Prospecto:Information for the User

Sunitinib Dr. Reddys 12.5 mg Hard Capsules EFG

Sunitinib Dr. Reddys 25 mg Hard Capsules EFG

Sunitinib Dr. Reddys 50 mg Hard Capsules EFG

sunitinib

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor,evenif they are not listed in this prospectus. See section 4.

1.What is Sunitinib Dr. Reddys and for what it is used

2.What you need to knowbeforestarting totake Sunitinib Dr. Reddys

3.How to take Sunitinib Dr. Reddys

4.Possible adverse effects

5Storage of Sunitinib Dr. Reddys

6.Contents of the package and additional information

Sunitinib Dr. Reddys contains the active ingredient sunitinib, which is a protein-tyrosine kinase inhibitor. It is used for the treatment of cancer and acts by preventing the activity of a specific group of proteins involved in the growth and proliferation of cancer cells.

Sunitinib is used to treat adults with the following types of cancer:

-Gastrointestinal stromal tumor (GIST), a type of stomach and intestinal cancer, when imatinib (another anticancer medication) has failed or cannot 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 hormone-secreting cells in the pancreas) that have progressed or cannot be removed with surgery.

If you have any doubts about how Sunitinib Dr. Reddys works or why this medication has been prescribed for you, consult your doctor.

Do not take Sunitinib Dr. Reddys:

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

Warnings and precautions

Consult your doctor before starting to take Sunitinib Dr. Reddys:

• If you have high blood pressure. Sunitinib may increase blood pressure. Your doctor may monitor your blood pressure during treatment with this medicine, and if necessary, you may be treated with medicines that reduce blood pressure.

• If you have or have had blood disorders, bleeding problems or bruising. Treatment with sunitinib may lead to a high risk of bleeding or produce changes in the number of certain blood cells, which may cause anemia or affect blood clotting. If you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent clots, there may be a greater risk of bleeding. If you experience any bleeding during treatment with this medicine, consult your doctor.

• If you have heart problems. Sunitinib may cause heart problems. Consult your doctor if you feel very tired, short of breath or if you have swollen feet and ankles.

• If you have abnormal heart rhythm changes. Sunitinib may cause abnormal heart rhythm changes. Your doctor may obtain electrocardiograms to evaluate these problems during treatment with sunitinib. Consult your doctor if you experience dizziness, weakness or abnormal heartbeats during treatment with this medicine.

• If you have had recent blood clots in 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 chest pain or pressure, pain in the arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of the body, speech problems, headache or dizziness while being treated with sunitinib.

• If you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or rupture of the wall of a blood vessel.

• If you have or have had damage to smaller blood vessels known as microangiopathic thrombosis (MAT). Contact your doctor if you experience fever, fatigue, tiredness, bruises, bleeding, swelling, confusion, loss of vision and seizures.

• If you have thyroid problems. Sunitinib may cause thyroid problems. Contact your doctor if you feel tired more easily, are usually colder than others or your voice becomes deeper while taking sunitinib. Before starting treatment with this medicine, your thyroid function should be checked and monitored periodically while taking it. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement.

-If you have or have had pancreatic disorders or gallbladder problems. Contact your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdominal area), nausea, vomiting and fever. These may be caused by inflammation of the pancreas or gallbladder.

• If you have or have had liver problems. Contact your doctor if you develop any of the following signs and symptoms of liver problems during treatment with sunitinib: itching, yellow eyes or skin, dark urine and pain or discomfort in the upper right abdominal area. Your doctor should perform blood tests to monitor liver function before and during treatment with this medicine, as well as when clinically indicated.

• If you have or have had kidney problems. Your doctor will monitor your renal function.

• If you are to undergo surgery or have had a recent operation. Sunitinib Dr. Reddys may affect wound healing. If you are to undergo surgery, you will usually stop taking sunitinib. Your doctor will decide when to start taking this medicine again.

• Before starting treatment with sunitinib, you may be advised to have a dental review

• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, you may develop "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (infection of the skin/soft tissues that spreads quickly and can be fatal). Contact your doctor immediately if you experience symptoms of infection around a skin lesion, such as fever, pain, redness, swelling or discharge of pus or blood. This reaction is usually reversible after stopping sunitinib. Cases of severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported, which initially appeared as red target-like spots or circular spots, often accompanied by central blisters on the trunk. This rash may progress to form widespread blisters or cause skin peeling, and may be life-threatening. Consult your doctor immediately if you develop a skin rash or the indicated skin symptoms.

• If you have or have had seizures. If you have high blood pressure, headache or loss of vision, notify your doctor as soon as possible.

• If you have diabetes. Regular blood glucose level checks should be performed in diabetic patients to assess whether the dose of antidiabetic medication needs to be adjusted to minimize the risk of hypoglycemia. Inform your doctor as soon as possible if you experience signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).

Children and adolescents

Sunitinib Dr. Reddys is not recommended for use in patients under 18 years of age.

Other medicines and Sunitinib Dr. Reddys

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those obtained without a prescription.

Some medicines may affect the levels of sunitinib in your body. You should inform your doctor if you are taking medicines that contain any of the following active ingredients:

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

Taking Sunitinib Dr. Reddys with food and drinks

You should avoid taking grapefruit juice while being treated with sunitinib.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

If you can become pregnant, you should use a reliable contraceptive method during treatment with sunitinib.

If you are breastfeeding, inform your doctor. You should not breastfeed your child during treatment with sunitinib.

Driving and operating machinery

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

Sunitinib Dr. Reddys contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will establish the correct dose depending on the type of cancer to be treated.

• For GIST or CCRM: the usual dose is 50 mg once a day for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medication) in 6-week cycles.
• For pNET: the usual dose is 37.5 mg once a day without a rest period.

Your doctor will indicate the suitable dose you need to take, as well as whether you need to suspend treatment with sunitinib and when.

Sunitinib Dr. Reddys can be taken with or without food.

How to open the desiccant blister

To open the blisters, separate a dose from the blister using the perforated lines. Then, peel off the blister film and remove the capsule. Do not push the capsule through the film as this could damage the capsule.

If you take more Sunitinib Dr. Reddys than you should

If you have accidentally taken too many capsules, consult your doctor immediately. You may require medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Sunitinib Dr. Reddys

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should contact your doctor immediately if you experience any of the following serious side effects (also see What you need to know before starting to take Sunitinib Dr. Reddys):

• Heart problems. Consult your doctor if you are very tired, short of breath, or have swollen feet and ankles. These may be symptoms of heart problems that can include heart failure and heart muscle problems (cardiomyopathy).

• Lung or respiratory problems. Consult your doctor if you develop a cough, chest pain, sudden difficulty breathing, or cough up blood. These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to the lungs.

• Kidney problems. Consult your doctor if you experience a change in urine frequency or absence of urine, as these may be symptoms of kidney failure.

• Bleeding. Consult your doctor if you have any of these symptoms or a severe bleeding problem during sunitinib treatment: stomach (abdomen) pain or swelling; vomit blood; have black, sticky stools; urinate with blood; have a headache or any change in mental state; cough up blood or have bloody sputum from the lungs or respiratory tract.

• Tumor destruction causing a perforation in the intestine. Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other side effects with sunitinib may include:

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).

•Difficulty breathing.

•High blood pressure.

•Extreme fatigue, loss of strength.

•Fast swelling of tissues caused by fluid under the skin and around the eye, severe allergic reaction.

•Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/decrease of appetite.

•Decreased activity of the thyroid gland (hypothyroidism).

•Dizziness.

•Headache.

•Nosebleed.

•Back pain, joint pain.

•Arm and leg pain.

•Yellow skin/decoloration of the skin, excessive skin pigmentation, change in hair color, skin rash on the palms of the hands and soles of the feet, rash, dry skin.

•Cough.

•Fever.

•Difficulty falling asleep.

Common(may affect up to 1 in 10 people)

•Blood clots in blood vessels.

•Reduced blood flow to the heart muscle due to obstruction or constriction of coronary arteries.

•Chest pain.

•Decreased amount of blood pumped by the heart.

•Fluid retention including around the lungs.

•Infections.

•Complication of a severe infection (the infection is present in the bloodstream) that can cause tissue damage, organ failure, and death.

•Low blood sugar (see section 2).

•Protein loss in urine that can cause swelling.

•Pseudogripal syndrome.

•Alteration of blood tests including pancreatic and liver enzymes.

•High levels of uric acid in the blood.

•Hemorrhoids, rectal pain, gingival bleeding, difficulty swallowing or inability to swallow.

•Burning sensation or pain in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.

•Weight loss.

•Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.

•Runny nose, nasal congestion.

•Excessive tear production.

•Abnormal skin sensation, itching, scaly and inflamed skin, blisters, acne, change in nail color, hair loss.

•Abnormal sensation in the extremities.

•Abnormally decreased or increased sensitivity, especially to touch.

•Heartburn.

•Dehydration.

•Hot flashes.

•Abnormal urine color.

•Depression.

•Chills.

Uncommon(may affect up to 1 in 100 people)

•Potentially fatal soft tissue infection, including the anogenital region (see section 2).

•Cerebrovascular accident.

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

•Abnormal heart rhythm or arrhythmia.

•Fluid around the heart (pericardial effusion).

•Liver failure.

•Abdominal pain caused by pancreatitis.

•Tumor destruction causing a perforation in the intestine (perforation).

•Bile duct inflammation, associated or not with gallstones.

•Abnormal tube formation like a conduit from a normal body cavity to another body cavity or to the skin.

•Mouth, tooth, and/or maxillary pain, swelling, or sores inside the mouth, numbness or a feeling of heaviness in the maxilla, or the feeling that a tooth is loose. All of these may be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.

•Overproduction of thyroid hormones that increase the amount of energy the body consumes at rest.

•Problems with wound healing after surgery.

•High levels of a muscle enzyme (creatine phosphokinase) in the blood.

•Excessive reaction to an allergen, including pollen allergy, skin rash, itching, urticaria, swelling of body parts, and difficulty breathing.

•Colitis, ischemic colitis.

Rare(may affect up to 1 in 1,000 people)

•Severe skin and/or mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).

•Tumor lysis syndrome (TLS) – TLS includes a series of metabolic complications that can occur during cancer treatment. These complications are caused by the products released by dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, dark urine, and fatigue, associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood) that can lead to kidney function changes and acute kidney failure.

•Abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis).

•Abnormal changes in the brain that can cause a series of symptoms including headache, confusion, seizures, and vision loss (posterior reversible encephalopathy syndrome).

•Painful skin ulceration (pyoderma gangrenosum).

•Liver inflammation (hepatitis).

•Thyroid gland inflammation.

•Vascular damage to the smallest blood vessels known as microangiopathic thrombosis (MAT).

Unknown(the frequency cannot be estimated from available data):

•Increased and weakened arterial wall or tearing of the arterial wall (aneurysms and arterial dissections).

• lack of energy, confusion, drowsiness, unconsciousness/coma - these symptoms may be signs of cerebral toxicity caused by high levels of ammonia in the blood (hyperammonemic encephalopathy)

Reporting of side effects

If you experience any type of side effect, consult your doctor, hospital pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, bottle, and blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been opened.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sunitinib Dr. Reddys

Sunitinib Dr. Reddys 12.5 mg hard capsules EFG

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib. The other components are:

• Capule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, Sunitinib Dr. Reddys contains sodium), magnesium stearate.
• Capule coating:gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).
• Printing ink:shellac, titanium dioxide (E171), propylene glycol.

Sunitinib Dr. Reddys 25 mg hard capsules EFG

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib. The other components are:

• Capule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, Sunitinib Dr. Reddys contains sodium), magnesium stearate.
• Capule coating:gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).
• Printing ink:shellac, titanium dioxide (E171), propylene glycol.

Sunitinib Dr. Reddys 50 mg hard capsules EFG

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib. The other components are:

• Capule content:povidone, microcrystalline cellulose, sodium croscarmellose (see section 2, Sunitinib Dr. Reddys contains sodium), magnesium stearate.
• Capule coating:gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).
• Printing ink:shellac, iron oxide black (E172), propylene glycol.

Appearance of the product and contents of the pack

Sunitinib Dr. Reddys 12.5 mg hard capsules EFG

Sunitinib Dr. Reddys 12.5 mg: hard gelatin capsule (capsule) with an orange-coloured cap and an orange-coloured body, with "SNB" and "12.5" printed in white ink on the body. The capsule contains orange-coloured powder. Capsule size: 4 (length of approximately 14 mm).

Sunitinib Dr. Reddys 25 mg hard capsules EFG

Sunitinib Dr. Reddys 25 mg: hard gelatin capsule (capsule) with a caramel-coloured (light brown) cap and an orange-coloured body, with "SNB" and "25" printed in white ink on the body. The capsule contains orange-coloured powder. Capsule size: 3 (length of approximately 16 mm).

Sunitinib Dr. Reddys 50 mg hard capsules EFG

Sunitinib Dr. Reddys 50 mg: hard gelatin capsule (capsule) with a caramel-coloured cap and a caramel-coloured (light brown) body, with "SNB" and "50" printed in black ink on the body. The capsule contains orange-coloured powder. Capsule size: 1EL (length of approximately 20 mm).

It is available in plastic containers with desiccant of 30, 60 (2 x 30) or 90 (3 x 30) capsules, in pre-cut blister packs with desiccant containing 28, 30, 60 (2 x 30) or 90 (3 x 30) capsules and, in single-dose pre-cut blister packs with desiccant containing 28 x 1, 30 x 1, 60 (2 x 30 x 1) or 90 (3 x 30 x 1) capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona (Spain)

Telephone: 93 355 49 16

Fax: 93 355 49 61

Responsible for manufacturing

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Synthon s.r.o.

Brnenská 32 /cp. 597

678 01 Blansko

Czech Republic

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Last update of thisleaflet:May 2024

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)