SUNITINIB 12.5 mg Hard capsules

Зміст інструкції

1. Sunitinib Aurobindo 12,5 mg hard capsules, 25 mg hard capsules, 37,5 mg hard capsules, 50 mg hard capsules
   1. What is Sunitinib Aurobindo and what is it used for
   2. What you need to know before taking Sunitinib Aurobindo
2. Sunitinib Aurobindo may involve an increased risk of bleeding, changes in
   1. How to take Sunitinib Aurobindo
   2. Possible side effects
   3. How to store Sunitinib Aurobindo
   4. Package contents and other information

Sunitinib Aurobindo 12,5 mg hard capsules, 25 mg hard capsules, 37,5 mg hard capsules, 50 mg hard capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Sunitinib Aurobindo contains the active substance sunitinib, which is a protein kinase inhibitor. It is
used to treat cancer by preventing the activity of a specific group of proteins
that are known to be involved in the growth and spread of cancer cells.
Sunitinib Aurobindo is used to treat adults with the following types of cancer:

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestinal cancer, in cases where imatinib (another anticancer medicine) is no longer effective or can no longer be taken.
• 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 pancreatic cells that produce hormones) with disease progression or are inoperable.

If you have any doubts about the mechanism of action of Sunitinib Aurobindo or why this
medicine has been prescribed to you, please consult your doctor.

2. What you need to know before taking Sunitinib Aurobindo

Do not take Sunitinib Aurobindo

• if you are allergic to sunitinib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Sunitinib Aurobindo:

• If you have high blood pressure. Sunitinib Aurobindo may cause an increase in blood pressure. Your doctor may check your blood pressure during treatment with

Sunitinib Aurobindo and, if necessary, you may need to take medicines to lower your blood
pressure.

• If you have or have had blood disorders, bleeding problems or bruising.Treatment with

Sunitinib Aurobindo may involve an increased risk of bleeding, changes in

the number of certain blood cells whose deficiency causes anemia or affects the blood's ability to
coagulate. The risk of bleeding may be greater if you are taking warfarin or acenocoumarol, medications that thin the blood to prevent the formation of
blood clots. Tell your doctor if you experience any bleeding while taking
Sunitinib Aurobindo.

• If you have heart problems.Sunitinib Aurobindo can cause heart problems. Tell your doctor if you feel very tired, have shortness of breath, or have swelling in your feet and ankles.
• If you experience abnormal changes in heart rhythm.Sunitinib Aurobindo can cause changes in heart rhythm. During treatment with Sunitinib Aurobindo, your doctor may perform an electrocardiogram to assess the extent of these changes. Tell your doctor if, during treatment with Sunitinib Aurobindo, you feel dizzy, faint, or have irregular heartbeats.
• If you have recently had problems due to the formation of blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.Contact your doctor immediately if you experience symptoms such as tightness or pain in the chest, 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 during treatment with Sunitinib Aurobindo.
• If you have or have had an aneurysm(dilation and weakening of the wall of a blood vessel) or a rupture of the wall of a blood vessel.
• If you have or have had damage to the smaller blood vessels called thrombotic microangiopathy(TMA).Tell your doctor if you notice the appearance of fever, fatigue, tiredness, bruising, bleeding, swelling, mental confusion, vision loss, and seizures.
• If you have thyroid problems.Sunitinib Aurobindo can cause thyroid problems. Tell your doctor if you become more tired than usual while taking Sunitinib Aurobindo, generally feel colder than other people, or your voice becomes lower. Thyroid function must be checked before taking Sunitinib Aurobindo and regularly while you are taking the medication. If your thyroid does not produce enough thyroid hormone, you may need to take a thyroid hormone replacement.
• If you have or have had problems with the pancreas or gallbladder.Tell your doctor if you experience any of the following signs and symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.
• If you have or have had liver problems.Tell your doctor if you experience any of the following signs and symptoms of liver problems during treatment with Sunitinib Aurobindo: itching, yellowing of the skin or eyes, dark urine, and pain or discomfort in the upper right area of the stomach. Your doctor should perform blood tests to check liver function before and during treatment with Sunitinib Aurobindo, and as clinically appropriate.
• If you have or have had kidney problems.Your doctor will monitor kidney function.
• If you are about to undergo surgery or if you have had surgery recently.Sunitinib Aurobindo can affect how wounds heal. Usually, if you are about to

undergo surgery, you will need to stop treatment with Sunitinib Aurobindo. Your doctor
will decide when to start treatment with Sunitinib Aurobindo again.

• It is advisable to have a dental check-up before starting treatment with SunitinibAurobindo.
• If you have or have had pain in the mouth, teeth and/or jaw, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss, tell your doctor and dentist immediately.
• If you need to undergo invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sunitinib Aurobindo, especially if you are taking or have previously taken bisphosphonates intravenously. Bisphosphonates are medications used to prevent bone complications that may have been prescribed for another clinical problem.
• If you have or have had skin and subcutaneous tissue diseases.During treatment with this medication, “pyoderma gangrenosum” (painful skin ulceration) or “necrotizing fasciitis” (a skin/soft tissue infection that spreads rapidly and can be fatal) may occur. Contact your doctor immediately if you experience symptoms of infection around a skin wound, including fever, pain, redness, swelling, or drainage of pus or blood. This event is generally reversible after discontinuation of sunitinib. Serious skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use, which initially appear on the trunk as reddish spots in the shape of a target or circular patches, often with blisters in the center. The reaction may progress to widespread blistering or shedding of the skin, and can be fatal. If you develop a rash or any of these skin symptoms, consult a doctor immediately.
• If you have or have had seizures.Tell your doctor as soon as possible if you have high blood pressure, headache, or vision loss.
• If you have diabetes.Blood sugar levels should be checked regularly in diabetic patients to verify if the dosage of diabetes medications needs to be adjusted, in order to minimize the risk of low blood sugar levels. Tell your doctor as soon as possible if you notice signs and symptoms of reduced blood sugar levels (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents
Sunitinib Aurobindo is not indicated for patients under the age of 18 years.

Other medicines and Sunitinib Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those purchased without a prescription and those without a prescription.
Some medicines can change the levels of Sunitinib Aurobindo in the body. You should tell
your doctor if you are taking medicines that contain the following active ingredients:

• ketoconazole, itraconazole - used to treat fungal infections;
• erythromycin, clarithromycin, rifampicin - used to treat infections;
• ritonavir - used to treat AIDS;
• dexamethasone - a corticosteroid used for various conditions (such as allergic/respiratory disorders or skin diseases);
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions;
• herbal preparations containing St. John's Wort ( Hypericum perforatum) - used to treat depression and anxiety.

Sunitinib Aurobindo with food and drink
Consumption of grapefruit juice should be avoided during treatment with Sunitinib
Aurobindo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If pregnancy is possible, you should use a reliable contraceptive method during treatment with Sunitinib Aurobindo.
If you are breastfeeding, tell your doctor. You should not breastfeed during treatment with
Sunitinib Aurobindo.

Driving and operating machinery
If you experience dizziness or unusual fatigue, be particularly careful when driving or operating
machinery.

Sunitinib Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium
free’.

3. How to take Sunitinib Aurobindo

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.
The doctor will prescribe the appropriate dose for you, based on the type of cancer to be treated. If you are being
treated for:

• GIST or mRCC: the usual dose is 50 mg once a day to be taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (without medicine), in 6-week cycles.
• pNET: the usual dose is 37.5 mg once a day, without a rest period.

The doctor will determine the necessary dose for you and when to stop treatment with Sunitinib
Aurobindo.
Sunitinib Aurobindo can be taken with or without food.

If you take more Sunitinib Aurobindo than you should
If you accidentally took too many capsules, speak to your doctor immediately. You may need
medical assistance.

If you forget to take Sunitinib Aurobindo
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 these serious side effects (see also

What you need to know before taking Sunitinib Aurobindo):

Heart problems.Tell your doctor if you feel very tired, short of breath or have swollen feet and
ankles. These could be symptoms of heart problems such as heart failure and
problems with the heart muscle (cardiomyopathy).

Lung or breathing problems.Tell your doctor if you experience cough, chest pain,
sudden onset of shortness of breath or coughing up blood. These could
be symptoms of a pulmonary embolism, which occurs when blood clots reach the
lungs.

Kidney problems.Tell your doctor if you experience altered frequency of urination or no
urine output, which could be symptoms of kidney failure.

Bleeding.Tell your doctor if you experience any of the following symptoms or severe bleeding while taking Sunitinib Aurobindo: swollen, painful stomach (abdomen);
vomiting blood; dark, tarry stools; blood in your urine; headache or altered mental
state, coughing up blood or bloody sputum, coming from the lungs or
airways.

Tumor destruction causing perforation of the intestine.Tell your doctor if you have severe
abdominal pain, fever, nausea, vomiting, blood in your stools or changes in your bowel habits.
Other side effects that may occur with Sunitinib Aurobindo are:

Very common: may affect more than 1 in 10 people

• Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).
• Shortness of breath.
• High blood pressure.
• Excessive fatigue, loss of strength.
• Swelling caused by fluid retention under the skin and around the eyes, deep allergic rash.
• Mouth pain/irritation, mouth ulcers/inflammation/dryness, altered taste, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/bloating, loss/decrease of appetite.
• Reduced thyroid gland activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in the arms and legs.
• Yellowing of the skin/change in skin color, excessive skin pigmentation, change in hair color, rash on the palms of the hands and soles of the feet, skin rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient 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 retention, including around the lungs.
• Infections.
• Complications of serious infections (infection present in the bloodstream) that can cause tissue damage, organ failure and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in urine, sometimes leading to swelling.
• Flu-like syndrome.
• Altered blood tests, including liver and pancreatic enzyme levels.
• High uric acid levels in the blood.
• Hemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning or painful sensation in the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tearing.
• Altered skin sensation, itching, skin scaling and inflammation, blistering, acne, discoloration of nails, hair loss.
• Abnormal sensations in the extremities.
• Excessive reduction/increase in sensitivity, particularly to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Change in urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Soft tissue infections, including in the ano-genital region, potentially life-threatening (see section 2).
• Stroke.
• Heart attack caused by interrupted or reduced blood supply to the heart.
• Changes in the heart's electrical activity or altered heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumor destruction causing perforation of the intestine.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• Abnormal communication between two cavities of the body or with the skin.
• Mouth, tooth and/or jaw pain, swelling or ulcers in the mouth, numbness or heaviness in the jaw/maxilla, or tooth loss. These could be signs and symptoms of bone damage in the jaw/maxilla (osteonecrosis), see section 2.
• Overproduction of thyroid hormones with resulting increased metabolism.
• Problems with wound healing after surgery.
• Increased muscle enzyme in the blood (creatine phosphokinase).
• Inappropriate and excessive reaction to allergens, including hay fever, rash, skin itching, hives, localized swelling and difficulty breathing.
• Inflammation of the colon (colitis, ischemic colitis).

Rare: may affect up to 1 in 1,000 people

• Severe skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS) - TLS includes a set of metabolic complications that can occur during cancer treatment. They are caused by the breakdown products of cancer cells and can include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue associated with abnormal laboratory results (high levels of potassium, uric acid and phosphoric acid and low levels of calcium in the blood) that can lead to changes in kidney function and acute renal failure.
• Abnormal breakdown of muscles that can cause kidney problems (rhabdomyolysis).
• Changes in brain function that can lead to a variety of symptoms, such as headache, confusion, seizures and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to smaller blood vessels called thrombotic microangiopathy (TMA).

Not known (frequency cannot be estimated from available data):

• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections).
• Lack of energy, confusion, drowsiness, loss of consciousness/coma: these symptoms may be signs of brain toxicity caused by high levels of ammonia in the blood (hyperammonemic encephalopathy).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sunitinib Aurobindo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack and blister after “EXP.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sunitinib Aurobindo contains

• The active ingredient is sunitinib malate. Each capsule contains sunitinib malate, corresponding to 12.5 mg of sunitinib. Each capsule contains sunitinib malate, corresponding to 25 mg of sunitinib. Each capsule contains sunitinib malate, corresponding to 37.5 mg of sunitinib. Each capsule contains sunitinib malate, corresponding to 50 mg of sunitinib.
• The other ingredients are: Capsule contents: Mannitol, sodium croscarmellose, povidone (K-25), magnesium stearate.

Capsule shell: Titanium dioxide (E171), yellow iron oxide (E172) (for 25 mg and
50 mg), red iron oxide (E172), indigo carmine (E132) (for 25 mg, 37.5 mg and 50 mg),
gelatin.
Printing ink: Shellac (E904), titanium dioxide (E171) (for 12.5 mg and 25 mg), black iron oxide (E172) (for 37.5 mg and 50 mg), potassium hydroxide (E525).

Description of the appearance of Sunitinib Aurobindo and package contents
Hard capsules.

Sunitinib Aurobindo 12.5 mg hard capsules
Hard gelatin capsules with opaque red cap and opaque red body, size ‘4’, marked
with ‘S12.5’ with white ink on the body, filled with yellow/orange granules. The
approximate size of the capsule is about 14 mm.

Sunitinib Aurobindo 25 mg hard capsules
Hard gelatin capsules with opaque olive green cap and opaque red body, size ‘3’,
marked with ‘S25’ with white ink on the body, filled with yellow/orange granules. The approximate size of the capsule is about 16 mm.

Sunitinib Aurobindo 37.5 mg hard capsules
Hard gelatin capsules with opaque light green cap and opaque light green body, size ‘3’,
marked with ‘S37.5’ with white ink on the body, filled with yellow/orange granules. The approximate size of the capsule is about 16 mm.

Sunitinib Aurobindo 50 mg hard capsules
Hard gelatin capsules with opaque olive green cap and opaque olive green body, size ‘2’,
marked with ‘S50’ with white ink on the body, filled with yellow/orange granules. The approximate size of the capsule is about 18 mm.
Sunitinib Aurobindo 12.5 mg, 25 mg, 37.5 mg and 50 mg hard capsules are available in
blister packs.

Packs:

Blister packs: 30 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Eugia Pharma (Malta) Ltd
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914
Malta

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Sunitinib Aurobindo
Sweden: Sunitinib Eugia Pharma 12.5 mg/25 mg /37.5 mg/ 50 mg hard capsules