Sunitinib sandoz

Package leaflet: Information for the patient

Sunitinib Sandoz, 12.5 mg, hard capsules
Sunitinib Sandoz, 25 mg, hard capsules
Sunitinib Sandoz, 37.5 mg, hard capsules
Sunitinib Sandoz, 50 mg, hard capsules
Sunitinibum
Please 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 a specific individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Sunitinib Sandoz is and what it is used for
2. What you need to know before taking Sunitinib Sandoz
3. How to take Sunitinib Sandoz
4. Possible side effects
5. How to store Sunitinib Sandoz
6. Contents of the pack and other information

1. What Sunitinib Sandoz is and what it is used for

Sunitinib Sandoz contains the active substance sunitinib, a protein kinase inhibitor. This medicine is used in cancer treatment because it inhibits the activity of a specific group of proteins involved in the growth and spread of cancer cells.
Sunitinib Sandoz is used in adult patients for the treatment of the following tumours:

• gastrointestinal stromal tumour (GIST) – a type of stomach and intestinal tumour, when imatinib (another anticancer medicine) is ineffective 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 of hormone-producing cells in the pancreas that continue to grow or cannot be surgically removed.

If you have any questions about how Sunitinib Sandoz works or why your doctor has prescribed it, please consult your doctor.

2. Important information before using Sunitinib Sandoz

When not to use Sunitinib Sandoz
if the patient is allergic to sunitinib or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Before taking Sunitinib Sandoz, discuss with your doctor or pharmacist if:
the patient has high blood pressure. Sunitinib Sandoz may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Sandoz and, if necessary, prescribe antihypertensive medications.
the patient has or has had blood disorders, bleeding problems or bruising. Treatment with Sunitinib Sandoz may increase the risk of bleeding or cause changes in the number of certain blood cells, leading to anaemia or clotting disorders. If the patient is taking warfarin or acenocoumarol (anticoagulants used to prevent blood clots), the risk of bleeding is higher. If any bleeding occurs during treatment with Sunitinib Sandoz, inform your doctor immediately.
the patient has heart function disorders. Sunitinib Sandoz may cause heart-related problems. If the patient experiences severe fatigue, shortness of breath, or swelling of the feet and ankles, inform your doctor.
the patient has heart rhythm disorders. Sunitinib Sandoz may cause heart rhythm disturbances. Your doctor may order an electrocardiogram (ECG) during treatment to monitor these conditions. Seek medical advice immediately if you experience dizziness, fainting, or irregular heartbeat.
the patient has recently had problems related to blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism or thrombosis. If such symptoms occur during treatment with Sunitinib Sandoz—such as chest pain or pressure, pain in arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache or dizziness—seek immediate medical attention.
the patient has or has previously had an aneurysm (a weakened and bulging blood vessel wall) or a tear in the blood vessel wall.
the patient currently has or has previously had damage to the smallest blood vessels, known as thrombotic microangiopathy. If fever, fatigue, exhaustion, bruising, bleeding, swelling, confusion, vision loss or seizures occur, contact your doctor immediately.
the patient has thyroid function disorders. Sunitinib Sandoz may affect thyroid function. If during treatment the patient becomes easily fatigued, feels unusually cold or develops a hoarse voice, inform your doctor. Thyroid function should be checked before starting Sunitinib Sandoz and monitored regularly during treatment. Patients whose thyroid does not produce enough hormones may require hormone replacement therapy.
the patient has or has previously had disorders of the pancreas or gallbladder. Inform your doctor if the patient experiences any of the following symptoms: stomach pain (epigastric pain), nausea, vomiting and fever. These may be signs of pancreatitis or cholecystitis.
the patient has or has previously had liver function disorders. Inform your doctor if any of the following signs of liver problems occur during treatment with Sunitinib Sandoz: itching, yellowing of the eyes or skin (jaundice), dark-coloured urine, or pain or discomfort in the upper right part of the abdomen. Your doctor will order blood tests to monitor liver function before and during treatment, and whenever clinically indicated.
the patient has or has previously had kidney function disorders. Your doctor will monitor the patient's kidney function.
the patient is due to undergo surgery or has recently undergone surgery. Sunitinib Sandoz may affect wound healing. If the patient is scheduled for surgery, the doctor will usually advise stopping the medicine and will indicate when it can be resumed.
the patient has or has previously had skin and subcutaneous tissue disorders. During treatment with Sunitinib Sandoz, conditions such as "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (rapidly spreading, life-threatening subcutaneous tissue infection) may occur. Seek immediate medical attention if signs of wound infection appear, including fever, pain, redness, swelling or discharge of pus or blood. These effects usually resolve after discontinuation of sunitinib. Serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported during sunitinib treatment, initially presenting as red, target-like or circular skin lesions, often with central blisters. The rash may progress to widespread blistering or skin peeling, which may be life-threatening. If the patient develops a rash or any of these skin symptoms, seek immediate medical advice.
the patient has or has had seizures. If high blood pressure, headache or vision loss occurs, inform your doctor as soon as possible.
the patient has diabetes. Blood glucose levels should be monitored regularly in diabetic patients to determine whether a change in antidiabetic medication dose is needed to reduce the risk of hypoglycaemia. If symptoms of low blood sugar occur (fatigue, palpitations, sweating, hunger, loss of consciousness), seek medical advice immediately.
Before starting Sunitinib Sandoz, your doctor may recommend a dental check-up.
If the patient experiences or has experienced mouth pain, tooth, jaw or mandible pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw or mandible, or loose teeth, inform the treating doctor and dentist immediately.
If the patient requires invasive dental treatment or procedure, inform the dentist about taking Sunitinib Sandoz, especially if the patient is currently or has previously received intravenous bisphosphonates (medicines used to prevent bone complications and treat other conditions).
Children and adolescents
Sunitinib Sandoz is not recommended for patients under 18 years of age.
Sunitinib Sandoz with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the concentration of Sunitinib Sandoz in the body. If the patient is taking medicines containing any of the following active substances, inform your doctor:
ketoconazole, itraconazole (used to treat fungal infections)
erythromycin, clarithromycin, rifampicin (used to treat infections)
ritonavir (used to treat HIV infection)
dexamethasone (a corticosteroid used to treat various disorders such as allergies, respiratory conditions or skin diseases)
phenytoin, carbamazepine, phenobarbital (used to treat epilepsy and other neurological disorders)
herbal medicines containing St John's wort (Hypericum perforatum), used to treat depression and anxiety
Sunitinib Sandoz with food and drink
Do not drink grapefruit juice while taking Sunitinib Sandoz.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential should use effective contraception during treatment with Sunitinib Sandoz.
If the patient is breastfeeding, inform your doctor. Breastfeeding is not recommended during treatment with Sunitinib Sandoz.
Driving and using machines
Patients experiencing dizziness or unusual fatigue should exercise particular caution when driving or operating machinery.
Sunitinib Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Sunitinib Sandoz
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Your doctor will prescribe the appropriate dose depending on the type of tumour.

• Gastrointestinal stromal tumour (GIST) or metastatic renal cell carcinoma (MRCC): the usual dose is 50 mg taken once daily for 28 days (4 weeks), followed by a 14-day (2-week) treatment-free period, forming a 6-week cycle;
• Pancreatic neuroendocrine tumour (pNET): the usual dose is 37.5 mg once daily without a treatment-free period.

Your doctor will determine the appropriate dose for the patient and will advise whether and when to interrupt treatment with Sunitinib Sandoz.
The medicine can be taken with or without food.
Taking more than the recommended dose of Sunitinib Sandoz
If the patient accidentally takes too much Sunitinib Sandoz, seek immediate medical advice. Medical assistance may be required.
Missing a dose of Sunitinib Sandoz
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions, contact a doctor immediately (see also the section "Important information before taking Sunitinib Sandoz").

Heart problems: Inform the doctor if the patient experiences significant fatigue, shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart-related disorders, including heart failure and heart muscle disease (cardiomyopathy).

Lung or breathing problems: Inform the doctor if the patient develops cough, chest pain, sudden shortness of breath, or coughs up blood. These may be symptoms of a condition called "pulmonary embolism", which occurs when blood clots travel to the lungs.

Kidney function disorders: Inform the doctor if the patient experiences changes in frequency of urination or stops urinating altogether, as these may be symptoms of kidney failure.

Bleeding: Inform the doctor if, during treatment with Sunitinib Sandoz, the patient experiences any of the following symptoms or severe bleeding: abdominal pain and swelling; vomiting blood; black, sticky 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: Inform the doctor if the patient experiences severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.

Other adverse reactions during treatment with Sunitinib Sandoz 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 due to fluid accumulation under the skin and around the eyes, allergic rash
• Pain and/or irritation of the mouth, mouth ulcers, inflammation, dryness of the oral mucosa, taste disturbances, indigestion, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss or reduced appetite
• Reduced thyroid function (hypothyroidism)
• Dizziness
• Headache
• Nosebleeds
• Back pain, joint pain
• Pain in hands and feet
• Yellowing and/or discoloration of the skin, excessive skin pigmentation, hair color changes, rash on palms and soles, general rash, dry skin
• Cough
• Fever
• Difficulty falling asleep

Common: may affect up to 1 in 10 people:

• Formation of blood clots in blood vessels
• Inadequate blood supply to the heart muscle due to blockage or narrowing of the coronary arteries
• Chest pain
• Reduced amount of blood pumped by the heart
• Fluid accumulation, e.g. around the lungs
• Infections
• Complication of severe infection (blood infection), which may lead to tissue damage, organ failure, and death
• Low blood sugar levels (see section 2)
• Protein loss in urine, sometimes leading to oedema
• Flu-like symptoms
• Abnormal blood test results, including abnormal pancreatic and liver enzyme activity
• High levels of uric acid in the blood
• Haemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow
• Burning sensation or pain in the tongue, inflammation of the gastrointestinal mucosa, excessive gas in the stomach or intestine
• Weight loss
• Muscle and bone pain, muscle weakness, muscle fatigue, muscle pain, muscle cramps
• Dry nose, nasal mucosa congestion
• Excessive tearing
• Abnormal skin sensations, itching, skin peeling and inflammation, blister formation, acne, nail discoloration, hair loss
• Unusual sensations in the limbs
• Abnormally reduced or increased sensitivity, especially to touch
• Heartburn
• Dehydration
• Hot flushes
• Abnormal urine color
• Depression
• Chills

Uncommon: may affect up to 1 in 100 people:

• Life-threatening soft tissue infections, including in the genital and anal areas (see section 2)
• Stroke
• Myocardial infarction due to interrupted or reduced blood flow to the heart
• Changes in the heart's electrical function or irregular heartbeat
• Presence of fluid around the heart (pericardial effusion)
• Liver failure
• Abdominal pain due to pancreatitis
• Tumour lysis leading to intestinal perforation
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones
• Formation of an abnormal connection between one body cavity and another or with the skin (fistula)
• Mouth pain, tooth and/or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, tooth mobility. These may be symptoms of damage (necrosis) of the jaw and/or mandible (see section 2)
• Excessive production of thyroid hormones, leading to increased energy consumption by the body (increased resting metabolism)
• Impaired postoperative wound healing
• Increased activity of creatine kinase of muscle origin
• Severe allergic reaction, including hay fever, skin rash, skin itching, urticaria, swelling of certain body parts, and breathing difficulties
• Colitis (inflammation of the large intestine, ischemic colitis)

Rare: may affect up to 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 anticancer treatment. These complications are caused by the breakdown products of cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue combined with abnormal laboratory test results (high levels of potassium, uric acid, and phosphate, and low calcium levels in the blood), which may indicate kidney dysfunction and acute kidney failure
• Abnormal muscle breakdown, which may cause kidney problems (rhabdomyolysis)
• Abnormal changes in the brain that may cause a range of symptoms, including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome)
• Painful skin ulcers (pyoderma gangrenosum)
• Hepatitis
• Thyroiditis
• Damage to the smallest blood vessels (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 reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sunitinib Sandoz Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Do not use this medicine if the packaging is damaged or if there are signs of tampering with the closure.
Medicines must 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 Sandoz contains
The active substance is sunitinib.
Sunitinib Sandoz, 12.5 mg: Each capsule contains 12.5 mg of sunitinib.
Sunitinib Sandoz, 25 mg: Each capsule contains 25 mg of sunitinib.
Sunitinib Sandoz, 37.5 mg: Each capsule contains 37.5 mg of sunitinib.
Sunitinib Sandoz, 50 mg: Each capsule contains 50 mg of sunitinib.

The other ingredients are: microcrystalline cellulose, mannitol, sodium croscarmellose, povidone K30, magnesium stearate.

Sunitinib Sandoz, 12.5 mg

• Capsule shell: iron oxide red (E 172), titanium dioxide (E 171), gelatin
• Printing ink, white: shellac, titanium dioxide (E 171), propylene glycol

Sunitinib Sandoz, 25 mg

• Capsule shell: iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
• Printing ink, white: shellac, titanium dioxide (E 171), propylene glycol

Sunitinib Sandoz, 37.5 mg

• Capsule shell: iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
• Printing ink, black: shellac, iron oxide black (E 172), propylene glycol, ammonium hydroxide

Sunitinib Sandoz, 50 mg

• Capsule shell: iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
• Printing ink, white: shellac, titanium dioxide (E 171), propylene glycol

What Sunitinib Sandoz looks like and contents of the pack
Sunitinib Sandoz, 12.5 mg
Size 4 gelatin capsule with orange body and orange cap, white print “12.5 mg” on the body, containing granules of yellow to orange colour.

Sunitinib Sandoz, 25 mg
Size 3 gelatin capsule with caramel cap and orange body, white print “25 mg” on the body, containing granules of yellow to orange colour.

Sunitinib Sandoz, 37.5 mg
Size 2 gelatin capsule with yellow body and yellow cap, black print “37.5 mg” on the body, containing granules of yellow to orange colour.

Sunitinib Sandoz, 50 mg
Size 1 gelatin capsule with caramel body and caramel cap, white print “50 mg” on the body, containing granules of yellow to orange colour.

Pack sizes:
Blister packs containing 28 hard capsules, in cardboard boxes.
Perforated single-dose blisters containing 28 x 1 hard capsule, in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate,
3056 Limassol, Cyprus
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For further information about this medicinal product and its names in the countries of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00