Sunitinib Stada

Package Leaflet: Information for the User

Sunitinib Stada, 50 mg, hard capsules

Sunitinib

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Sunitinib Stada contains the active substance sunitinib, which is a protein kinase inhibitor. This medicine is used to treat cancer, as it inhibits the activity of a specific group of proteins involved in the growth and spread of cancer cells.

Sunitinib Stada is used in adults to treat the following types of cancer:

• Gastrointestinal stromal tumour (GIST) - a type of stomach and intestine cancer, when imatinib (another anti-cancer medicine) is not effective or the patient cannot take imatinib.
• 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 the pancreas that produce hormones, which continue to grow or cannot be surgically removed.

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

2. Before you take Sunitinib Stada

When not to take Sunitinib Stada

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

Warnings and precautions

Before taking Sunitinib Stada, tell your doctor:

• If you have high blood pressure.Sunitinib Stada may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Stada and may prescribe medicines to lower your blood pressure if necessary.
• If you have or have had bleeding or blood disorders.Treatment with Sunitinib Stada may increase the risk of bleeding or changes in the number of certain blood cells, which can lead to anaemia 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 Stada.
• If you have heart problems.Sunitinib Stada may cause heart problems. Tell your doctor if you experience extreme tiredness, shortness of breath, or swelling of your feet or ankles.
• If you have irregular heart rhythms.Sunitinib Stada may cause irregular heart rhythms. During treatment with Sunitinib Stada, your doctor may perform an electrocardiogram to check for these irregularities. Tell your doctor if you experience dizziness, fainting, or irregular heartbeat during treatment with Sunitinib Stada.
• If you have recently had blood clots in your 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 during treatment with Sunitinib Stada.
• 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 haemolytic anaemia.Tell your doctor if you experience fever, tiredness, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems.Sunitinib Stada may cause thyroid problems. Tell your doctor if you experience extreme tiredness, feeling cold, or a deepened voice during treatment with Sunitinib Stada. Your doctor should check your thyroid function before starting treatment with Sunitinib Stada and regularly during treatment. If your thyroid does not produce enough thyroid hormones, you may need to take thyroid hormone replacement therapy.
• If you have or have had pancreas or gallbladder problems.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.Inform your doctor if you experience any of the following symptoms of liver problems during treatment with Sunitinib Stada: 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 your liver function before starting treatment with Sunitinib Stada, 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 Stada may affect wound healing. Sunitinib Stada is usually stopped in patients before surgery. Your doctor will decide when to restart treatment with Sunitinib Stada.
• Dental examination before starting treatment with Sunitinib is recommended.

Sunitinib Stada

• If you experience pain in your mouth, toothache, and/or jaw, swelling or ulceration of the mouth, numbness or a feeling of heaviness in the jaw, or tooth mobility, tell your doctor immediately.
• If you need invasive dental procedures or dental surgery, inform your dentist that you are taking Sunitinib Stada, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders.During treatment with this medicine, you may experience "pyoderma gangrenosum" (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening). Contact your doctor immediately if you experience signs of infection around a skin lesion, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after stopping sunitinib treatment. During treatment with sunitinib, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened targets or circular patches, often with central 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, contact your doctor immediately.
• If you have or have had seizures.Inform your doctor immediately if you experience high blood pressure, headache, or loss of vision.
• If you have diabetes.In patients with diabetes, blood sugar levels should be regularly monitored to assess whether the dose of anti-diabetic medication needs to be adjusted to minimize the risk of low blood sugar. Inform your doctor immediately if you experience any symptoms of low blood sugar (tiredness, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib Stada should not be used in patients under 18 years of age.

Sunitinib Stada with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Some medicines may affect the levels of Sunitinib Stada in your body. Inform your doctor if you are taking medicines containing the following active substances:

• Ketoconazole, itraconazole - used to treat fungal infections
• Erythromycin, clarithromycin, rifampicin - used to treat infections
• Ritonavir - used to treat HIV infection
• Dexamethasone - a corticosteroid used in various diseases (such as allergic reactions and/or respiratory disorders or skin diseases)
• Phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological diseases
• Herbal medicines containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety

Taking Sunitinib Stada with food and drink

Do not drink grapefruit juice while taking Sunitinib Stada.

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 Stada.

Do not breastfeed while taking Sunitinib Stada.

Driving and using machines

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

Sunitinib Stada contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Sunitinib Stada

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 you have.

For patients being treated for:

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

Your doctor will determine the correct dose for you and when to stop treatment with Sunitinib Stada.

Sunitinib Stada can be taken with or without food.

If you take more Sunitinib Stada than you should

If you accidentally take more capsules than prescribed, contact your doctor immediately, as you may need urgent medical attention.

If you forget to take Sunitinib Stada

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following side effects (see also section 2 "Before you take Sunitinib Stada"):
Heart problems.Tell your doctor if you experience extreme tiredness, shortness of breath, or swelling of your feet or ankles. These may be symptoms of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).

Lung problems or breathing difficulties.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 move 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 Stada: stomach pain and swelling (abdomen), vomiting blood, black and tarry stools, blood in urine, headache, or changes in consciousness, coughing up blood or bloody sputum from the lungs or airways.

Tumour lysis syndrome leading to intestinal perforation.Tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool, or changes in bowel movements.

Other side effects of Sunitinib Stada may include:

Very common: may affect more than 1 in 10 people

• Decreased 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.
• Pain and/or irritation in the mouth, painful ulcers and/or inflammation, and/or dryness of the mouth mucosa, taste disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in hands and feet.
• Discoloration of the skin and/or skin pigmentation, excessive skin pigmentation, hair colour changes, palmar-plantar erythrodysesthesia, rash, dry skin.
• Coughing.
• 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.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including around the lungs.
• Infections.
• Complications of severe infections (blood infection), which can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in urine, sometimes causing swelling.
• Flu-like symptoms.
• Abnormal blood test results, including abnormal activity of pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Haemorrhoids, anal pain, gum bleeding, difficulty swallowing or loss of swallowing ability.
• Burning or painful sensation of the tongue, inflammation of the mucous membrane of the digestive tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle cramps.
• Dryness of the nasal mucosa, nasal congestion.
• Excessive tearing.
• Skin sensitivity disturbances, itching, skin peeling, and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensitivity disturbances in the limbs.
• Sensitivity disturbances related to increased or decreased sensitivity, especially to touch
• Heartburn.
• Dehydration.
• Hot flushes.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including around the anus and genital organs (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood supply to the heart.
• Changes in the electrical or irregular heart rhythm.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreatitis.
• Tumour lysis syndrome leading to intestinal perforation.
• Inflammation (swelling or redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Pain in the mouth, toothache, and/or jaw, swelling or ulceration of the mouth, numbness or a 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 energy expenditure at rest.
• 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 various body parts, and difficulty breathing.
• Inflammation of the large intestine (colitis, ischaemic colitis).

Rare: may affect up to 1 in 1,000 people

• Severe skin reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome (TLS), which is a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and may include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, clouding of urine, 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 changes and acute kidney failure.
• Abnormal muscle breakdown, which can lead to kidney disease (rhabdomyolysis).
• Abnormal brain changes, which can cause a syndrome of symptoms including headache, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroiditis.
• Damaged smallest blood vessels called microangiopathic haemolytic anaemia.

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

• Enlargement and weakening of the wall of a blood vessel or rupture 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 blood ammonia levels on the brain (hyperammonaemic encephalopathy).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Stada

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

There are no special storage instructions for this medicine.

Do not use this medicine if 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Stada contains

• The active substance is sunitinib.

Sunitinib Stada, 50 mg, hard capsules

Each capsule contains 50 mg of sunitinib.

• Other ingredients are: capsule content:microcrystalline cellulose (E460), mannitol (E421), croscarmellose sodium, povidone K30 (E1201), magnesium stearate (E470b). Sunitinib Stada 50 mg, hard capsules
• capsule shell:iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.
• white ink:shellac, titanium dioxide (E171), propylene glycol (E1520).

What Sunitinib Stada looks like and contents of the pack

Sunitinib Stada 50 mg, hard capsules (capsules)

The hard gelatin capsules are size 1 with a light brown cap and light brown body, with "50 mg" printed in white ink on the body, containing yellow to orange granules.

Sunitinib Stada, hard capsules, are available in blisters containing 28 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer

Remedica Ltd.

Aharnon Street, Limassol Industrial Estate,

3056 Limassol,

Cyprus

Pharmacare Premium Ltd.

HHF003 Hal Far Industrial Estate,

Birzebbugia, BBG3000

Malta

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands Sunitinib Stada 50 mg hard capsules

Hungary Sunitinib Stada 50 mg hard capsules

Poland Sunitinib Stada

Date of last revision of the leaflet: 07/2024