Sunitinib Ranbaxi

Leaflet accompanying the packaging: information for the user

Sunitinib Ranbaxy, 12.5 mg, hard capsules

Sunitinib Ranbaxy, 25 mg, hard capsules

Sunitinib Ranbaxy, 37.5 mg, hard capsules

Sunitinib Ranbaxy, 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. See section 4.

Table of contents of the leaflet

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

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

Sunitinib Ranbaxy contains the active substance sunitinib, which is a protein kinase inhibitor.
It is used to treat cancer. It works by blocking the activity of a special group of proteins, known to be involved in the growth and spread of cancer cells.
Sunitinib Ranbaxy is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumors (GISTs), a type of stomach and intestine cancer, when imatinib (another anticancer drug) 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 Ranbaxy works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Sunitinib Ranbaxy

When not to take Sunitinib Ranbaxy:

• 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 Sunitinib Ranbaxy, discuss with your doctor:

• if you have high blood pressure. Sunitinib Ranbaxy may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib Ranbaxy, and you may need to be treated with blood pressure-lowering medicines.
• if you have or have had blood disorders, bleeding, or bruising. Treatment with Sunitinib Ranbaxy 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 Ranbaxy.
• if you have heart problems. Sunitinib Ranbaxy may cause heart problems. Tell your doctor if you experience fatigue, shortness of breath, or swelling of the feet or ankles.
• if you have irregular heart rhythms. Sunitinib Ranbaxy may cause irregular heart rhythms. During treatment with Sunitinib Ranbaxy, your doctor may perform an electrocardiogram to assess these irregularities. Tell your doctor if you experience dizziness, fainting, or irregular heart rhythms while taking Sunitinib Ranbaxy.
• if you have recently had problems with blood clots in the veins and/or arteries (a type of blood vessel), 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, 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 damage to the smallest blood vessels called thrombotic microangiopathy. Tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, loss of vision, or seizures.
• if you have thyroid problems. Sunitinib Ranbaxy may cause thyroid problems. Tell your doctor if you experience fatigue, feel colder than others, or have a hoarse voice while taking Sunitinib Ranbaxy. Your doctor should check your thyroid function before starting treatment with Sunitinib Ranbaxy 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 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 Ranbaxy, during treatment, and if there are clinical signs.

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 Ranbaxy, during treatment, and if there are clinical signs.

• if you have or have had kidney problems. Your doctor will monitor your kidney function.
• if you are going to have surgery or have recently had surgery. Sunitinib Ranbaxy may affect wound healing. The medicine is usually stopped in patients before surgery. Your doctor will decide when to restart Sunitinib Ranbaxy.
• a dental examination is recommended before starting treatment with Sunitinib Ranbaxy:
• -if you experience pain in the mouth, tooth, or jaw, swelling, or ulcers in the mouth, numbness, or a feeling of heaviness in the jaw, or tooth mobility, tell your oncologist and dentist immediately.
• -if you need invasive dental treatment or oral surgery, you should inform your dentist that you are taking Sunitinib Ranbaxy, 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 ulcers) or necrotizing fasciitis (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening) may occur. You should 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 treatment with Sunitinib Ranbaxy. During treatment with this medicine, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened 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, you should 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, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

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

Sunitinib Ranbaxy and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and those planned to be taken.
Some medicines may affect the levels of Sunitinib Ranbaxy in your body. Tell your doctor if you are taking medicines containing the following active substances:

• ketokonazole, 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.

Taking Sunitinib Ranbaxy with food and drink

Do not drink grapefruit juice while taking Sunitinib Ranbaxy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitinib Ranbaxy.
Women who are breastfeeding should inform their doctor. Do not breastfeed while taking Sunitinib Ranbaxy.

Driving and using machines

If you experience dizziness or significant fatigue, be careful when driving or operating machinery.

Sunitinib Ranbaxy contains sodium

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

3. How to take Sunitinib Ranbaxy

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 taking Sunitinib Ranbaxy.
Sunitinib Ranbaxy can be taken with or without food.

Taking more Sunitinib Ranbaxy than prescribed

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

Missing a dose of Sunitinib Ranbaxy

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 side effects (see also Important information before taking Sunitinib Ranbaxy):
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 travel to the lungs.
Kidney problems. Tell your doctor if you experience changes in urination frequency or absence of urination, which may be a sign of kidney failure.
Bleeding. Tell your doctor if you experience any of the following symptoms or severe bleeding during treatment with Sunitinib Ranbaxy: 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.
Tumor lysis syndrome leading to intestinal 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 Ranbaxy 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 caused by fluid accumulation under the skin and around the eyes, allergic rash, deep rash.
• Pain and/or irritation in the mouth, painful ulcers and/or inflammation, and/or dryness of the mouth, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain and/or swelling, loss of and/or decreased appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing of the skin and/or discoloration, excessive skin pigmentation, hair color changes, rash on the palms and soles, 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 amount of blood pumped by the heart.
• Fluid accumulation, including in the lungs.
• Infections.
• A complication after a severe infection (sepsis), which can cause tissue damage, organ failure, and death.
• Low 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 pain, muscle cramps.
• Dryness of the nasal mucosa, feeling of nasal congestion, excessive tearing.
• Skin sensation disturbances, itching, skin peeling, and inflammation, blisters, acne, nail discoloration, hair loss.
• Skin sensation disturbances in the limbs.
• Sensation disturbances related to 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 (abdominal 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.
• Pain in the mouth, tooth, or jaw, swelling, or ulcers in the mouth, numbness, 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.
• Abnormal 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 1000 people

• Severe skin and mucous membrane reaction (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 may include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, lack of 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 changes 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, disorientation, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged smallest blood vessels called 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 signs of a toxic effect of high blood ammonia levels on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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, you can help provide more information on the safety of this medicine.

5. How to store Sunitinib Ranbaxy

• 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 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib Ranbaxy contains

Sunitinib Ranbaxy, 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:mannitol, sodium croscarmellose, povidone (K-30), and magnesium stearate.
• Capsule shell:titanium dioxide (E 171), gelatin, iron oxide red (E 172)
• Printing ink:shellac, propylene glycol, titanium dioxide (E 171), potassium hydroxide.

Sunitinib Ranbaxy, 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:mannitol, sodium croscarmellose, povidone (K-30), and magnesium stearate.
• Capsule shell:titanium dioxide (E 171), gelatin, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).
• Printing ink:shellac, propylene glycol, titanium dioxide (E 171), potassium hydroxide.

Sunitinib Ranbaxy, 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:mannitol, sodium croscarmellose, povidone (K-30), and magnesium stearate.
• Capsule shell:titanium dioxide (E 171), gelatin, iron oxide yellow (E 172).
• Printing ink:shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172).

Sunitinib Ranbaxy, 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:mannitol, sodium croscarmellose, povidone (K-30), and magnesium stearate.
• Capsule shell:titanium dioxide (E 171), gelatin, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).
• Printing ink:shellac, propylene glycol, titanium dioxide (E 171), potassium hydroxide.

What Sunitinib Ranbaxy looks like and contents of the pack

Sunitinib Ranbaxy 12.5 mg is available in self-locking, hard gelatin capsules with a reddish-brown cap and reddish-brown body, with white printing "RM53" on the cap and "RM53" on the body, containing a yellow to orange powder.
Sunitinib Ranbaxy 25 mg is available in hard, self-locking gelatin capsules with a caramel cap and reddish-brown body, with white printing "RM54" on the cap and "RM54" on the body, containing a yellow to orange powder.
Sunitinib Ranbaxy 37.5 mg is available in hard, self-locking gelatin capsules with a yellow cap and yellow body, with black printing "RM55" on the cap and "RM55" on the body, containing a yellow to orange powder.
Sunitinib Ranbaxy 50 mg is available in hard, self-locking gelatin capsules with a caramel cap and caramel body, with white printing "RM56" on the cap and "RM56" on the body, containing a yellow to orange powder.
Blister packs:
The medicine is available in blisters made of PCV/PCTFE/Aluminum foil containing 28 hard capsules in a cardboard box.
HDPE bottle
The medicine is available in HDPE bottles with a PP cap and an induction seal containing 28 and 30 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw

Manufacturer/Importer

Sun Pharmaceuticals Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
Strada Fabricii Nr 124
400632 Cluj-Napoca
Romania
Date of last revision of the leaflet:27.06.2024