Sunitinib Tecnigen 12.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sunitinib TecniGen 12.5 mg hard capsules EFG

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

Contents of the leaflet

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

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

This medicine 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 spread of cancer cells.

Sunitinib TecniGen 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 anticancer medicine) has already 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 the hormone-secreting cells in the pancreas) that have progressed or cannot be surgically removed.

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

2. What you need to know before starting to take Sunitinib TecniGen

Do not take Sunitinib TecniGen

• 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 to take Sunitinib TecniGen

• If you have high blood pressure. Sunitinib can increase blood pressure. Your doctor may monitor your blood pressure during treatment with sunitinib, and if necessary, you may be treated with medications that lower 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 cause changes in the number of certain blood cells, which may result in anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol—medications that thin the blood to prevent clots—there may be an increased risk of bleeding. If you experience any bleeding during treatment with sunitinib, consult your doctor.

• If you have heart problems. Sunitinib can cause heart-related issues. Consult your doctor if you feel very tired, become short of breath, or have swollen feet or ankles.

• If you have abnormal changes in heart rhythm. Sunitinib can cause irregularities in heart rhythm. Your doctor may perform electrocardiograms (ECGs) to assess these issues during treatment with sunitinib. Contact your doctor if you feel dizzy, faint, or experience irregular heartbeats during treatment.

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

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

• If you have suffered or are suffering from damage to the smallest blood vessels, known as thrombotic microangiopathy (TMA). Contact your doctor if you experience fever, fatigue, bruising, bleeding, swelling, confusion, vision loss, or seizures.

• If you have thyroid gland problems. Sunitinib can cause thyroid-related issues. Contact your doctor if you feel unusually tired, feel colder than usual, or your voice becomes deeper while taking sunitinib. Thyroid function should be monitored before starting sunitinib and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement therapy.

• 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 abdomen), nausea, vomiting, or 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 sunitinib, as well as whenever clinically indicated.

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

• If you are scheduled for surgery or have recently undergone surgery. Sunitinib may affect wound healing. If you are due to have surgery, you will generally need to stop taking sunitinib. Your doctor will decide when to restart treatment.

• 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 heavy sensation in the jaw, or loose teeth, inform your doctor and dentist immediately.

• If you require invasive dental treatment or dental surgery, inform your dentist that you are being treated with sunitinib, especially if you are also receiving or have previously received intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone complications that may have been administered for 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" (a rapidly spreading skin/soft tissue infection that can be life-threatening) 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. These rashes initially appear as red, target-like spots or circular lesions, often with central blisters, typically on the trunk. The 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 described skin symptoms.

• 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 adjustment, minimizing 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, or loss of consciousness).

Children and adolescents

Sunitinib is not recommended for use in individuals under 18 years of age.

Other medicines and Sunitinib TecniGen

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 can 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 HIV
• 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 TecniGen with food and drink

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 must 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, take special care when driving or operating machinery.

Sunitinib TecniGen contains Mannitol

May have a mild laxative effect due to mannitol.

Sunitinib TecniGen contains Sodium

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

3. How to take Sunitinib TecniGen

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

Your doctor will determine the correct dose for you 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 daily for 28 days (4 weeks), followed by a 14-day (2-week) rest period (without medication) in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily without a rest period.

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

Sunitinib may be taken with or without food.

If you take more Sunitinib TecniGen 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 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Sunitinib TecniGen

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 you start taking Sunitinib TecniGen):

Heart problems. Consult your doctor if you feel very tired, become 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 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 the 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 and tarry stools, blood in urine, headache, changes in mental status, coughing up blood or blood-stained sputum from the lungs or airways.

Tumour 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 tiredness, loss of strength.
• Swelling of tissues due to fluid accumulation under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach discomfort, nausea, vomiting, diarrhoea, 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 colour changes, excessive skin pigmentation, hair colour changes, 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 blockage or narrowing of the coronary arteries.
• Chest pain.
• Reduced 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 levels (see section 2).
• Protein loss in urine which may cause swelling.
• Pseudoinfluenza syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in blood.
• Haemorrhoids, 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), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tear production.
• Abnormal skin sensations, itching, scaly and inflamed skin, blisters, acne, nail colour changes, hair loss.
• Abnormal sensations in the limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Indigestion (heartburn).
• Dehydration.
• Hot flushes.
• Abnormal urine colour.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially life-threatening soft tissue infection, including the anogenital region (see section 2).
• Stroke.
• Myocardial infarction (heart attack) caused by interruption or reduction of blood flow to the heart.
• Changes in the electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain caused by inflammation of the pancreas.
• Tumour destruction leading to a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal tube-like passage from one body cavity to another body cavity 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 jaw bone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones increasing the body's resting energy expenditure.
• Wound healing problems after surgery.
• Elevated blood levels of a muscle enzyme (creatine phosphokinase).
• Excessive reaction to an allergen, including pollen allergy, skin rash, skin itching, hives, swelling of body parts, and breathing difficulties.
• Inflammation of the colon (colitis, ischaemic 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).
• Tumour lysis syndrome (TLS) – TLS encompasses 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, 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 changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscles which may lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain which 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).

Frequency not known (cannot be estimated from available data)

• Enlargement and weakening of a blood vessel wall or tearing of a blood vessel wall (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 (hyperammonaemic encephalopathy).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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. Storage of Sunitinib TecniGen

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the month indicated.
• 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 prior opening.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and unwanted medicines should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Sunitinib TecniGen

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

Capsule contents: mannitol (E-421), sodium croscarmellose, povidone (K-25), magnesium stearate

Capsule shell: gelatin, iron oxide red (E-172), titanium dioxide (E-171)

Appearance of the product and contents of the container:

Sunitinib TecniGen 12.5 mg hard capsules are red, opaque gelatin capsules with a red, opaque cap.

Sunitinib TecniGen 12.5 mg hard capsules are available in blister packs containing 28 and 30 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid)
Spain

Manufacturer

Tecnimede – Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

Local representative:
Pharmavic Ibérica, S.L.
Compositor Lehmberg Ruiz, 6. Office 7
29007 Málaga. Spain.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal – Sunitnib TecniGen
Spain – Sunitinib TecniGen 12.5 mg hard capsules EFG

Date of the most recent revision of this leaflet: October 2024

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