Suganet

Package Leaflet: Information for the User

Suganet, 12.5 mg, hard capsules

Suganet, 25 mg, hard capsules

Suganet, 50 mg, hard capsules

Sunitinib

It is very important that you read the contents of this leaflet carefully before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, please 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 leaflet, please inform your doctor. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Suganet and what is it used for

Suganet contains the active substance sunitinib, which is a protein kinase inhibitor. Suganet is used to treat cancer by inhibiting the activity of a specific group of proteins involved in the growth and spread of cancer cells.

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

• gastrointestinal stromal tumors (GIST), a type of stomach and intestinal cancer, when imatinib (another cancer medicine) has stopped working 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 (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 Suganet works or why it has been prescribed for you, please ask your doctor.

2. Important information before taking Suganet

When not to take Suganet:

• 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 Suganet, you should discuss the following with your doctor:

• if you have high blood pressure. Suganet may increase blood pressure. Your doctor may check your blood pressure during treatment with Suganet, and you may need to take medicines to lower your blood pressure if necessary.
• if you have or have had bleeding or blood clotting problems. Treatment with Suganet may increase the risk of bleeding or changes in blood cell counts, which can lead to 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. You should inform your doctor about any bleeding during treatment with Suganet.
• if you have heart problems. Suganet may cause heart problems. You should inform your doctor if you experience tiredness, shortness of breath, or swelling of the feet or ankles.
• if you have irregular heart rhythms. Suganet may cause irregular heart rhythms. During treatment with Suganet, your doctor may perform an electrocardiogram to assess these irregularities. You should inform your doctor if you experience dizziness, fainting, or irregular heart rhythms during treatment with Suganet.
• if you have recently had blood clots in the veins and/or arteries (including stroke, heart attack, embolism, or thrombosis). You should contact your doctor immediately if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, or difficulty breathing, weakness or numbness of 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 a condition called thrombotic microangiopathy (a disorder that affects the small blood vessels). You should inform your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• if you have thyroid problems. Suganet may cause thyroid problems. You should inform your doctor if you experience weight loss, feel cold, or have a deep voice during treatment with Suganet. Your doctor should check your thyroid function before starting treatment with Suganet and regularly during treatment. If your thyroid does not produce enough thyroid hormone, you may need to take replacement thyroid hormone.
• if you have or have had problems with your pancreas or gallbladder. You should inform your doctor if you experience abdominal pain, nausea, vomiting, or fever, which may be symptoms of pancreatitis or gallbladder inflammation.
• if you have or have had liver disease. You should inform your doctor if you experience symptoms of liver problems, such as 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 Suganet, during treatment, and if you experience any symptoms of liver problems.
• if you have or have had kidney disease. Your doctor will monitor your kidney function.
• if you are going to have surgery or have recently had surgery. Suganet may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Suganet.
• You are advised to have a dental check-up before starting treatment with Suganet:
• if you experience mouth pain, toothache, or jaw pain, swelling, or mouth ulceration, difficulty swallowing, or tooth mobility, you should inform your doctor and dentist immediately.
• if you need invasive dental treatment or surgery, you should inform your dentist that you are taking Suganet, especially if you are also taking or have taken bisphosphonates. Bisphosphonates are medicines used to prevent bone problems that may be taken for another condition.
• if you have or have had skin and subcutaneous tissue disorders. During treatment with Suganet, you may experience painful skin ulcers (pyoderma gangrenosum) or a condition called necrotizing fasciitis (a rapidly spreading infection of the skin and soft tissues that can be life-threatening). You should contact your doctor immediately if you experience symptoms of infection around a skin lesion, such as fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after stopping treatment with Suganet. During treatment with Suganet, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme) have been observed, which initially appear as red 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 can be life-threatening. If you experience a rash or any of the above skin symptoms, you should contact your doctor immediately.
• if you have or have had seizures. You should inform 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. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and Adolescents

Suganet is not recommended for patients under 18 years of age.

Suganet and Other Medicines

You should inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those obtained without a prescription.

Some medicines may affect the levels of Suganet in your body. You should inform 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 to treat various conditions (such as allergic disorders, respiratory problems, or skin conditions);
• 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.

Taking Suganet with Food and Drink

While taking Suganet, you should not drink grapefruit juice.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Women who can become pregnant should use effective contraception during treatment with Suganet.

Women who are breastfeeding should inform their doctor. You should not breastfeed while taking Suganet.

Driving and Using Machines

If you experience dizziness or significant fatigue, you should be cautious when driving or operating machinery.

Suganet Contains Sodium

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

3. How to Take Suganet

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.

In the case of 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 treatment), in 6-week treatment 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 treatment with Suganet.

Suganet can be taken with or without food.

To open the blisters, you should tear off one single dose from the blister strip, along the perforated line. Then, peel off the foil from the blister and remove the capsule. Do not push the capsule through the foil, as this may damage it.

Taking More than the Recommended Dose of Suganet

If you have taken too many capsules, you should contact your doctor immediately.

Medical attention may be necessary.

Missing a Dose of Suganet

You should not take a double dose to make up for a missed dose.

4. Possible Side Effects

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

You should contact your doctor immediately if you experience any of the following side effects (see also section 2 "Important information before taking Suganet"):

• heart problems. You should inform your doctor if you feel very tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, which can include heart failure and problems with the heart muscle (cardiomyopathy).
• lung disease or breathing difficulties. You should inform 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. You should inform your doctor if you experience changes in urination frequency or inability to urinate, which may be symptoms of kidney failure.
• bleeding. You should inform your doctor if you experience any of the following symptoms or severe bleeding during treatment with Suganet: abdominal pain and swelling; vomiting blood; black, tarry stools; blood in the urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
• tumor lysis syndrome leading to intestinal perforation. You should inform your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.

Other side effects of Suganet may include:

Very Commonside effects (may affect more than 1 in 10 people)

• decrease in platelet count, 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, hives
• mouth pain, toothache, or jaw pain, swelling, or mouth ulceration, dry mouth, changes in taste, gastrointestinal disorders, nausea, vomiting, diarrhea, constipation, abdominal pain or swelling, loss of appetite or decreased appetite
• decrease in thyroid activity (hypothyroidism)
• dizziness
• headache
• nosebleeds
• back pain, joint pain
• arm and leg pain
• skin discoloration and/or pigmentation, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia (redness and swelling of the skin on the palms and soles), rash, dry skin
• coughing
• fever
• difficulty sleeping

Commonside effects (may affect up to 1 in 10 people)

• blood clots in blood vessels
• insufficient blood supply to the heart due to blockage or narrowing of the coronary arteries
• chest pain
• decrease in the amount of blood pumped by the heart
• fluid accumulation, including in the lungs
• infections
• complications after severe infection (sepsis), which can lead to tissue damage, organ failure, and death
• decrease in blood sugar levels (see section 2)
• protein loss in the urine, sometimes causing swelling
• flu-like symptoms
• abnormal blood test results, including pancreatic and liver enzymes
• high levels of uric acid in the blood
• hemorrhoids, anal pain, rectal bleeding, difficulty swallowing, or loss of swallowing ability
• burning or pain in the mouth or throat, inflammation of the mucous membranes, excessive gas in the stomach or intestines
• weight loss
• musculoskeletal pain (muscle and bone pain), muscle weakness, fatigue, muscle cramps
• dryness of the nasal mucous membranes, feeling of nasal congestion
• excessive tearing
• skin sensitivity disorders, redness, and inflammation, peeling, and inflammation of the skin
• abnormal sensations in the skin
• heartburn
• dehydration
• heat strokes
• abnormal urine color
• depression
• chills

Uncommonside effects (may affect up to 1 in 100 people)

• life-threatening infection of the skin and soft tissues (necrotizing fasciitis)
• stroke
• heart attack caused by interruption or reduction of blood flow to the heart
• changes in heart rhythm or irregularities
• fluid accumulation around the heart (pericardial effusion)
• liver failure
• abdominal pain caused by pancreatitis
• tumor lysis syndrome leading to intestinal perforation
• inflammation of the gallbladder (cholecystitis) with or without gallstones
• formation of abnormal connections between one body cavity and another or with the skin (fistula)
• mouth pain, toothache, or jaw pain, swelling, or mouth ulceration, difficulty swallowing, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2 "Important information before taking Suganet"
• overproduction of thyroid hormones leading to increased metabolism
• abnormal wound healing after surgery
• increase in muscle enzyme activity (creatine phosphokinase) in the blood
• allergic reactions, including fever, skin rash, itching, hives, swelling of any part of the body, and difficulty breathing
• inflammation of the colon (colitis, ischemic colitis)

Rareside effects (may affect up to 1 in 1000 people)

• life-threatening skin and mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, and 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, and changes in 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 ulcers (pyoderma gangrenosum)
• liver inflammation
• thyroid inflammation
• damage to the small blood vessels (thrombotic microangiopathy)

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)
• lack of energy, lethargy, somnolence, 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 leaflet, you should inform 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, 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 Suganet

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 stated.

Store in the original package to protect from moisture.

There are no special storage instructions for this medicine.

Do not use this medicine if you notice that the packaging is damaged or if there are signs of previous attempts to open it.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Suganet Contains

Suganet 12.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib.

The other ingredients are:

• Capsule content:povidone K30 LP, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell:gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
• Printing ink:shellac, titanium dioxide (E171), propylene glycol.

Suganet 25 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib.

The other ingredients are:

• Capsule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell:gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
• Printing ink:shellac, titanium dioxide (E171), propylene glycol.

Suganet 50 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib.

The other ingredients are:

• Capsule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell:gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
• Printing ink:shellac, black iron oxide (E172), propylene glycol.

What Suganet Looks Like and Contents of the Pack

Suganet 12.5 mg: hard gelatin capsule (capsule) with an orange cap and orange body, with white ink printing "SNB" and "12.5 mg" on the body. The capsule is filled with an orange powder. Capsule size: 4 (length approximately 14 mm).

Suganet 25 mg: hard gelatin capsule (capsule) with a caramel (light brown) cap and orange body, with white ink printing "SNB" and "25 mg" on the body. The capsule is filled with an orange powder. Capsule size: 3 (length approximately 16 mm).

Suganet 50 mg: hard gelatin capsule (capsule) with a caramel cap and caramel (light brown) body, with white ink printing "SNB" and "50 mg" on the body. The capsule is filled with an orange powder. Capsule size: 1EL (elongated; length approximately 20 mm).

The medicine is available in plastic bottles with a desiccant, containing 30 capsules, in blisters with a desiccant, containing 28 or 30 capsules, and in perforated unit dose blisters with a desiccant, containing 28 x 1 or 30 x 1 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland

Manufacturer

Synthon Hispania, S.L., Calle Castello 1, 08830 Sant Boi de Llobregat, Barcelona, Spain

Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands

Synthon, s.r.o., Brnenska 32/č.p. 597, 678 01 Blansko, Czech Republic

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

NL: Suganet 12,5 mg harde capsules, Suganet 25 mg harde capsules, Suganet 50 mg harde capsules

BG: Suganet 12.5 mg, Suganet 25 mg, Suganet 50 mg

HU: Suganet 12,5 mg kemény kapszula, Suganet 25 mg kemény kapszula, Suganet 50 mg kemény kapszula

PL: Suganet 12.5 mg, Suganet 25 mg, Suganet 50 mg

Date of Last Revision of the Leaflet: August 2024