in blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Teva and you, if necessary, may need to take medicines to lower your blood pressure.
• If you have or have had blood disorders, bleeding problems or bruising.Treatment with Sunitinib Teva may involve an increased risk of bleeding, changes in the number of some blood cells whose deficiency causes anemia or affects the blood's ability to clot. The risk of bleeding may be greater if you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent the formation of blood clots. Tell your doctor if you experience bleeding while taking Sunitinib Teva.
• If you have heart problems.Sunitinib Teva can cause heart problems. Tell your doctor if you feel very tired, suffer from shortness of breath or have swollen feet and ankles.
• If you experience abnormal changes in heart rhythm.Sunitinib Teva can cause changes in heart rhythm. During treatment with Sunitinib Teva, your doctor may perform an electrocardiogram to assess the extent of these changes. Tell your doctor if, during treatment with Sunitinib Teva, you feel dizzy, faint or have irregular heartbeats.
• If you have recently had problems due to the formation of blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism or thrombosis.Contact your doctor immediatelyif you experience symptoms such as tightness or pain in the chest, pain in the arms, back, neck or jaw/jawbone, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache or dizziness during treatment with Sunitinib Teva.
• If you have or have had an aneurysm (dilation and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have or have had damage to the smaller blood vessels called thrombotic microangiopathy (TMA).Tell your doctor if you notice the appearance of fever, fatigue, tiredness, bruising, bleeding, swelling, mental confusion, loss of vision and convulsions.
• If you have thyroid problems.Sunitinib Teva can cause thyroid problems. Tell your doctor if you become more tired than usual while taking Sunitinib Teva, generally feel colder than other people or your voice becomes lower. Thyroid function should be checked before taking Sunitinib Teva and regularly while you are taking the medicine. If your thyroid does not produce enough thyroid hormone, you may need to take a thyroid hormone replacement.
• If you have or have had problems with the pancreas or gallbladder.Tell your doctor if you experience 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.Tell your doctor if you experience any of the following signs and symptoms of liver problems during treatment with Sunitinib Teva: itching, yellowing of the skin or eyes, dark urine and pain or discomfort in the upper right area of the stomach. Your doctor should perform blood tests to check liver function before and during treatment with Sunitinib Teva, and as clinically appropriate.
• If you have or have had kidney problems.Your doctor will monitor kidney function.
• If you are about to undergo surgery or if you have recently had an operation.Sunitinib Teva can affect how wounds heal. Usually, if you are about to have surgery, you will need to stop treatment with Sunitinib Teva. Your doctor will decide when to start treatment with Sunitinib Teva again.
• It is advisable to have a dental check-up before starting treatment with Sunitinib Teva
• If you have or have had pain in the mouth, teeth and/or jaw/jawbone, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw/jawbone, or tooth loss, tell your doctor and dentist immediately.
• If you need to undergo invasive dental treatment or dental surgery, tell your doctor that you are being treated with Sunitinib Teva, especially if you are also taking bisphosphonates intravenously or have taken them in the past. Bisphosphonates are medicines used to prevent bone complications that may have been prescribed for another clinical problem.
• If you have or have had skin and subcutaneous tissue diseases.During treatment with this medicine, “pyoderma gangrenosum” (painful skin ulceration) or “necrotizing fasciitis” (a skin/soft tissue infection that spreads rapidly and can be fatal) may occur. Contact your doctor immediately if you experience symptoms of infection around a skin wound, including fever, pain, redness, swelling or drainage of pus or blood. This event is generally reversible after discontinuation of sunitinib treatment. Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, which initially appear on the trunk as reddish spots in the shape of a target or circular patches, often with blisters in the center. The reaction can progress to widespread blistering or skin shedding, and can be fatal. If you develop a skin rash or any of these skin symptoms, consult a doctor immediately.
• If you have or have had seizures.Inform your doctor as soon as possible if you have high blood pressure, headache or loss of vision.
• If you have diabetes.Blood sugar levels should be checked regularly in diabetic patients to verify whether the dosage of diabetes medicines needs to be adjusted, in order to minimize the risk of low blood sugar. Inform your doctor as soon as possible if you notice signs and symptoms of reduced blood sugar levels (fatigue, palpitations, sweating, hunger and loss of consciousness).

Children and adolescents
Sunitinib Teva is not indicated for patients under the age of 18 years.

Other medicines and Sunitinib Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those bought without a prescription and herbal medicines.
Some medicines can change the levels of Sunitinib Teva in the body. You should tell your
doctor if you are taking medicines that contain the following active ingredients:

• 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 conditions (such as allergic/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions
• herbal preparations containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety

Sunitinib Tevawith food and drink
Grapefruit juice should be avoided during treatment with Sunitinib Teva.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
If pregnancy is possible, you should use a reliable method of contraception during treatment with Sunitinib Teva.
If you are breastfeeding, tell your doctor. You should not breastfeed during treatment with
Sunitinib Teva.

Driving and using machines
If you feel dizzy or unusually tired, be particularly careful when driving or using
machines.

Sunitinib Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially
“sodium-free”.

3. How to take Sunitinib Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The doctor will prescribe the appropriate dose for you, based on the type of cancer to be treated. If you are being
treated for:

• GIST or mRCC: the usual dose is 50 mg once a day to be taken 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.

The doctor will determine the necessary dose for you and when to stop treatment with Sunitinib Teva.
Sunitinib Teva can be taken with or without food.

If you take more Sunitinib Tevathan you should
If you accidentally took too many capsules, speak to your doctor immediately. Medical intervention may be
necessary.

If you forget to take Sunitinib Teva
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience any of these serious side effects (see also

What you need to know before taking Sunitinib Teva):

Heart problems.Tell your doctor if you feel very tired, short of breath or have swelling in your feet and
ankles. These could be symptoms of heart problems such as heart failure and
problems with the heart muscle (cardiomyopathy).

Lung or breathing problems.Tell your doctor if you experience cough, chest pain,
sudden onset of shortness of breath or coughing up blood. These could be
symptoms of a condition known as pulmonary embolism, which occurs when blood clots
reach the lungs.

Kidney problems.Tell your doctor if you experience altered frequency of urination or no
urine output, which could be symptoms of kidney failure.

Bleeding.Tell your doctor if any of the following symptoms or serious bleeding problems occur during treatment with Sunitinib Teva: swollen, painful stomach (abdomen); vomiting
with blood; dark, tarry stools; blood in your urine; headache or altered mental state; coughing up blood or blood-tinged sputum from the lungs or
airways.

Tumor destruction causing perforation of the intestine.Tell your doctor if you have severe
abdominal pain, fever, nausea, vomiting, blood in your stools or changes in bowel habits.
Other side effects that may occur with Sunitinib Teva are:
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).
• Shortness of breath.
• High blood pressure.
• Excessive tiredness, loss of strength.
• Swelling caused by fluid retention under the skin and around the eyes, deep allergic rash.
• Mouth pain/irritation, sore/inflamed/dry mouth, altered taste, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/distension, loss/decrease of appetite.
• Reduced activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing of the skin/alteration of skin color, excessive skin pigmentation, alteration of hair color, rash on the palms of the hands and soles of the feet, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping. Common: may affect up to 1 in 10 people
• Formation of blood clots in blood vessels.
• Insufficient blood supply to the heart muscle, due to blockage or constriction of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention also around the lungs.
• Infections.
• Complication of serious infections (the infection is present in the bloodstream), which can cause tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Protein in the urine, which sometimes leads to swelling.
• Flu-like syndrome.
• Abnormal blood tests, including levels of liver and pancreatic enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning or painful sensation 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 tearing.
• Altered skin sensation, itching, scaling and inflammation of the skin, blistering, acne, discoloration of nails, hair loss.
• Abnormal sensations in the extremities.
• Excessive reduction/increase in sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Alteration of urine color.
• Depression.
• Chills. Uncommon: may affect up to 1 in 100
• Soft tissue infections, including in the ano-genital region, potentially life-threatening (see section 2).
• Stroke.
• Heart attack caused by an interrupted or reduced blood supply to the heart.
• Alterations in the electrical activity of the heart or altered heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumor destruction causing perforation of the intestine.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• Abnormal communication between two cavities of the body or with the skin.
• Pain in the mouth, teeth and/or jaw/mandible, swelling or irritation in the mouth, numbness or heaviness in the jaw/mandible, or tooth loss. These could be signs and symptoms of bone damage in the jaw/mandible (osteonecrosis), see section 2.
• Overproduction of thyroid hormones with a consequent increase in the amount of energy used by the body at rest.
• Problems with wound healing after surgery.
• Increase of a muscle enzyme in the blood (creatine phosphokinase).
• Exaggerated reaction to allergens, including hay fever, skin rash, itching, hives, localized swelling, and difficulty breathing.
• Inflammation of the colon (colitis, ischemic colitis).

Rare: may affect up to 1 in 1,000

• Severe reactions of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). Tumor lysis syndrome (TLS) - TLS includes a set of metabolic complications that can occur during cancer treatment. They are caused by products of degradation of cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue associated with abnormal laboratory results (elevated levels of potassium, uric acid, and phosphoric acid and low levels of calcium in the blood) that can lead to changes in kidney function and acute renal failure.
• Abnormal breakdown of muscles that can cause kidney problems (rhabdomyolysis).
• Alteration of brain functions that can lead to a variety of symptoms, such as headache, confusion, seizures and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to small blood vessels called thrombotic microangiopathy (TMA).

Not known: frequency cannot be estimated based on available data

• An enlargement or “bulging” of the aorta or a tear in the aortic wall (aortic aneurysms and dissections).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store 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 package, bottle and blister after “EXP”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30 °C. Store in the original package to protect the product from moisture.
• Do not use this medicine if you notice that the package is damaged or shows signs of tampering. Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Teva contains
Sunitinib Teva 12.5 mg hard capsules
The active ingredient is sunitinib. Each capsule contains 12.5 mg of sunitinib.
The other ingredients are:

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

Sunitinib Teva 25 mg hard capsules
The active ingredient is sunitinib. Each capsule contains 25 mg of sunitinib.
The other ingredients are:

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

Sunitinib Teva 37.5 mg hard capsules
The active ingredient is sunitinib. Each capsule contains 37.5 mg of sunitinib.
The other ingredients are:

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

Sunitinib Teva 50 mg hard capsules
The active ingredient is sunitinib. Each capsule contains 50 mg of sunitinib.
The other ingredients are:

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

Description of the appearance of Sunitinib Teva and contents of the pack
Sunitinib Teva 12.5 mg hard capsules
Hard gelatin capsules with opaque orange-medium colored cap and body marked with
black ink with the inscription “12.5” on the cap. Each capsule size 4 (total length
closed approximately 14.2 mm) contains an orange granular powder.
Sunitinib Teva 25 mg hard capsules
Hard gelatin capsules with opaque light orange cap and opaque medium orange body marked with black ink with the inscription “25” on the cap. Each capsule size 3 (total length
closed approximately 15.8 mm) contains an orange granular powder.
Sunitinib Teva 37.5 mg hard capsules
Hard gelatin capsules with opaque bright yellow cap and body marked with
black ink with the inscription “37.5” on the cap. Each capsule size 2 (total length
closed approximately 17.6 mm) contains an orange granular powder.
Sunitinib Teva 50 mg hard capsules
Hard gelatin capsules with opaque light orange cap and body marked with
black ink with the inscription “50” on the cap. Each capsule size 2 (total length closed
approximately 17.6 mm) contains an orange granular powder.
Sunitinib Teva is available in white HDPE bottles of 30 capsules, in blister packs of
28, 30 capsules and unit-dose blister packs containing 28 x 1 and 30 x 1 capsules.
Not all 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, Kraków, 31-546 – Poland
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143 – Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, Zagreb, 10000 – Croatia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Sunitinib Teva 12.5, 25, 37.5, 50 mg Hartkapseln
Belgium Sunitinib Teva 12.5, 25, 37.5, 50 mg harde capsules, gélules, Hartkapseln
Bulgaria Сунитиниб Тева 12,5, 25, 50 mg твърди капсули
Cyprus Sunitinib/Teva 12.5, 25, 37.5, 50 mg σκληρά καψάκια
Croatia Sunitinib Pliva 12.5, 25, 37.5, 50 mg tvrde kapsule
Denmark Sunitinib Teva
Estonia Sunitinib Teva
Finland Sunitinib ratiopharm 12.5, 25, 37.5, 50 mg kapseli, kova
France Sunitinib Teva 12.5, 25, 50 mg, gélule
Germany Sunitinib ratiopharm 12.5, 25, 37.5, 50 mg Hartkapseln
Greece Sunitinib/Teva 12.5, 25, 37.5, 50 mg σκληρά καψάκια
Italy Sunitinib Teva
Latvia Sunitinib Teva 12.5, 50 mg cietās kapsulas
Lithuania Sunitinib Teva 12.5, 50 mg kietosios kapsulės
Luxembourg Sunitinib Teva 12.5, 25, 37.5, 50 mg gélules
Malta Sunitinib Teva 12.5, 25, 50 mg Hard Capsules
Norway Sunitinib Teva
Netherlands Sunitinib Teva 12.5, 25, 37.5, 50 mg, harde capsules
Poland Sunitinib Teva
Portugal Sunitinib Teva
Czech Republic Sunitinib Teva
Slovakia Sunitinib Teva 12.5, 25, 50 mg tvrdé kapsuly
Romania Sunitinib Teva 12.5, 25, 50 mg capsule
Spain Sunitinib Teva 12.5, 25, 50 mg cápsulas duras EFG
Sweden Sunitinib Teva
Slovenia Sunitinib Teva 12.5, 25, 37.5, 50 mg trde kapsule
United Kingdom Sunitinib 12.5 mg Hard Capsules
Hungary Sunitinib Teva 12.5, 25, 37.5, 50 mg kemény kapszula