Sunitinib Teva

Package Leaflet: Information for the User

Sunitinib Teva, 12.5 mg, hard capsules

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

Sunitinib Teva, 50 mg, hard capsules

Sunitinib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Package Leaflet

• 1. What is Sunitinib Teva and what is it used for
• 2. Important information 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 is Sunitinib Teva and what is it used for

Sunitinib Teva contains the active substance sunitinib, which is a protein kinase inhibitor.
Sunitinib Teva is used to treat cancer. It works by blocking the activity of a specific group of proteins that are involved in the growth and spread of cancer cells.
Sunitinib Teva is used to treat the following types of cancer in adults:

• gastrointestinal stromal tumors (GISTs), a type of tumor that occurs in the stomach and intestines, when imatinib (another cancer medicine) is no longer effective 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 (pNETs), tumors that arise from hormone-producing cells in the pancreas, which are progressing and cannot be surgically removed.

If you have any questions about how Sunitinib Teva works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Sunitinib Teva

When not to 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

Before starting treatment with Sunitinib Teva, discuss with your doctor:

• If you have high blood pressure. Sunitinib Teva may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Teva, and you may need to take medicines to lower your blood pressure.
• If you have or have had bleeding or blood disorders. Treatment with Sunitinib Teva may increase the risk of bleeding or changes in the number of certain blood cells, which can cause anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, there may be a higher risk of bleeding. Tell your doctor about any bleeding during treatment with Sunitinib Teva.
• If you have heart problems. Sunitinib Teva may cause heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling in your feet or ankles.
• If you have irregular heart rhythms. Sunitinib Teva may cause irregular heart rhythms. During treatment with Sunitinib Teva, your doctor may perform an electrocardiogram to check for these problems. Tell your doctor if you experience dizziness, fainting, or irregular heart rhythms while taking Sunitinib Teva.
• If you have recently had blood clots in your veins or arteries (including stroke, heart attack, embolism, or thrombosis). You should immediatelycontact your doctor if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, or headache or dizziness.
• 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 or have had damage to the smallest blood vessels called microangiopathic hemolytic anemia. Tell your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems. Sunitinib Teva may cause thyroid problems. Tell your doctor if you feel very tired, are colder than usual, or have a hoarse voice while taking Sunitinib Teva. Your doctor should check your thyroid function before starting treatment with Sunitinib Teva and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take thyroid hormone replacement medicine.
• If you have or have had problems with your pancreas or gallbladder. Tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• If you have or have had liver problems. Tell your doctor if you experience any of the following symptoms of liver problems: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check your liver function before starting treatment with Sunitinib Teva, during treatment, and if you experience any symptoms.
• If you have or have had kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery. Sunitinib Teva may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitinib Teva.
• A dental check-up is recommended before starting treatment with Sunitinib Teva.
• If you experience pain in your mouth, toothache, and/or jaw pain, swelling or ulceration of the mouth, numbness or feeling of heaviness in the jaw, or tooth mobility, you should immediatelyinform your oncologist and dentist;
• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening) may occur. You should immediatelycontact your doctor if you experience symptoms of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after stopping treatment. During treatment with this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches similar to targets or circular patches, often with centrally located blisters. The rash may progress to widespread blisters or peeling of the skin and may be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should immediatelycontact your doctor.
• If you have or have had seizures. Tell your doctor as soon as possible if you experience high blood pressure, headache, or vision loss.
• If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether the dose of the anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you experience symptoms of low blood sugar (tiredness, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Teva is not recommended for patients under 18 years of age.

Sunitinib Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• ketokonazole, itraconazole - used to treat fungal infections;
• erythromycin, clarithromycin, rifampicin - used to treat infections;
• ritonavir - used to treat HIV infections;
• dexamethasone - a corticosteroid used in various diseases (such as allergic disorders and/or 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 disorders.

Sunitinib Teva with food and drink

Do not drink grapefruit juice while taking Sunitinib Teva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitinib Teva.
Women who are breastfeeding should inform their doctor. Do not breastfeed while taking Sunitinib Teva.

Driving and using machines

If you experience dizziness or extreme tiredness, be careful when driving or operating machinery.

Sunitinib Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which is considered to be essentially sodium-free.

3. How to take Sunitinib Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will prescribe the dose that is right for you, depending on the type of cancer. For patients being treated for:

• GIST or MRCC, the usual dose is 50 mg taken once a day for 28 days (4 weeks), followed by a 14-day (2-week) break (without the medicine), in 6-week cycles of treatment.
• pNET, the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the correct dose for you and when to stop taking Sunitinib Teva.
Sunitinib Teva can be taken with or without food.

If you take more Sunitinib Teva than you should

If you have taken too many capsules, contact your doctor immediately.
Medical attention may be necessary.

If you forget to take Sunitinib Teva

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediatelycontact your doctor if you experience any of the following serious side effects (see also Important information before taking Sunitinib Teva):
Heart problems. Tell your doctor if you feel very tired, have shortness of breath, or swelling in your feet and ankles. These may be symptoms of heart problems, including heart failure and heart muscle problems (cardiomyopathy).
Lung or breathing problems. Tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney problems. Tell your doctor if you experience changes in urination frequency or inability to urinate, which may be symptoms of kidney failure.
Bleeding. Tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitinib Teva: stomach pain (abdomen); vomiting blood; black, tarry stools; blood in urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor lysis syndrome leading to intestinal perforation. Tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.
Other side effects of Sunitinib Teva may include:

• very common: may affect more than 1 in 10 people
• reduced number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils)
• shortness of breath
• high blood pressure
• extreme tiredness, loss of strength
• swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep
• mouth pain, mouth ulcers, and/or inflammation, and/or dry mouth, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of appetite and/or decreased appetite
• reduced thyroid activity (hypothyroidism)
• dizziness
• headache
• nosebleeds
• back pain, joint pain
• arm and leg pain
• yellowing of the skin and/or discoloration, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin
• cough
• fever
• sleep disturbances

Common: may affect up to 1 in 10 people

• blood clots in blood vessels
• insufficient blood supply to the heart due to a blockage or narrowing of the coronary arteries
• chest pain
• reduced amount of blood pumped by the heart
• fluid accumulation, including in the lungs
• infections
• complication after severe infection (sepsis), which can lead to tissue damage, organ failure, and death
• low blood sugar (see section 2)
• protein loss in urine, sometimes causing swelling
• flu-like syndrome
• abnormal blood test results, including pancreatic and liver enzymes
• high levels of uric acid in the blood
• hemorrhoids, anal pain, gum bleeding, difficulty swallowing or loss of swallowing ability
• burning or painful sensation in the tongue, inflammation of the mucous membranes, excessive gas in the stomach or intestines
• weight loss
• musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle cramps
• dryness of the nasal mucosa, feeling of nasal congestion
• excessive tearing
• skin sensitivity disorders, itching, skin peeling, and/or inflammation, blisters, acne, nail discoloration, hair loss
• skin sensation disorders
• sensitivity disorders, especially to touch
• heartburn
• dehydration
• hot flashes
• abnormal urine color
• depression
• chills

Uncommon: may affect up to 1 in 100 people

• life-threatening infection of soft tissues, including the perianal and genital area (see section 2)
• stroke
• heart attack caused by interruption or reduction of blood flow to the heart
• changes in the electrical or rhythmic activity of the heart
• fluid accumulation around the heart (pericardial effusion)
• liver failure
• stomach pain (abdomen) caused by pancreatitis
• tumor lysis syndrome leading to intestinal perforation
• inflammation of the gallbladder with or without gallstones
• formation of abnormal connections between one body cavity and another or with the skin
• mouth pain, toothache, and/or jaw pain, swelling or ulceration of the mouth, numbness or feeling of heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2
• excessive production of thyroid hormones leading to increased resting metabolism
• impaired wound healing after surgery
• increased activity of the muscle enzyme (creatine phosphokinase) in the blood
• excessive allergic reaction, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing
• inflammation of the large intestine (colitis, ischemic colitis)

Rare: may affect up to 1 in 1000 people

• severe skin and/or mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• tumor lysis syndrome, a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and can include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, lack of urine clarity, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to kidney damage and acute kidney failure.
• abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis)
• abnormal brain changes, which can cause a syndrome of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome)
• painful skin ulcers (pyoderma gangrenosum)
• liver inflammation
• thyroid gland inflammation
• damage to the smallest blood vessels called microangiopathic hemolytic anemia

Frequency not known (frequency cannot be estimated from the available data)

• enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and arterial dissection).
• lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be signs of a toxic effect of high ammonia levels in the blood on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the representative of the marketing authorization holder.

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 stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of the month.

Do not store above 30°C. Store in the original package to protect from moisture.

• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Teva contains

The active substance is sunitinib. Each hard capsule contains 12.5 mg of sunitinib.
The other ingredients are:
capsule content:mannitol, povidone (K-25), croscarmellose sodium, magnesium stearate.
capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172).
printing ink:shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia, and potassium hydroxide.

Sunitinib Teva, 25 mg, hard capsules

The active substance is sunitinib. Each hard capsule contains 25 mg of sunitinib.
The other ingredients are:
capsule content:mannitol, povidone (K-25), croscarmellose sodium, magnesium stearate.
capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172).
printing ink:shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia, and potassium hydroxide.

Sunitinib Teva, 37.5 mg, hard capsules

The active substance is sunitinib. Each hard capsule contains 37.5 mg of sunitinib.
The other ingredients are:
capsule content:mannitol, povidone (K-25), croscarmellose sodium, magnesium stearate.
capsule shell:gelatin, titanium dioxide (E 171), and iron oxide yellow (E 172).
printing ink:shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia, and potassium hydroxide.

Sunitinib Teva, 50 mg, hard capsules

The active substance is sunitinib. Each hard capsule contains 50 mg of sunitinib.
The other ingredients are:
capsule content:mannitol, povidone (K-25), croscarmellose sodium, magnesium stearate.
capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172).
printing ink:shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia, and potassium hydroxide.

What Sunitinib Teva looks like and contents of the pack

Sunitinib Teva, 12.5 mg, hard capsules
Hard gelatin capsules with an orange opaque cap and an orange opaque body, with black printing "12.5" on the cap. Each capsule, size 4 (approximately 14.2 mm in length), contains orange granules.
Sunitinib Teva, 25 mg, hard capsules
Hard gelatin capsules with a light orange opaque cap and an orange opaque body, with black printing "25" on the cap. Each capsule, size 3 (approximately 15.8 mm in length), contains orange granules.
Sunitinib Teva, 37.5 mg, hard capsules
Hard gelatin capsules with a dark yellow opaque cap and a dark yellow opaque body, with black printing "37.5" on the cap. Each capsule, size 2 (approximately 17.6 mm in length), contains orange granules.
Sunitinib Teva, 50 mg, hard capsules
Hard gelatin capsules with a light orange opaque cap and a light orange opaque body, with black printing "50" on the cap. Each capsule, size 2 (approximately 17.6 mm in length), contains orange granules.
Sunitinib Teva is available in white high-density polyethylene (HDPE) bottles containing 30 capsules, in blisters containing 28 or 30 capsules, and in single-dose blisters containing 28x1 or 30x1 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer/Importer:

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
Zagreb 10000
Croatia
Actavis International Ltd.
4 Sqaq tal-Gidi off Valletta Road,
Luqa LQA 6000,
Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitsa, 2600
Bulgaria