Sunitinib ranbaxy

Package leaflet: Information for the user

Sunitinib Ranbaxy, 12.5 mg, hard capsules
Sunitinib Ranbaxy, 25 mg, hard capsules
Sunitinib Ranbaxy, 50 mg, hard capsules
Sunitinibum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents

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

Sunitinib Ranbaxy contains sunitinib as the active substance, which is a protein kinase inhibitor.
It is used in the treatment of certain cancers. It inhibits the activity of a specific group of proteins known
to be involved in the growth and spread of cancer cells.
Sunitinib Ranbaxy is used in the treatment of the following types of cancer in adults:

• Gastrointestinal stromal tumours (GIST), a type of stomach and intestinal tumour, when imatinib (another anticancer medicine) has stopped working or cannot be used;
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body;
• Progressive, unresectable pancreatic neuroendocrine tumours (pNET) (tumours arising from hormone-producing cells in the pancreas).

If you have any questions about how Sunitinib Ranbaxy works or why this medicine has been prescribed, please consult 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 Sunitinib Ranbaxy, discuss the following with your doctor:

• If the patient has high blood pressure. Sunitinib Ranbaxy may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sunitinib Ranbaxy, and you may need to be treated with medicines to lower blood pressure if necessary.

• If the patient has or has had blood disorders, bleeding or bruising. Treatment with Sunitinib Ranbaxy may increase the risk of bleeding or may cause changes in the number of certain blood cells, which could lead to anaemia or affect the blood’s ability to clot. If the patient is taking warfarin or acenocoumarol, anticoagulant medicines used to prevent blood clots, there may be an increased risk of bleeding. Inform your doctor about any bleeding episodes during treatment with Sunitinib Ranbaxy.

• If the patient has heart problems. Sunitinib Ranbaxy may cause heart-related issues. Inform your doctor if the patient experiences unusual fatigue, shortness of breath, or swelling in the feet or ankles.

• If the patient has or has had heart rhythm disorders. Sunitinib Ranbaxy may cause irregular heart rhythms. Your doctor may perform an electrocardiogram (ECG) during treatment to monitor for such disturbances. Inform your doctor if the patient experiences dizziness, fainting, or irregular heartbeat while taking Sunitinib Ranbaxy.

• If the patient has recently had venous or arterial thrombosis (types of blood vessel problems), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if, during treatment with Sunitinib Ranbaxy, the patient experiences symptoms such as chest pain or tightness, pain in the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness.

• If the patient has or has had an aneurysm (a weakened and bulging blood vessel wall) or a tear in the wall of a blood vessel.

• If the patient has or has had damage to the smallest blood vessels, known as thrombotic microangiopathy. Inform your doctor if the patient develops fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, or seizures.

• If the patient has or has had thyroid problems. Sunitinib Ranbaxy may affect the thyroid gland. Inform your doctor if the patient feels unusually tired, feels colder than usual, or has a hoarse voice during treatment with Sunitinib Ranbaxy. Your doctor should check thyroid function before starting treatment with Sunitinib Ranbaxy and regularly during treatment. If the thyroid gland does not produce enough hormone, the patient may require thyroid hormone replacement therapy.

• If the patient has or has had pancreas or gallbladder problems. Inform your doctor if the patient experiences any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, or fever. These may be signs of pancreatitis or gallbladder inflammation.

• If the patient has or has had liver problems. Inform your doctor if, during treatment with Sunitinib Ranbaxy, the patient develops any of the following signs of liver problems: itching, yellowing of the eyes or skin (jaundice), dark-coloured urine, or pain or discomfort in the upper right abdomen. Your doctor should order blood tests to monitor liver function before starting treatment with Sunitinib Ranbaxy, during treatment, and whenever clinically indicated.

• If the patient has or has had kidney problems. Your doctor will monitor kidney function.

• If the patient is scheduled for surgery or has recently undergone surgery. Sunitinib Ranbaxy may affect wound healing. The medicine is usually discontinued before surgery. Your doctor will decide when to restart Sunitinib Ranbaxy.

• The patient is advised to have a dental examination before starting treatment with Sunitinib Ranbaxy:

• If the patient experiences mouth pain, tooth or jaw pain, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth, inform the oncologist and dentist immediately.

• If the patient requires invasive dental treatment or oral surgery, inform the dentist about taking Sunitinib Ranbaxy, especially if the patient is currently or has previously received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone-related problems and may be used for other conditions.

• If the patient has or has had skin and subcutaneous tissue disorders. While taking this medicine, patients may develop pyoderma gangrenosum (painful skin ulcers) or necrotizing fasciitis (a rapidly spreading, life-threatening infection of the skin and/or soft tissues). Contact your doctor immediately if the patient develops signs of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These conditions usually resolve after stopping Sunitinib Ranbaxy. Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed during treatment. These reactions initially appear as red, target-shaped or circular spots, often with centrally located blisters. The rash may progress to extensive blistering or skin peeling and can be life-threatening. If the patient develops a rash or any of the above skin symptoms, seek medical advice immediately.

• If the patient has or has had seizures. Inform your doctor as soon as possible if the patient develops high blood pressure, headache, or vision loss.

• If the patient has diabetes. Blood glucose levels should be monitored regularly in diabetic patients to assess whether adjustment of antidiabetic medication is needed to minimize the risk of hypoglycaemia. Inform your doctor immediately if the patient experiences symptoms of low blood sugar (fatigue, palpitations, excessive sweating, hunger, or loss of consciousness).

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

Sunitinib Ranbaxy and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Some medicines may affect the concentration of Sunitinib Ranbaxy in the body. Inform your doctor if the patient is 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 infection,
• dexamethasone – a corticosteroid used in various diseases (such as allergic and/or respiratory disorders or skin conditions),
• 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.

Sunitinib Ranbaxy with food and drink
Do not drink grapefruit juice while taking Sunitinib Ranbaxy.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential should use an effective method of contraception during treatment with Sunitinib Ranbaxy.
Breastfeeding women should inform their doctor. Breastfeeding is not recommended during treatment with Sunitinib Ranbaxy.

Driving and using machines
If the patient experiences dizziness or significant fatigue, exercise particular caution when driving or operating machinery.

Sunitinib Ranbaxy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. it is considered "sodium-free".

3. How to take Sunitinib Ranbaxy

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Your doctor will prescribe the dose appropriate for you, depending on the type of tumour.
For patients being treated for:

• GIST or mRCC, the usual dose is 50 mg taken once daily for 28 days (4 weeks), followed by a 14-day (2-week) treatment-free interval (no medication), in 6-week treatment cycles.
• pNET, the usual dose is 37.5 mg taken once daily continuously.

Your doctor will determine the appropriate dose for you and when treatment with Sunitinib Ranbaxy should end.
Sunitinib Ranbaxy may be taken with or without food.
Taking more Sunitinib Ranbaxy than prescribed
If you take too many capsules, contact your doctor immediately.
Medical intervention may be necessary.
Missing a dose of Sunitinib Ranbaxy
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Contact a doctor immediately if the patient experiences any of the following adverse reactions (see also Important information before taking Sunitinib Ranbaxy):
Heart problems. Inform the doctor if the patient feels very tired, has 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 problems or breathing difficulties. 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 or absence of urination, which may be symptoms of kidney failure.
Bleeding. Inform the doctor if the patient experiences any of the following symptoms or severe bleeding while being treated with Sunitinib Ranbaxy: stomach (abdominal) 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.
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 function.

Other adverse reactions with Sunitinib Ranbaxy 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.
• Hypertension.
• Extreme fatigue, loss of strength.
• Swelling due to fluid accumulation under the skin and around the eyes, deep allergic rash.
• Pain and/or irritation in the mouth, painful ulceration and/or inflammation, and/or dryness of the mouth, taste disturbances, gastric disturbances, nausea, vomiting, diarrhoea, constipation, abdominal pain and/or swelling, loss of and/or reduced appetite.
• Reduced thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing of the skin and/or skin discoloration, excessive skin pigmentation, hair color changes, rash on palms and soles, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Inadequate blood supply to the heart due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention, including in the lung area.
• Infections.
• Complication following severe infection (blood infection) which may lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in urine, sometimes causing swelling.
• Pseudoinfluenza syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Haemorrhoids, rectal pain, bleeding from gums, difficulty swallowing or loss of swallowing ability.
• Burning sensation or pain in the tongue, inflammation of the mucous membrane of the gastrointestinal 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 mucous membrane, sensation of nasal congestion.
• Excessive tearing.
• Skin sensation disturbances, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Sensory disturbances in limbs.
• Disorders related to increased or decreased 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 the anogenital area (see section 2).

• Stroke.

• Myocardial infarction caused by interruption or reduction of blood supply to the heart.

• Changes in electrical function or heart rhythm disturbances.

• Presence of fluid around the heart (pericardial effusion).

• Liver failure.

• Abdominal pain caused by inflammation of the pancreas.

• Tumour lysis leading to intestinal perforation.

• Inflammation (swelling or redness) of the gallbladder with or without gallstones.

• Formation of abnormal connections between one body cavity and another or to the skin.

• Mouth pain, tooth and/or jaw pain, swelling or ulceration of the mouth, numbness or heaviness in the jaw, or loose teeth. These may be symptoms of jaw bone damage (osteonecrosis), see section 2.

• Excessive production of thyroid hormones leading to increased resting metabolism.

• Impaired healing of surgical wounds.

• Increased activity of muscle enzyme (creatine phosphokinase) in blood.

• Excessive reaction to allergens, including hay fever, skin rash, itching, hives, swelling of any body part, and breathing difficulties.

• Inflammation of the large intestine (colitis, 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 cancer treatment. These complications are caused by products released from dying tumour cells and may include: nausea, shortness of breath, irregular heartbeat, muscle spasms, seizures, cloudy urine, and fatigue associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphate, and low calcium levels in blood), which may lead to kidney changes and acute kidney failure.
• Abnormal muscle breakdown which may cause kidney disease (rhabdomyolysis).
• Abnormal changes in the brain which may cause a syndrome of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Hepatitis.
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels called thrombotic microangiopathy.

Frequency not known (frequency cannot be estimated from available data)

• Enlargement and weakening of a 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 effects occur, including any not listed in this leaflet, inform a 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated month.
• No special storage conditions apply.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of prior opening.

Medicines must not be disposed of via the sewage system 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 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.
Other ingredients are:

• Capsule contents: mannitol, sodium croscarmellose, povidone (K-30), and magnesium stearate.
• Capsule shell: titanium dioxide (E 171), gelatin, red iron oxide (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.
Other ingredients are:

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

Sunitinib Ranbaxy 50 mg hard capsules
The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to
50 mg of sunitinib.
Other ingredients are:

• Capsule contents: mannitol, sodium croscarmellose, povidone (K-30), and magnesium stearate.
• Capsule shell: titanium dioxide (E 171), gelatin, yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (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 as hard, self-sealing gelatin capsules with an opaque red-brown cap and an opaque red-brown body, printed in white with "RM53" on the cap and "RM53" on the body, containing a yellow to orange powder.
Sunitinib Ranbaxy 25 mg is available as hard, self-sealing gelatin capsules with an opaque caramel cap and an opaque red-brown body, printed in white with "RM54" on the cap and "RM54" on the body, containing a yellow to orange powder.
Sunitinib Ranbaxy 50 mg is available as hard, self-sealing gelatin capsules with an opaque caramel cap and an opaque caramel body, printed in white with "RM56" on the cap and "RM56" on the body, containing a yellow to orange powder.

Blister packs
The medicine is available in PVC/PCTFE/Aluminium foil blisters containing 28 hard capsules, in a cardboard box.

HDPE bottle
The medicine is available in HDPE bottles with a PP screw cap and an induction-sealed liner, containing 28 or 30 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Poland

Manufacturer/Importer
Sun Pharmaceuticals Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia S.A.
Strada Fabriciei Nr 124
400640 Cluj-Napoca
Romania