SUNINITIB DR. REDDYS 12.5 mg HARD CAPSULES

Introduction

Package Leaflet: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 all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sunitinib Dr. Reddys is and what it is used for
2. What you need to know before you take Sunitinib Dr. Reddys
3. How to take Sunitinib Dr. Reddys
4. Possible side effects

5 Storage of Sunitinib Dr. Reddys

1. Contents of the pack and other information

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

Sunitinib Dr. Reddys contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer and works by preventing the activity of a special 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 intestine cancer, when imatinib (another anti-cancer medicine) has failed or when imatinib 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 the hormone-producing cells in the pancreas) that have progressed or cannot be removed by surgery.

If you have any questions about how Sunitinib Dr. Reddys works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Sunitinib Dr. Reddys

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

Talk to your doctor before taking Sunitinib Dr. Reddys:

• If you have high blood pressure. Sunitinib may increase blood pressure. Your doctor may check your blood pressure during treatment with this medicine and treat you with blood pressure-lowering medicines if necessary.

• If you have or have had blood disorders, bleeding problems, or bruising. Treatment with sunitinib may lead to a high 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, medicines that thin the blood to prevent clots, there may be a higher risk of bleeding. If you experience any bleeding during treatment with this medicine, talk to your doctor.

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

• If you have abnormal heart rhythms. Sunitinib may cause abnormal heart rhythms. Your doctor may perform electrocardiograms to evaluate these problems during treatment with sunitinib. Talk to your doctor if you feel dizzy, weak, or have abnormal heartbeats during treatment with this medicine.

• If you have recently had 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, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, speech problems, headache, or dizziness while taking sunitinib.

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

• If you have or have had damage to the small blood vessels known as thrombotic microangiopathy (TMA). Contact your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.

• If you have thyroid problems. Sunitinib may cause thyroid problems. Contact your doctor if you feel more tired than usual, feel colder than others, or your voice becomes hoarse while taking sunitinib. Before treatment with this medicine, your thyroid function should be checked, and periodically while you are 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 or gallbladder disorders. Contact your doctor if you develop 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. 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 stomach 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 kidney function.

• If you are going to have surgery or have recently had an operation. Sunitinib Dr. Reddys may affect wound healing. If you are going to have an operation, 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 check-up

• If you have or have had pain in the mouth, teeth, and/or jaw, swelling, or ulcers inside the mouth, numbness, or a feeling of heaviness in the jaw, or a feeling that a tooth is loose, tell your doctor and dentist immediately.

• If you need to have invasive dental treatment or dental surgery, tell your dentist that you are taking sunitinib, especially if you are also being treated with intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may occur due to another medical condition.

• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (rapidly spreading skin/soft tissue infection that can be life-threatening) may occur. 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 with sunitinib, which initially had the appearance of target-like spots or circular patches, often accompanied by central blisters on the trunk. This rash may progress to widespread blisters or peel, and can be life-threatening. Contact your doctor immediately if you develop a skin rash or the skin symptoms mentioned.

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

• If you have diabetes. Blood glucose levels should be regularly checked in diabetic patients to assess whether the dose of the anti-diabetic medicine needs to be adjusted to minimize the risk of low blood sugar. 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 children and adolescents under 18 years of age.

Other medicines and Sunitinib Dr. Reddys

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

• 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 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 (Hypericum perforatum) - used to treat depression and anxiety

Taking Sunitinib Dr. Reddys with food and drinks

You should avoid taking grapefruit juice while taking sunitinib.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you are breast-feeding, inform your doctor. You should not breast-feed while taking sunitinib.

Driving and using machines

If you experience dizziness or unusual tiredness, be careful when driving or using machinery.

Sunitinib Dr. Reddys contains sodium

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

3. How to take Sunitinib Dr. Reddys

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask your doctor again.

Your doctor will determine the correct dose depending on the type of cancer being treated. If you are going to receive treatment for:

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

Your doctor will tell you the dose you need to take and whether you need to stop treatment with sunitinib and when.

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

How to open the peelable blister

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

If you take more Sunitinib Dr. Reddys than you should

If you have accidentally taken too many capsules, talk to your doctor immediately. You may need medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sunitinib Dr. Reddys

Do not take a double dose to make up for forgotten doses.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should contact your doctor immediately if you experience any of these serious adverse effects (see also What you need to know before taking Sunitinib Dr. Reddys):

• Heart problems. Consult your doctor if you feel very tired, are short of breath, or have swollen feet and ankles. They 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 breathing problems, or cough up blood. They may be symptoms of a situation called pulmonary embolism that occurs when blood clots travel to the lungs.

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

• Bleeding. Consult your doctor if you have any of these symptoms or a serious bleeding problem during treatment with sunitinib: painful or swollen stomach (abdomen); vomiting blood; having black, tarry stools; urinating with blood; having a headache or some change in your mental state; coughing up blood or bloody sputum from the lungs or airways.

• 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 adverse 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.
• Rapid swelling of tissues caused by fluids under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth ulcers/inflammation/dryness, taste disorders, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/decreased appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair color change, skin rash on the palms of the hands and soles of the feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

Common(may affect up to 1 in 10 people)

• Blood clots in blood vessels.
• Lack of blood flow to the heart muscle due to obstruction or constriction of the coronary arteries.
• Chest pain.
• Decrease in the amount of blood pumped by the heart.
• Fluid retention including around the lungs.
• Infections.
• Complication of a severe infection (infection is present in the bloodstream) that can cause tissue damage, organ failure, and death.
• Decreased blood sugar level (see section 2).
• Loss of protein in the urine that can cause swelling.
• Pseudogrippal syndrome.
• Alteration of blood tests including pancreatic and liver enzymes.
• High level of uric acid in the blood.
• Hemorrhoids, rectal pain, gum bleeding, difficulty swallowing or inability to swallow.
• Sensation of burning or pain in the tongue, inflammation of the digestive tract lining, excess gas in the stomach or intestine.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.
• Nasal dryness, nasal congestion.
• Excessive tear production.
• Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, nail color change, hair loss.
• Abnormal sensation in the limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon(may affect up to 1 in 100 people)

• Potentially life-threatening soft tissue infection, including the anal-genital region (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or decrease of blood flow to the heart.
• Changes in the electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach pain (abdomen) caused by pancreas inflammation.
• Tumor destruction causing a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal tube-like structure from a normal body cavity to another body cavity or to the skin.
• Pain in the mouth, teeth, and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or feeling that a tooth is moving. All of these can be signs and symptoms of jawbone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones that increase the amount of energy the body uses at rest.
• Problems with wound healing after surgery.
• High level in the blood of an enzyme (creatine phosphokinase) of the muscle.
• Excessive reaction to an allergen, including pollen allergy, skin rash, itching, hives, swelling of body parts, 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 reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS) - TLS encompasses a series of metabolic complications that can occur during cancer treatment. These complications are caused by products released by dying cancer cells and can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, darkening of 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 changes in kidney function and acute kidney failure.
• Abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a range of symptoms including headache, confusion, seizures, and loss of vision (posterior reversible leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damaged small blood vessels known as thrombotic microangiopathy (TMA).

Unknown(frequency cannot be estimated from available data):

• Increased and weakened blood vessel wall or tear of the blood vessel wall (aneurysms and arterial dissections).
  • Lack of energy, confusion, drowsiness, unconsciousness/coma - these symptoms can be signs of cerebral toxicity caused by high levels of ammonia in the blood (hyperammonemic encephalopathy)

Reporting Adverse Effects

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

5. Storage of Sunitinib Dr. Reddys

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging, bottle, and blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sunitinib Dr. Reddys

Sunitinib Dr. Reddys 12.5 mg hard capsules EFG

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

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

Sunitinib Dr. Reddys 25 mg hard capsules EFG

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

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

Sunitinib Dr. Reddys 50 mg hard capsules EFG

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

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

Appearance of the Product and Package Contents

Sunitinib Dr. Reddys 12.5 mg hard capsules EFG

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

Sunitinib Dr. Reddys 25 mg hard capsules EFG

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

Sunitinib Dr. Reddys 50 mg hard capsules EFG

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

It is available in plastic containers with desiccant containing 30, 60 (2 x 30), or 90 (3 x 30) capsules, in precut blisters with desiccant containing 28, 30, 60 (2 x 30), or 90 (3 x 30) capsules, and in single-dose precut blisters 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 package sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona (Spain)

Phone: 93 355 49 16

Fax: 93 355 49 61

Manufacturer

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus:May 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)