Suganet

Package leaflet: Information for the user

Suganet, 12.5 mg, hard capsules
Suganet, 25 mg, hard capsules
Suganet, 50 mg, hard capsules
Sunitinibum
Please read carefully this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor. See section 4.

Contents of the leaflet

1. What Suganet is and what it is 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 Suganet is and what it is used for

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

• gastrointestinal stromal tumours (GIST), a type of tumour of the stomach and intestines, when imatinib (another anticancer drug) is no longer effective or cannot be used;
• metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• pancreatic neuroendocrine tumours (pNET) (tumours arising 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 this medicine has been prescribed,
please consult your doctor.

2. Important information before taking Suganet

When not to take Suganet:

• 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 Suganet, discuss the following with your doctor:

• if the patient has high blood pressure. Suganet may increase blood pressure. The doctor may monitor blood pressure during treatment with Suganet, and the patient may require treatment with antihypertensive medicines if necessary.
• if the patient has or has previously had blood disorders, bleeding, or bruising. Treatment with Suganet may increase the risk of bleeding or alter the number of certain blood cells, which may lead to anaemia or affect the blood's ability to clot. If the patient is taking warfarin or acenocoumarol, anticoagulant medicines used to prevent blood clots, there may be an increased risk of bleeding. Inform the doctor about any bleeding episodes during treatment with Suganet.
• if the patient has heart problems. Suganet may cause heart-related issues. Inform the doctor if the patient experiences severe fatigue, shortness of breath, or swelling in the feet or ankles.
• if the patient has heart rhythm disorders. Suganet may cause irregular heart rhythms. During treatment with Suganet, the doctor may perform an electrocardiogram (ECG) to assess these disturbances. Inform the doctor if the patient experiences dizziness, fainting, or irregular heartbeat while taking Suganet.
• if the patient has recently experienced blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact the doctor immediately if, during treatment with Suganet, the patient develops 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 the patient has or has previously had an aneurysm (a bulging and weakening of a blood vessel wall) or a tear in the blood vessel wall.
• if the patient has or has previously had damage to the smallest blood vessels known as thrombotic microangiopathy. Inform the doctor if the patient develops fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.
• if the patient has thyroid gland problems. Suganet may cause thyroid dysfunction. Inform the doctor if the patient experiences fatigue, feels unusually cold, or develops hoarseness during treatment with Suganet. The doctor should check thyroid function before starting treatment with Suganet and regularly during treatment. If the thyroid does not produce enough thyroid hormone, the patient may require thyroid hormone replacement therapy.
• if the patient has or has previously had pancreatic dysfunction or gallbladder problems. Inform the doctor if the patient experiences any of the following symptoms: abdominal pain (upper abdomen), nausea, vomiting, or fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• if the patient has or has previously had liver disease. Inform the doctor if, during treatment with Suganet, the patient develops any of the following signs of liver dysfunction: itching, yellowing of the eyes or skin (jaundice), dark urine, or pain or discomfort in the upper right abdomen. The doctor should order blood tests to monitor liver function before starting treatment with Suganet, during treatment, and if clinical signs appear.
• if the patient has or has previously had kidney disease. The doctor will monitor kidney function.
• if the patient is scheduled for surgery or has recently undergone surgery. Suganet may affect wound healing. The medicine is usually discontinued before surgical procedures. The doctor will decide when to restart Suganet.
• The patient is advised to have a dental examination before starting treatment with Suganet.
• if the patient experiences oral pain, tooth or jaw pain, swelling or ulceration of the mouth, numbness or heaviness in the jaw, or loose teeth, inform the oncologist and dentist immediately.
• if the patient requires invasive dental treatment or oral surgery, inform the dentist about taking Suganet, especially if the patient is currently or has previously received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may have been prescribed for another condition.
• if the patient has or has previously had skin and subcutaneous tissue disorders. During treatment with this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (rapidly spreading infection of the skin and/or soft tissues, which may be life-threatening) may occur. Contact the doctor immediately if the patient develops signs of infection around skin lesions, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after discontinuation of Suganet. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during treatment with this medicine. These initially appear as red, target-shaped or circular spots, often with central blisters. The rash may progress to extensive blistering or skin peeling and may be life-threatening. If the patient develops a rash or any of the above-mentioned skin symptoms, seek medical attention immediately.
• if the patient has or has previously had seizures. Inform the doctor as soon as possible if the patient develops high blood pressure, headache, or vision loss.
• if the patient has diabetes. Blood glucose levels should be monitored regularly in diabetic patients to determine whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycaemia. Inform the doctor promptly if the patient experiences symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

Children and adolescents

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

Suganet and other medicines

Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.

Some medicines may affect the concentration of Suganet in the body. Inform the doctor if the patient is taking medicines containing any of 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 conditions (such as allergic 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 Suganet with food and drink

During treatment with Suganet, do not drink grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Women of childbearing potential should use an effective method of contraception during treatment with Suganet.

Women who are breastfeeding should inform their doctor. Breastfeeding is not recommended during treatment with Suganet.

Driving and using machines

If dizziness or significant fatigue occurs, exercise particular caution when driving or operating machinery.

Suganet contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., the medicine is considered "sodium-free".

3. How to take Suganet

This medicine should always be taken according to the doctor's instructions. In case of doubt, consult your doctor.

The doctor will prescribe the appropriate dose for each patient depending on the type of tumor. For patients being treated due to:

• GIST or MRCC, the usual dose is 50 mg taken once daily for 28 days (4 weeks), followed by a 14-day (2-week) treatment-free break, in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg taken once daily continuously.

The doctor will determine the appropriate dose for the individual patient and the treatment end date.

Suganet may be taken with or without food.

To open the blister packs, detach a single dose from the strip by tearing along the perforated line. Then peel back the foil on 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 too many capsules are taken, contact your doctor immediately. Medical intervention may be necessary.

Missing a dose of Suganet
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if the patient experiences any of the following adverse
reactions (see also section 2 "Important information before taking Suganet"):

• Heart problems. You should tell your doctor if the patient feels very tired, has shortness of breath or swelling of the feet and ankles. These may be symptoms of heart problems, which may include heart failure and problems with the heart muscle (cardiomyopathy).
• Lung diseases or breathing difficulties. You should tell your doctor if the patient develops cough, chest pain, sudden onset of breathlessness, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots travel to the lungs.
• Kidney function disorders. You should tell your doctor if the patient experiences changes in frequency or absence of urination, which may be symptoms of kidney failure.
• Bleeding. You should tell your doctor if the patient experiences any of the following symptoms or severe bleeding during treatment with Suganet: abdominal (stomach) 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.
• Tumour lysis leading to intestinal perforation. You should tell your doctor if the patient experiences severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other adverse reactions of Suganet may include:
Very common adverse reactions (may affect more than 1 in 10 people)

• Decrease in the number of platelets, red blood cells, and/or white blood cells (e.g. neutrophils)
• Dyspnoea
• Hypertension
• Severe fatigue, loss of strength
• Oedema caused by fluid accumulation under the skin and around the eyes, allergic rash (angioedema)
• Pain and/or irritation in the oral cavity, painful ulceration and/or inflammation, and/or dryness of the mouth, taste disturbances, gastrointestinal disorders, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss and/or reduced appetite
• Reduced thyroid activity (hypothyroidism)
• Dizziness
• Headache
• Nosebleeds
• Back pain, joint pain
• Pain in arms and legs
• Yellowing of the skin and/or skin discoloration, excessive skin pigmentation, hair color changes, rash on palms and soles, rash, dry skin
• Cough
• Fever
• Difficulty falling asleep

Common adverse reactions (may affect less than 1 in 10 people)

• Blood clots in blood vessels
• Inadequate blood supply to the heart due to embolism or narrowing of the coronary arteries
• Chest pain
• Reduced amount of blood pumped by the heart
• Fluid retention, including in the lung area
• Infections
• Complication following severe infection (blood infection), which may lead to tissue damage, organ failure, and death
• Decreased blood sugar levels (see section 2)
• Protein loss in urine, sometimes causing oedema
• Flu-like syndrome
• Abnormal blood test results, including 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 pain, muscle cramps
• Dryness of the nasal mucous membrane, sensation of nasal congestion
• Excessive tearing
• Skin sensory disturbances, itching, flaking and inflammation of the skin, blisters, acne, nail discoloration, hair loss
• Sensory disturbances in the limbs
• Disorders associated with increased or decreased sensitivity, especially to touch
• Heartburn
• Dehydration
• Hot flushes
• Abnormal urine colour
• Depression
• Chills

Uncommon adverse reactions (may affect less than 1 in 100 people)

• Life-threatening soft tissue infections, including the anogenital area (see section 2)
• Stroke
• Myocardial infarction caused by interruption or reduction of blood supply to the heart
• Changes in electrical function or heart rhythm disturbances
• Presence of fluid around the heart (pericardial effusion)
• Liver failure
• Abdominal (stomach) pain caused by inflammation of the pancreas
• Tumour lysis 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 to the skin
• Oral pain, tooth and/or jaw pain, swelling or ulceration of the oral cavity, numbness or sensation of heaviness in the jaw, or tooth mobility. These may be symptoms of jaw bone damage (osteonecrosis), see section 2 "Important information before taking Suganet"
• Excessive production of thyroid hormones leading to increased resting metabolism
• Impaired wound healing after surgical procedures
• Increased activity of muscle enzyme (creatine phosphokinase) in blood
• Excessive reaction to allergens, including hay fever, skin rash, itching, urticaria, swelling of any part of the body, and breathing difficulties
• Inflammation of the large intestine (colitis, ischemic colitis)

Rare adverse reactions (may affect less than 1 in 1000 people)

• Severe reaction affecting the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• Tumour lysis syndrome, a group of metabolic complications that may occur during cancer treatment. These complications are caused by products of decomposing tumour cells and may include: nausea, dyspnoea, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphate, and low calcium levels in blood), which may lead to kidney changes and acute kidney failure
• Abnormal muscle breakdown that may cause kidney disease (rhabdomyolysis)
• Abnormal changes in the brain that may cause a syndrome including headache, disorientation, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome)
• Painful skin ulceration (pyoderma gangrenosum)
• Inflammation of the liver
• Inflammation of the thyroid gland
• Damage to the smallest blood vessels called thrombotic microangiopathy

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

• Enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection)
• Lack of energy, confusion, drowsiness, loss of consciousness or coma – these symptoms may indicate toxic effects of high blood ammonia levels on the brain (hyperammonaemic encephalopathy)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

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 pack after: "EXP".
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Do not use this medicine if you notice that the packaging is damaged or if there are signs of prior opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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.
Other ingredients are:

• Capsule contents: povidone K30 LP, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (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.
Other ingredients are:

• Capsule contents: povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (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.
Other ingredients are:

• Capsule contents: povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, "Suganet contains sodium"), magnesium stearate;
• Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172);
• Printing ink: shellac, iron oxide black (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, printed in white ink with “SNB” and “12.5 mg” on the body. The capsule is filled with orange powder. Capsule size: 4 (approximately 14 mm in length).
Suganet 25 mg: hard gelatin capsule (capsule) with a caramel (light brown) cap and orange body, printed in white ink with “SNB” and “25 mg” on the body. The capsule is filled with orange powder. Capsule size: 3 (approximately 16 mm in length).
Suganet 50 mg: hard gelatin capsule (capsule) with a caramel cap and caramel (light brown) body, printed in white ink with “SNB” and “50 mg” on the body. The capsule is filled with orange powder. Capsule size: 1EL (elongated; approximately 20 mm in length).
The medicine is available in plastic bottles containing a desiccant and 30 capsules, in blisters containing a desiccant and 28 or 30 capsules, and in divided-dose perforated blister packs containing a desiccant with 28 x 1 or 30 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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
The Netherlands
Synthon, s.r.o.
Brněská 32/c.p. 597
678 01 Blansko
Czech Republic

This medicinal product is authorised for marketing in the European Economic Area under the following names:
NL: Suganet 12.5 mg hard capsules, Suganet 25 mg hard capsules, Suganet 50 mg hard 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