Sunitinib Adamed

Package Leaflet: Information for the User

Sunitynib Adamed, 12.5 mg, hard capsules

Sunitynib Adamed, 25 mg, hard capsules Sunitynib Adamed, 37.5 mg, hard capsules

Sunitynib Adamed, 50 mg, hard capsules

Sunitynib

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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Sunitynib Adamed is and what it is used for

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

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestine cancer, when imatinib (another cancer medicine) 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, which are progressing and cannot be surgically removed.

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

2. Before you take Sunitynib Adamed

When not to take Sunitynib Adamed

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

Warnings and precautions

Before taking Sunitynib Adamed, tell your doctor:

• If you have high blood pressure.Sunitynib Adamed may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sunitynib Adamed, and you may need to take medicines to lower your blood pressure.
• If you have or have had bleeding or blood clotting problems.Treatment with Sunitynib Adamed 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 Sunitynib Adamed.
• If you have heart problems.Sunitynib Adamed 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 heart rhythm problems.Sunitynib Adamed may cause abnormal heart rhythms. During treatment with Sunitynib Adamed, your doctor may perform an electrocardiogram to check for these problems. Tell your doctor if you feel dizzy, faint, or have an abnormal heart rhythm while taking Sunitynib Adamed.
• If you have recently had blood clots in your veins and/or arteries (a type of blood vessel), including stroke, heart attack, embolism, or thrombosis.Tell 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 (a bulge or 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 where small blood vessels are damaged, leading to anemia).Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems.Sunitynib Adamed may cause thyroid problems. Tell your doctor if you feel tired, feel cold, or have a hoarse voice while taking Sunitynib Adamed. Your doctor should check your thyroid function before starting Sunitynib Adamed and regularly during treatment. If your thyroid is not producing enough thyroid hormone, you may need to take replacement thyroid hormone.
• 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 signs of pancreatitis or gallbladder inflammation.
• If you have 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 Sunitynib Adamed, during treatment, and if you experience any symptoms.

and/or

• If you have kidney problems.Your doctor will monitor your kidney function.
• If you are going to have surgery or have recently had surgery.Sunitynib Adamed may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitynib Adamed.
• You are advised to have a dental check-up before starting treatment with Sunitynib Adamed.

Sunitynib Adamed:

• if you experience mouth pain, toothache, or jaw pain, swelling or ulceration of the mouth, numbness or heaviness of the jaw, or tooth mobility, tell your doctor and dentist immediately.
• if you need invasive dental treatment or surgery, tell your dentist that you are taking Sunitynib Adamed, especially if you are also taking or have taken bisphosphonates intravenously. Bisphosphonates are medicines used to prevent bone problems, which may be taken for another condition.
• If you have or have had skin and subcutaneous tissue disorders.While taking this medicine, you may experience a painful skin rash (pyoderma gangrenosum) or a life-threatening infection of the skin and soft tissues (necrotizing fasciitis). Tell your doctor immediately if you experience symptoms of infection around a skin wound, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after stopping Sunitynib Adamed. While taking this medicine, 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 skin symptoms, tell your doctor immediately.
• If you have or have had seizures.Tell your doctor as soon as possible 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 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 (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitynib Adamed is not recommended for patients under 18 years of age.

Sunitynib Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription and those you plan to take.
Some medicines may affect the levels of Sunitynib Adamed in your body. Tell your doctor if you are taking medicines containing the following active substances:

• 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 products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Taking Sunitynib Adamed with food and drink

Do not drink grapefruit juice while taking Sunitynib Adamed.

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 can become pregnant should use effective contraception during treatment with Sunitynib Adamed.
Women who are breastfeeding should tell their doctor. Do not breastfeed while taking Sunitynib Adamed.

Driving and using machines

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

Sunitynib Adamed contains mannitol

It may have a mild laxative effect.

3. How to take Sunitynib Adamed

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.
• 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 Sunitynib Adamed.
Sunitynib Adamed can be taken with or without food.

If you take more Sunitynib Adamed than you should

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

If you forget to take Sunitynib Adamed

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

4. Possible side effects

Like all medicines, Sunitynib Adamed can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects (see also section 2):
Heart problems.Tell your doctor if you feel very tired, have shortness of breath, or swelling in your feet or ankles. These may be signs of heart problems, including heart failure and problems with the heart muscle (cardiomyopathy).
Lung problems or difficulty breathing.Tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be signs 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 signs of kidney failure.
Bleeding.Tell your doctor if you experience any of the following symptoms or severe bleeding while taking Sunitynib Adamed: stomach pain or swelling; vomiting blood; black or tarry stools; blood in urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor breakdown leading to bowel 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 Sunitynib Adamed 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 fatigue, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, deep.
• Mouth pain and/or soreness, painful mouth ulcers, and/or inflammation, and/or dry mouth, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain or swelling, loss of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• 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.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication of severe infection (sepsis) that can lead to tissue damage, organ failure, and death.
• Low blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Pseudo-flu 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 sensation or pain in the mouth, 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 cramps.
• Dryness of the nasal mucosa, feeling of nasal congestion.
• Excessive tearing.
• Skin sensitivity disturbances, itching, skin peeling, and/or inflammation, blisters, acne, nail discoloration, hair loss.
• Skin sensation disturbances.
• Sensitivity disturbances, 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 the soft tissues, including the perianal area (see section 2).
• Stroke.
• Heart attack caused by a blockage or narrowing of the coronary arteries.
• Changes in the electrical activity or rhythm of the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain (abdomen) caused by pancreatitis.
• Tumor breakdown leading to bowel perforation (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.
• Mouth pain, toothache, or jaw pain, swelling or ulceration of the mouth, numbness or heaviness of the jaw, or tooth mobility. These may be signs of jawbone damage (osteonecrosis), see section 2.
• Overproduction 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 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, changes in 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, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin rash (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Microangiopathic hemolytic anemia (a condition where small blood vessels are damaged, leading to anemia).

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

• Enlargement and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysm and arterial dissection).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunitynib Adamed

• 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 and blister after EXP. The expiry date refers to the last day of that month.
• No special storage precautions are required.
• 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Sunitynib Adamed contains

• The active substance is sunitinib (in the form of sunitinib malate).

Sunitynib Adamed 12.5 mg hard capsules

Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium Povidone K-25 Magnesium stearate
• Capsule shell:Gelatin Iron oxide red (E172) Titanium dioxide (E171) Purified water

Sunitynib Adamed 25 mg hard capsules

Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium Povidone K-25 Magnesium stearate
• Capsule shell:Gelatin Iron oxide yellow (E172) Iron oxide red (E172) Titanium dioxide (E171) Purified water

Sunitynib Adamed 37.5 mg hard capsules

Each capsule contains sunitinib malate equivalent to 37.5 mg of sunitinib.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium Povidone K-25 Magnesium stearate
• Capsule shell:Gelatin Iron oxide yellow (E172) Titanium dioxide (E171) Purified water

Sunitynib Adamed 50 mg hard capsules

Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib.
The other ingredients are:

• Capsule content:Mannitol Croscarmellose sodium Povidone K-25 Magnesium stearate
• Capsule shell:Gelatin Iron oxide yellow (E172) Iron oxide red (E172) Titanium dioxide (E171) Purified water

What Sunitynib Adamed looks like and contents of the pack

Sunitynib Adamed 12.5 mg hard capsulesare red, opaque, hard gelatin capsules.
Sunitynib Adamed 25 mg hard capsulesare red and orange, opaque, hard gelatin capsules.
Sunitynib Adamed 37.5 mg hard capsulesare yellow, opaque, hard gelatin capsules.
Sunitynib Adamed 50 mg hard capsulesare orange, opaque, hard gelatin capsules.
The medicine is available in blisters containing 28 capsules in a cardboard box.

Marketing Authorisation Holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

Importer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria,
2565-187 Dois Portos
Portugal

This medicinal product is authorised in the Member States of the EEA under the following names:

Greece
Sunitinib/ Ariti
Poland
Sunitynib Adamed

Date of last revision of the leaflet: 06.2022