Sunitinib Medical Vallei

Package Leaflet: Information for the Patient

Sunitinib Medical Valley, 12.5 mg, hard capsules

Sunitinib Medical Valley, 25 mg, hard capsules Sunitinib Medical Valley, 37.5 mg, hard capsules

Sunitinib Medical Valley, 50 mg, hard capsules

Sunitinib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Sunitinib Medical Valley and what is it used for

Sunitinib Medical Valley contains the active substance sunitinib, which is a protein kinase inhibitor. Sunitinib Medical Valley is used to treat cancer. It works by blocking the activity of a special group of proteins that are involved in the growth and spread of cancer cells.

Sunitinib Medical Valley 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 Sunitinib Medical Valley works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Sunitinib Medical Valley

When not to take Sunitinib Medical Valley

• 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 Medical Valley, discuss it with your doctor.

If you have high blood pressure. Sunitinib Medical Valley may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Medical Valley, and you may need to take medicines to lower your blood pressure.

• If you have or have had blood disorders, bleeding, or bruising. Treatment with Sunitinib Medical Valley 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 Sunitinib Medical Valley.
• If you have heart problems. Sunitinib Medical Valley may cause heart problems. Tell your doctor if you experience extreme tiredness, shortness of breath, or swelling of the feet or ankles.
• If you have heart rhythm disorders. Sunitinib Medical Valley may cause abnormal heart rhythms. During treatment with Sunitinib Medical Valley, your doctor may perform an electrocardiogram to assess these disorders. Tell your doctor if you experience dizziness, fainting, or abnormal heart rhythms during treatment with Sunitinib Medical Valley.
• If you have recently had blood clots in the veins and/or arteries, 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.
• 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 where small blood vessels are damaged). Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• If you have thyroid problems. Sunitinib Medical Valley may cause thyroid problems. Tell your doctor if you easily get tired, feel colder than others, or experience a deepened voice during treatment with Sunitinib Medical Valley. Your doctor should check your thyroid function before starting treatment with Sunitinib Medical Valley 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 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. 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 liver function before starting treatment with Sunitinib Medical Valley, during treatment, and if there are clinical signs.

Your doctor will monitor your kidney function.

• If you are going to have surgery or have recently had surgery. Sunitinib Medical Valley may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitinib Medical Valley.
• Dental examination before starting treatment with Sunitinib Medical Valley

Sunitinib Medical Valley:

• If you experience pain in the mouth, toothache, and/or jaw pain, swelling, or mouth ulceration, numbness, or a feeling of heaviness in the jaw, or tooth mobility, tell your doctor immediately.
• If you need invasive dental treatment or oral surgery, tell your dentist that you are taking Sunitinib Medical Valley, especially if you are also taking or have taken intravenous bisphosphonates. 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. During treatment with this medicine, pyoderma gangrenosum (painful skin ulceration) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening) may occur. Contact your doctor immediately if you experience symptoms of infection around a skin lesion, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after stopping sunitinib treatment. During sunitinib treatment, 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 round 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 the above-mentioned skin symptoms, contact 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

Sunitinib Medical Valley is not recommended for patients under 18 years of age.

Sunitinib Medical Valley 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 that have not been prescribed before.

Some medicines may affect the levels of Sunitinib Medical Valley in your body. Tell 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,
• Herbal products containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Sunitinib Medical Valley with food and drink

Do not drink grapefruit juice while taking Sunitinib Medical Valley.

Pregnancy and breastfeeding

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

Women who may become pregnant should use effective contraception during treatment with Sunitinib Medical Valley.

Women who are breastfeeding should inform their doctor. Do not breastfeed while taking Sunitinib Medical Valley.

Driving and using machines

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

Sunitinib Medical Valley contains sodium

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

Sunitinib Medical Valley 37.5 mg contains orange yellow FCF and tartrazine.

Sunitinib Medical Valley 37.5 mg contains orange yellow FCF (E 110) and tartrazine (E 102), which may cause allergic reactions.

3. How to take Sunitinib Medical Valley

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 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 Sunitinib Medical Valley.

Sunitinib Medical Valley can be taken with or without food.

Taking more than the recommended dose of Sunitinib Medical Valley

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

Missing a dose of Sunitinib Medical Valley

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

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 serious side effects (see also section 2 "Important information before taking Sunitinib Medical Valley"):

Heart problems. Tell 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, including heart failure and problems with the heart muscle (cardiomyopathy).

Lung or breathing problems. 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 Medical Valley: stomach pain or 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 bowel perforation. Tell your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.

Other side effects of Sunitinib Medical Valley 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 tiredness, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, allergic rash.
• Pain and/or irritation in the mouth, painful mouth ulcers, and/or inflammation and/or dryness of the mouth mucosa, taste disorders, stomach disorders, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing and/or discoloration of the skin, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin.
• Coughing.
• Fever.
• Sleep disorders.

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), which can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Flu-like 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 or pain in 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, feeling of nasal congestion.
• Excessive tearing.
• Skin sensitivity disorders, itching, skin peeling, and/or inflammation, blisters, acne, nail discoloration, hair loss.
• Skin sensation disorders.
• Sensitivity disorders, including increased or decreased sensitivity, 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 soft tissues, including the perianal and genital area (see section 2).
• Stroke.
• Heart attack caused by a blockage or narrowing of the coronary arteries.
• Changes in heart rhythm or electrical activity.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Stomach pain caused by pancreatitis.
• Tumor lysis syndrome leading to bowel perforation.
• Inflammation 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 pain, swelling, or mouth ulceration, 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 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 1,000 people

• Severe skin and/or mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome, 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 can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, decreased 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, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged small blood vessels, known as microangiopathic hemolytic anemia.

Unknown frequency (cannot be estimated from 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, confusion, drowsiness, 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 package leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

You can also report side effects 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 Medical Valley

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of the month.
• There are no special storage instructions for this medicine.
• 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. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Medical Valley contains

Sunitinib Medical Valley, 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 (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, iron oxide red (E 172), titanium dioxide (E 171), iron oxide black (E 172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

Sunitinib Medical Valley, 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 (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

Sunitinib Medical Valley, 37.5 mg, hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.

The other ingredients are:

• Capsule content: povidone (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), orange yellow FCF (E 110), tartrazine (E 102).
• Printing ink: shellac, propylene glycol, ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

Sunitinib Medical Valley, 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 (K-25), mannitol, sodium croscarmellose, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

What Sunitinib Medical Valley looks like and contents of the pack

Sunitinib Medical Valley 12.5 mg is supplied in the form of hard capsules with a dark brown, opaque cap and a dark brown, opaque body, size 13.8-14.8 mm, with a white print "LP" on the cap and "650" on the body, containing yellow to orange granules.

Sunitinib Medical Valley 25 mg is supplied in the form of hard capsules with a light brown, opaque cap and a dark brown, opaque body, size 15.4-16.4 mm, with a white print "LP" on the cap and "651" on the body, containing yellow to orange granules.

Sunitinib Medical Valley 37.5 mg is supplied in the form of hard capsules with a yellow, opaque cap and a yellow, opaque body, size 17.5-18.5 mm, with a black print "LP" on the cap and "652" on the body, containing yellow to orange granules.

Sunitinib Medical Valley 50 mg is supplied in the form of hard capsules with a light brown, opaque cap and a light brown, opaque body, size 17.5-18.5 mm, with a white print "LP" on the cap and "653" on the body, containing yellow to orange granules.

The medicine is available in cardboard boxes containing blisters of 28 hard capsules in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB

Brädgårdsvägen 28

236 32 Höllviken

Sweden

Manufacturer/Importer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4

Sir Temi Zammit Buildings

SGN 3000 San Gwann

Malta

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

Iceland:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Sweden:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Denmark:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Norway:

Sunitinib Medical Valley 12.5/25/37.5/50 mg hard capsules

Poland:

Sunitinib Medical Valley

Date of last revision of the package leaflet:08/2024

Other sources of information

Detailed information on this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych.