Sunitinib Sinthon

Leaflet accompanying the packaging: information for the user

Sunitinib Synthon, 12.5 mg, hard capsules

Sunitinib Synthon, 25 mg, hard capsules

Sunitinib Synthon, 50 mg, hard capsules

Sunitinib

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Sunitinib Synthon and what is it used for
• 2. Important information before taking Sunitinib Synthon
• 3. How to take Sunitinib Synthon
• 4. Possible side effects
• 5. How to store Sunitinib Synthon
• 6. Contents of the pack and other information

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

Sunitinib Synthon contains the active substance sunitinib, which is a protein kinase inhibitor. Sunitinib Synthon is used to treat cancer. It inhibits the activity of a specific group of proteins known to be involved in the growth and spread of cancer cells.
Sunitinib Synthon is used to treat the following types of cancer in adults:

• gastrointestinal stromal tumors (GIST), a type of stomach and intestine cancer, when imatinib (another anticancer drug) has stopped working or the patient cannot take it;
• metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• pancreatic neuroendocrine tumors (pNET) (tumors that arise from hormone-producing cells in the pancreas) that are progressing or cannot be surgically removed.

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

2. Important information before taking Sunitinib Synthon

When not to take Sunitinib Synthon

• If the patient is allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Sunitinib Synthon, discuss the following with your doctor:

• If you have high blood pressure. Sunitinib Synthon may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Synthon, and you may need to be treated with blood pressure-lowering medicines.
• If you have or have had blood disorders, bleeding, or bruising. Treatment with Sunitinib Synthon may increase the risk of bleeding or change 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 Synthon.
• If you have heart problems. Sunitinib Synthon may cause heart problems. Tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If you have arrhythmias. Sunitinib Synthon may cause abnormal heart rhythms. During treatment with Sunitinib Synthon, your doctor may perform an electrocardiogram to assess these arrhythmias. Tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms while taking Sunitinib Synthon.
• If you have recently had problems with blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately 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, 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 microangiopathic hemolytic anemia (a condition characterized by the destruction of red blood cells). Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, disorientation, loss of vision, or seizures.
• If you have thyroid problems. Sunitinib Synthon may cause thyroid problems. Tell your doctor if you easily get tired, feel colder than other people, or experience a deepened voice while taking Sunitinib Synthon. Your doctor should check your thyroid function before starting treatment with Sunitinib Synthon and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to be treated with replacement thyroid hormone.
• 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 cholecystitis.
• If you have or have had liver problems. Inform your doctor if you experience any of the following symptoms of liver disorders while taking Sunitinib Synthon: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check liver function before starting treatment with Sunitinib Synthon, during treatment, and in case of clinical signs.

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