Sunitinib Sandoz

Leaflet attached to the packaging: patient information

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

Sunitinib

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Sunitinib Sandoz and what is it used for
• 2. Important information before taking Sunitinib Sandoz
• 3. How to take Sunitinib Sandoz
• 4. Possible side effects
• 5. How to store Sunitinib Sandoz
• 6. Package contents and other information

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

Sunitinib Sandoz contains the active substance sunitinib, a protein kinase inhibitor. The medicine is used to treat cancer, as it inhibits the activity of a specific group of proteins involved in the growth and spread of cancer cells.

Sunitinib Sandoz is used in adults to treat the following cancers:

• gastrointestinal stromal tumor (GIST) - a type of stomach and intestine cancer, 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 tumors (pNET) - tumors of the hormone-producing cells of the pancreas that continue to grow or cannot be surgically removed.

If the patient has any questions about how Sunitinib Sandoz works or why their doctor has prescribed it, they should consult their doctor.

2. Important information before taking Sunitinib Sandoz

When not to take Sunitinib Sandoz

if the patient is allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Sunitinib Sandoz, the patient should discuss with their doctor or pharmacist if:

the patient has high blood pressure. Sunitinib Sandoz may cause an increase in blood pressure. The doctor may monitor the patient's blood pressure while taking Sunitinib Sandoz and, if necessary, prescribe antihypertensive drugs.

the patient has or has had a blood disorder, bleeding or bruising. Taking Sunitinib Sandoz may increase the risk of bleeding or change the number of certain blood cells, leading to anemia or blood clotting disorders. If the patient is taking warfarin or acenocoumarol (blood-thinning medicines to prevent blood clots), the risk of bleeding is higher. If the patient experiences any bleeding while taking Sunitinib Sandoz, they should tell their doctor.

the patient has heart problems. Sunitinib Sandoz may cause heart problems. If the patient experiences severe fatigue, shortness of breath, or swelling of the feet and ankles, they should consult their doctor.

the patient has heart rhythm disorders. Sunitinib Sandoz may cause heart rhythm disorders. The doctor may order an electrocardiogram (ECG) while taking this medicine to assess these disorders. If the patient experiences dizziness, fainting, or abnormal heart function, they should consult their doctor.

the patient has recently had problems with blood clots in the veins and/or arteries (a type of blood vessel), including stroke, heart attack, embolism, or thrombosis. If the patient experiences 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, they should consult their doctor immediately.

the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

the patient currently has or has had damage to the smallest blood vessels, known as thrombotic microangiopathy. If the patient experiences fever, fatigue, exhaustion, bruising, bleeding, swelling, confusion, loss of vision, and seizures, they should consult their doctor.

the patient has thyroid problems. Sunitinib Sandoz may cause thyroid problems. If the patient becomes easily tired, feels colder than others, or has a deepening of their voice, they should tell their doctor. The patient's thyroid function should be checked before starting Sunitinib Sandoz and regularly monitored during treatment. Patients whose thyroid does not produce enough hormones may receive these hormones as replacement therapy.

the patient has or has had pancreatic or gallbladder problems. The patient should consult their doctor if they experience any of the following symptoms: stomach pain (abdominal pain), nausea, vomiting, and fever. These may be caused by pancreatitis or gallbladder inflammation.

the patient has or has had liver problems. The patient should tell their doctor if they experience any of the following symptoms of liver problems: itching, yellowing of the eyes or skin, dark urine, and pain or discomfort in the upper right abdomen. The doctor will order blood tests to check liver function before and during treatment with this medicine, as well as when clinically indicated.

the patient has or has had kidney problems. The doctor will monitor the patient's kidney function.

the patient is going to have surgery or has recently had surgery. Sunitinib Sandoz may affect wound healing. If the patient is going to have surgery, the doctor will usually advise them to stop taking this medicine and decide when to resume it.

the patient has or has had skin and subcutaneous tissue disorders. During treatment with Sunitinib Sandoz, it is possible to experience "pyoderma gangrenosum" (painful skin ulcers) or "necrotizing fasciitis" (a rapidly spreading infection of the tissue under the skin that can be life-threatening). The patient should immediately consult their doctor if they experience symptoms of wound infection, including fever, pain, redness, swelling, or the appearance of pus or blood. This reaction usually resolves after discontinuation of sunitinib. During treatment with sunitinib, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported, initially as red spots resembling targets or circular spots on the torso, often with centrally located blisters. The rash can progress to forms with extensive blisters or skin peeling, which can be life-threatening. If the patient experiences a rash or the mentioned skin symptoms, they should immediately consult their doctor.

the patient has or has had seizures. If the patient experiences high blood pressure, headache, or vision loss, they should inform their doctor as soon as possible.

the patient has diabetes. In patients with diabetes, blood sugar levels should be regularly monitored to determine if a change in the dose of the anti-diabetic medicine is needed to reduce the risk of hypoglycemia. If the patient experiences any symptoms of hypoglycemia (fatigue, palpitations, sweating, hunger, and loss of consciousness), they should immediately consult their doctor.

Before starting Sunitinib Sandoz, the doctor may recommend a dental check-up.

If the patient experiences or has experienced mouth pain, toothache, jaw and/or facial pain, swelling, or ulcers in the mouth, numbness or heaviness of the jaw and/or face, or loose teeth, they should immediately inform their doctor and dentist.

If the patient needs to undergo invasive treatment or dental surgery, they should tell their dentist about taking Sunitinib Sandoz, especially if they are also taking or have taken bisphosphonates (medicines used to prevent bone complications and treat other conditions) intravenously.

Children and adolescents

Sunitinib Sandoz should not be used in patients under 18 years of age.

Sunitinib Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Some medicines may affect the levels of Sunitinib Sandoz in the body. If the patient is taking medicines containing the following active substances, they should inform their doctor:

ketokonazole, itraconazole (medicines used to treat fungal infections)

erythromycin, clarithromycin, rifampicin (medicines used to treat infections)

ritonavir (a medicine used to treat HIV infection)

dexamethasone (a corticosteroid used to treat various conditions, such as allergies, respiratory disorders, or skin diseases)

phenytoin, carbamazepine, phenobarbital (medicines 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

While taking Sunitinib Sandoz, the patient should not drink grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Women of childbearing age should use effective methods of contraception while taking Sunitinib Sandoz.

If the patient is breastfeeding, they should inform their doctor. While taking Sunitinib Sandoz, the patient should not breastfeed.

Driving and using machines

Patients who experience dizziness or unusual fatigue should be cautious when driving or operating machines.

Sunitinib Sandoz contains sodium

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

3. How to take Sunitinib Sandoz

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The doctor will prescribe the appropriate dose of Sunitinib Sandoz for the patient, depending on the type of cancer.

• gastrointestinal stromal tumor (GIST) or metastatic renal cell carcinoma (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 taking the medicine), which forms a 6-week cycle;
• pancreatic neuroendocrine tumor (pNET): the usual dose is 37.5 mg taken once a day, without a break.

The doctor will determine the dose suitable for the patient and decide if and when to stop taking Sunitinib Sandoz.

The medicine can be taken with or without food.

Taking a higher dose of Sunitinib Sandoz than recommended

If the patient accidentally takes too much Sunitinib Sandoz, they should immediately consult their doctor. Medical attention may be necessary.

Missing a dose of Sunitinib Sandoz

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

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should immediately consult their doctor (see also "Important information before taking Sunitinib Sandoz").

Heart problems. The patient should tell their doctor if they experience severe fatigue, shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, including heart failure and cardiomyopathy (heart muscle disease).

Lung or breathing problems. The patient should tell their doctor if they 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 problems. The patient should tell their doctor if they experience changes in the frequency of urination or if they do not urinate, as these may be symptoms of kidney failure.

Bleeding. The patient should tell their doctor if they experience any of the following symptoms or severe bleeding: 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 intestinal perforation. The patient should tell their doctor if they experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements.

Other side effects that may occur during treatment with Sunitinib Sandoz include:

Very common: may occur in 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, loss of strength

swelling due to fluid accumulation under the skin and around the eyes, allergic rash

mouth pain and/or irritation, ulcers, inflammation, dryness of the mouth mucosa, taste disorders, nausea, vomiting, diarrhea, constipation, stomach pain and/or swelling, loss of appetite

decreased thyroid function (hypothyroidism)

dizziness

headache

nosebleeds

back pain, joint pain

arm and leg pain

yellowing and/or discoloration of the skin, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin

cough

fever

sleeping difficulties

Common: may occur in up to 1 in 10 people:

blood clots in blood vessels

insufficient blood flow to the heart muscle due to blockage or narrowing of the coronary arteries

chest pain

decreased amount of blood pumped by the heart

fluid accumulation, e.g., around the lungs

infections

severe infection complication (sepsis), which can lead to tissue damage, organ failure, and death

low blood sugar levels (see section 2)

protein loss in the urine, which can sometimes lead to swelling

flu-like symptoms

abnormal blood test results, including abnormal activity of pancreatic and liver enzymes

high levels of uric acid in the blood

hemorrhoids, anal pain, gum bleeding, difficulty swallowing or inability to swallow

In rare cases, the following side effects may occur:

Rare: may occur in up to 1 in 1000 people:

life-threatening infection of soft tissues, including the genital and anal areas

stroke

heart attack due to interrupted or reduced blood flow to the heart

changes in heart electrical activity or abnormal heart rhythm

fluid accumulation around the heart (pericardial effusion)

liver failure

stomach pain due to pancreatitis

tumor lysis syndrome leading to intestinal perforation

inflammation 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, toothache, and/or jaw pain, swelling, or ulcers in the mouth, numbness or heaviness of the jaw, loose teeth. These may be symptoms of jaw and/or facial bone damage (osteonecrosis) (see section 2)

excessive production of thyroid hormones, leading to increased energy expenditure by the body at rest

wound healing disorders after surgery

increased activity of the muscle enzyme creatine kinase

allergic reaction, including hay fever, skin rash, itching, hives, swelling of certain body parts, and breathing difficulties

inflammation of the colon (colitis, ischemic colitis)

Very rare: may occur in up to 1 in 10,000 people:

severe skin reaction involving the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)

tumor lysis syndrome - a group of metabolic complications that can occur during anticancer treatment. These complications are caused by the breakdown products of cancer cells and may include nausea, shortness of breath, irregular heart function, muscle cramps, seizures, cloudy urine, and fatigue, along with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which may indicate kidney problems and acute kidney failure

abnormal muscle breakdown, which can cause kidney problems (rhabdomyolysis)

abnormal brain changes, which can 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 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, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be a sign of the toxic effect of high blood ammonia levels on the brain (hyperammonemic encephalopathy).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sunitinib Sandoz

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 the medicine if the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Sunitinib Sandoz contains

The active substance of the medicine 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: red iron oxide (E 172), titanium dioxide (E 171), gelatin
• White printing ink: shellac, titanium dioxide (E 171), propylene glycol Sunitinib Sandoz, 25 mg
• Capsule shell: black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
• White printing ink: shellac, titanium dioxide (E 171), propylene glycol Sunitinib Sandoz, 37.5 mg
• Capsule shell: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
• Black printing ink: shellac, black iron oxide (E 172), propylene glycol, ammonium hydroxide Sunitinib Sandoz, 25 mg
• Capsule shell: black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
• White printing ink: shellac, titanium dioxide (E 171), propylene glycol

Sunitinib Sandoz, 50 mg

What Sunitinib Sandoz looks like and contents of the pack

Sunitinib Sandoz, 12.5 mg

Orange-colored capsule, size 4, with a white imprint "12.5 mg" on the body, containing yellow to orange granules.

Sunitinib Sandoz, 25 mg

Caramel-colored capsule, size 3, with a white imprint "25 mg" on the body, containing yellow to orange granules.

Sunitinib Sandoz, 37.5 mg

Yellow-colored capsule, size 2, with a black imprint "37.5 mg" on the body, containing yellow to orange granules.

Sunitinib Sandoz, 50 mg

Caramel-colored capsule, size 1, with a white imprint "50 mg" on the body, containing yellow to orange granules.

Package sizes:

Blisters containing 28 hard capsules, in cardboard boxes.

Perforated unit dose blisters containing 28 x 1 hard capsule, in cardboard boxes.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 more information about this medicine and its authorized names in the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of last revision of the leaflet:06/2024

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