Sunitinib Dr. Reddy's 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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 the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet Contents

1. What Sunitinib Dr. Reddys is and what it is used for
2. What you need to know before taking Sunitinib Dr. Reddys
3. How to take Sunitinib Dr. Reddys
4. Possible side effects
5. How to store Sunitinib Dr. Reddys
6. 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 blocking 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 tumour (GIST), a type of cancer of the stomach and intestine, when imatinib (another anti-tumour medicine) has failed or cannot be used.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumours (pNET) (tumours of hormone-secreting cells in the pancreas) that have progressed or cannot be surgically removed.

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

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

Do not take Sunitinib Dr. Reddys:

• 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 starting treatment with 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 lower blood pressure.

• If you have or have had blood disorders, bleeding problems or bruising. Treatment with sunitinib may lead to a higher risk of bleeding or cause changes in the number of certain blood cells, which may result in anemia or affect blood's ability to clot. If you are taking warfarin or acenocoumarol, medicines that thin the blood to prevent clots, there may be an increased 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, become short of breath, or have swollen feet or ankles.

• If you have abnormal heart rhythms. Sunitinib may cause irregularities in heart rhythm. Your doctor may perform electrocardiograms (ECGs) to assess these issues during treatment with sunitinib. Consult your doctor if, during treatment with this medicine, you feel dizzy, weak, or experience abnormal heartbeats.

• If you have recently had blood clots in veins and/or arteries (types of blood vessels), including stroke, myocardial infarction, 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, difficulty speaking, headache, or dizziness while being treated with sunitinib.

• If you have or have had an aneurysm (a bulge 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, or seizures.

• If you have thyroid gland problems. Sunitinib may cause thyroid gland problems. Contact your doctor if you feel more tired than usual, feel cold more often than others, or your voice becomes deeper while taking sunitinib. Thyroid function should be checked before starting treatment with this medicine and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with replacement thyroid hormone.

• 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, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to monitor liver function before and during treatment with this medicine, as well as whenever 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 scheduled for surgery, you will usually stop taking sunitinib. Your doctor will decide when to restart this medicine.

• Before starting treatment with sunitinib, you may be advised to have a dental check-up.

• If you have or have had mouth, teeth, and/or jaw pain, swelling or sores inside the mouth, numbness, or a feeling of heaviness in the jaw, or if your teeth feel loose, inform your doctor and dentist immediately.

• If you need to undergo invasive dental treatment or dental surgery, inform your dentist that you are being treated with sunitinib, particularly if you are also receiving or have received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may occur due to other medical conditions.

• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be fatal) may occur. Contact your doctor immediately if you notice signs of infection around a skin lesion, such as fever, pain, redness, swelling, or pus or blood discharge. This reaction is generally reversible after stopping sunitinib. Serious skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use, initially appearing as red, target-like spots or circular lesions, often with central blisters on the trunk. This rash may progress to widespread blistering or skin peeling and can be life-threatening. Contact your doctor immediately if you develop a skin rash or the skin symptoms described.

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

• If you have diabetes. Blood glucose levels in diabetic patients should be checked regularly to determine whether the dose of antidiabetic medication 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, or loss of consciousness).

Children and adolescents

The use of Sunitinib Dr. Reddys is not recommended in individuals under 18 years of age.

Other medicines and Sunitinib Dr. Reddys

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

Some medicines may affect sunitinib levels in your body. You must inform your doctor if you are taking medicines containing 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 conditions (such as allergic/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions
• herbal remedies containing St. John’s wort (Hypericum perforatum) – used to treat depression and anxiety

Taking Sunitinib Dr. Reddys with food and drinks

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

Pregnancy and breastfeeding

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

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

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

Driving and using machines

If you experience dizziness or unusual tiredness, exercise particular caution 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., essentially "sodium-free."

3. How to take Sunitinib Dr. Reddys

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

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

• GIST or RCC: the usual dose is 50 mg once daily for 28 days (4 weeks), followed by 14 days (2 weeks) off treatment (no medication) in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily without a treatment break.

Your doctor will advise you on the appropriate dose you need to take, as well as whether you need to interrupt sunitinib treatment 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 along the perforated lines. Then peel back the foil and remove the capsule. Do not push the capsule through the foil as this may damage the capsule.

If you take more Sunitinib Dr. Reddys than you should

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

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

If you forget to take Sunitinib Dr. Reddys

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

4. Possible adverse effects

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

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

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

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

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

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

• Tumor destruction leading to intestinal perforation. 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 due to fluid accumulation under the skin and around the eye, severe allergic skin rash.
• Mouth pain/irritation, mouth ulcers/inflammation/dryness in the mouth, taste disturbances, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration, 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 sleeping.

Common (may affect up to 1 in 10 people)

• Blood clots in blood vessels.
• Reduced blood flow to the heart muscle due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complication of a severe infection (infection present in the bloodstream) that may cause tissue damage, organ failure, and death.
• Low blood sugar level (see section 2).
• Loss of protein in urine, which may cause swelling.
• Pseudoflu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High blood uric acid level.
• Hemorrhoids, rectal pain, bleeding gums, difficulty swallowing or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tearing.
• Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, change in nail color, hair loss.
• Abnormal sensation in the limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Indigestion.
• Dehydration.
• Hot flushes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon (may affect up to 1 in 100 people)

• Potentially life-threatening soft tissue infection, including in the anogenital region (see section 2).
• Stroke.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.
• Changes in the heart's electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumor destruction causing a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal passage or channel from one body cavity to another or to the skin.
• Pain in the mouth, teeth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loose teeth. These may be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones increasing the body's resting energy expenditure.
• Problems with wound healing after surgery.
• Elevated blood levels of a muscle enzyme (creatine phosphokinase).
• Severe allergic reaction, including pollen allergy, skin rash, skin 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 includes a series of metabolic complications that may occur during cancer treatment. These complications are caused by substances released from dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, dark urine, and fatigue, associated with abnormal laboratory results (high levels of potassium, uric acid, and phosphate, and low calcium levels in blood), which may lead to changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscle tissue that may lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that may cause a range of symptoms including 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 the smallest blood vessels known as thrombotic microangiopathy (TMA).

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

• Aneurysm (bulging and weakening of the blood vessel wall) or dissection of the blood vessel wall (arterial aneurysms and dissections).
  • lack of energy, confusion, drowsiness, unconsciousness/coma – these symptoms may be signs of brain toxicity caused by high levels of ammonia in the blood (hyperammonaemic encephalopathy)

Reporting of adverse effects

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

5. Sunitinib Dr. Reddys Storage Instructions

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

Do not use this medicine after the expiry date stated on the pack, bottle, and blister after EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

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:

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

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

• Capsule contents: 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.

Nature and contents of the container

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, printed with “SNB” and “12.5” in white ink on the body. The capsule contains orange 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-coloured (light brown) cap and an orange body, printed with “SNB” and “25” in white ink on the body. The capsule contains orange 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-coloured cap and a caramel-coloured body (light brown), printed with “SNB” and “50” in black ink on the body. The capsule contains orange powder. Capsule size: 1EL (elongated: approximately 20 mm in length).

Available in plastic containers with desiccant containing 30, 60 (2 x 30) or 90 (3 x 30) capsules, in pre-formed blisters with desiccant containing 28, 30, 60 (2 x 30) or 90 (3 x 30) capsules, and in single-dose pre-formed 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 certain 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

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

The 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 under the following names:

Date of the most recent review of this package leaflet: 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/)