Sunitinib G.l. Pharma

Leaflet included in the packaging: patient information

Sunitinib G.L. Pharma, 12.5 mg, hard capsules
Sunitinib G.L. Pharma, 25 mg, hard capsules
Sunitinib G.L. Pharma, 50 mg, hard capsules
Sunitinib
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed to you personally. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sunitinib G.L. Pharma and what is it used for

Sunitinib G.L. Pharma contains the active substance sunitinib, which is a protein kinase inhibitor. Sunitinib G.L. Pharma 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 G.L. Pharma is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumors (GISTs), a type of stomach and intestinal cancer, when imatinib (another anticancer 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 (pNETs), 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 Sunitinib G.L. Pharma works or why it has been prescribed for you, you should consult your doctor.

2. Important information before taking Sunitinib G.L. Pharma

When not to take Sunitinib G.L. Pharma:

• 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 Sunitinib G.L. Pharma, you should discuss the following with your doctor:

• If you have high blood pressure.Sunitinib G.L. Pharma may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib G.L. Pharma, and you may need to be treated with blood pressure-lowering medicines if necessary.
• If you have or have had bleeding or blood disorders.Treatment with Sunitinib G.L. Pharma 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, you may be at increased risk of bleeding. You should tell your doctor about any bleeding during treatment with Sunitinib G.L. Pharma.
• If you have heart disease.Sunitinib G.L. Pharma may cause heart disease. You should tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of the feet or ankles.
• If you have heart rhythm disorders.Sunitinib G.L. Pharma may cause abnormal heart rhythms. During treatment with Sunitinib G.L. Pharma, your doctor may perform an electrocardiogram to assess these disorders. You should tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms while taking Sunitinib G.L. Pharma.
• If you have recently had blood clots in the veins and/or arteries (types of blood vessels), 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, difficulty breathing, 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).You should tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid disease.Sunitinib G.L. Pharma may cause thyroid disease. You should tell your doctor if you experience weight loss, feel cold, or have a hoarse voice while taking Sunitinib G.L. Pharma. Your doctor should check your thyroid function before starting treatment with Sunitinib G.L. Pharma 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 pancreatic or gallbladder disorders.You should 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 disease.You should inform your doctor if you experience any of the following symptoms of liver disorders while taking Sunitinib G.L. Pharma: yellowing of the skin or eyes, dark urine, or pain and discomfort in the right upper abdomen. Your doctor should order blood tests to check liver function before starting treatment with Sunitinib G.L. Pharma and during treatment.

Sunitinib G.L. Pharma, during and after treatment, if clinically indicated.

• 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.Sunitinib G.L. Pharma may affect wound healing. The medicine is usually discontinued in patients before surgery. Your doctor will decide when to restart Sunitinib G.L. Pharma.
• You are advised to have a dental check-up before starting treatment with Sunitinib G.L. Pharma.

Sunitinib G.L. Pharma:

• If you experience mouth pain, toothache, or jaw pain, swelling, or mouth ulcers, difficulty swallowing, or a feeling of heaviness in the jaw, or tooth mobility, you should inform your doctor and dentist immediately.
• If you need invasive dental treatment or oral surgery, you should inform your dentist that you are taking Sunitinib G.L. Pharma, 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.While taking 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). You should contact 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 disorders usually resolve after discontinuation of Sunitinib G.L. Pharma. While taking this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as red patches with a target-like shape or circular patches, often with centrally located blisters. The rash can progress to widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned 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 antidiabetic medicine needs to be adjusted to minimize the risk of hypoglycemia. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar, such as fatigue, palpitations, excessive sweating, hunger, or loss of consciousness.

Children and adolescents

Sunitinib G.L. Pharma is not recommended for patients under 18 years of age.

Sunitinib G.L. Pharma and other medicines

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

Some medicines may affect the levels of Sunitinib G.L. Pharma in your body. You should 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 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,
• Products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Taking Sunitinib G.L. Pharma with food and drink

While taking Sunitinib G.L. Pharma, you should not drink grapefruit juice.

Pregnancy and breastfeeding

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

Women who can become pregnant should use effective contraception during treatment with Sunitinib G.L. Pharma.

Women who are breastfeeding should inform their doctor. You should not breastfeed while taking Sunitinib G.L. Pharma.

Driving and using machines

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

Sunitinib G.L. Pharma contains sodium

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

3. How to take Sunitinib G.L. Pharma

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult 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 treatment cycles.
• pNET, the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the appropriate dose for you and when to stop taking Sunitinib G.L. Pharma.

Sunitinib G.L. Pharma can be taken with or without food.

Taking a higher dose of Sunitinib G.L. Pharma than prescribed

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

Medical intervention may be necessary.

Missing a dose of Sunitinib G.L. Pharma

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

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 "Important information before taking Sunitinib G.L. Pharma"): Heart disease.You should tell your doctor if you feel extremely tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart disease, which can include heart failure and heart muscle disease (cardiomyopathy).

Lung disease or breathing difficulties.You should 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 travel to the lungs.

Kidney function disorders.You should tell your doctor if you experience changes in urination frequency or inability to urinate, which may be symptoms of kidney failure.

Bleeding.You should tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitinib G.L. Pharma: stomach pain and swelling (abdomen); 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 tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function.

Other side effects of Sunitinib G.L. Pharma may include:

Very common: may affect more than 1 in 10 people

• Decreased platelet count, red blood cells, and/or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, weakness.
• Swelling caused by fluid accumulation under the skin and around the eyes, allergic rash, hypokalemia.
• Mouth pain, toothache, or jaw pain, swelling, or mouth ulcers, difficulty swallowing, or a feeling of heaviness in the jaw, or tooth mobility.
• Decreased thyroid function (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Arm and leg pain.
• Yellowing of the skin and/or discoloration, excessive pigmentation of the skin, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

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 heart function.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication of severe infection (sepsis) that can lead to tissue damage, organ failure, and death.
• Decreased 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, rectal 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, fatigue, muscle cramps.
• Dryness of the nasal mucosa, feeling of nasal congestion.
• Excessive tearing.
• Disorders of skin sensation, redness, scaling, and inflammation of the skin, blisters, itching, discoloration of the nails, hair loss.
• Disorders of sensation in the extremities.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Heat strokes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the perineal area (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood flow to the heart.
• Changes in heart rhythm or conduction.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain caused by pancreatitis.
• Tumor lysis syndrome leading to intestinal perforation.
• Inflammation 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 mouth ulcers, difficulty swallowing, or a feeling of heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones leading to increased resting metabolism.
• Impaired wound healing after surgery.
• Increased levels of the muscle enzyme creatine phosphokinase in the blood.
• Excessive allergic reaction, including hay 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 reactions (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, cloudy 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 damage and acute kidney failure.
• Abnormal muscle breakdown, which can cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain, 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 gland inflammation.
• Microangiopathic hemolytic anemia (a condition characterized by the destruction of red blood cells).

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, drowsiness, loss of consciousness, or sleepiness - these symptoms may be signs of the toxic effect of high blood ammonia levels on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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.

Reporting side effects can help gather more information on the safety of this medicine.

5. How to store Sunitinib G.L. Pharma

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

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 packaging and other information

What Sunitinib G.L. Pharma contains

• The active substance of the medicine is sunitinib.

Sunitinib G.L. Pharma, 12.5 mg, hard capsules
Each capsule contains 12.5 mg of sunitinib.

Sunitinib G.L. Pharma, 25 mg, hard capsules
Each capsule contains 25 mg of sunitinib.

Sunitinib G.L. Pharma, 50 mg, hard capsules
Each capsule contains 50 mg of sunitinib.

• Other ingredients are: Capsule content:microcrystalline cellulose, mannitol, sodium croscarmellose (see section 2 "Sunitinib G.L. Pharma contains sodium"), povidone K30, magnesium stearate. Sunitinib G.L. Pharma, 12.5 mg, hard capsules
• Capsule shell:red iron oxide (E172), titanium dioxide (E171), gelatin.
• White printing ink:shellac, titanium dioxide (E171), propylene glycol (E1520). Sunitinib G.L. Pharma, 25 mg, hard capsules
• Capsule shell:black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
• White printing ink:shellac, titanium dioxide (E171), propylene glycol (E1520). Sunitinib G.L. Pharma, 50 mg, hard capsules
• Capsule shell:black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin,
• White printing ink:shellac, titanium dioxide (E171), propylene glycol (E1520),

What Sunitinib G.L. Pharma looks like and contents of the pack

Sunitinib G.L. Pharma, 12.5 mg, hard capsules
Gelatin capsules, size 4 (approximately 14.3 mm in length), with an orange cap and orange body, with white printing "12.5 mg" on the body, containing yellow to orange granules.

Sunitinib G.L. Pharma, 25 mg, hard capsules
Gelatin capsules, size 3 (approximately 15.9 mm in length), with a caramel cap and orange body, with white printing "25 mg" on the body, containing yellow to orange granules.

Sunitinib G.L. Pharma, 50 mg, hard capsules
Gelatin capsules, size 1 (approximately 19.4 mm in length), with a caramel cap and caramel body, with white printing "50 mg" on the body, containing yellow to orange granules.

Aluminum/OPA/Aluminum/PVC blisters containing 28 or 30 hard capsules in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1, Lannach
8502, Austria
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate,
3056 Limassol,
Cyprus
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Birzebbugia, BBG3000
Malta