Sunitinib Tecnigen 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sunitinib TecniGen 25 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. 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 must not be given to other people, even if they have the same symptoms as you. 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 for the treatment of 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 tumor (GIST), a type of cancer of the stomach and intestine, when imatinib (another anticancer medicine) has already failed or when imatinib cannot be used.
• 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 by surgery.

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 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 treatment with Sunitinib TecniGen

• If you have high blood pressure. Sunitinib may 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 may cause heart-related issues. Consult your doctor if you feel very tired, short of breath, or have swollen feet or ankles.

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

• 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 bulge 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, exhaustion, bruising, bleeding, swelling, confusion, vision loss, or seizures.

• If you have thyroid gland problems. Sunitinib may 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 replacement thyroid hormone.

• 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 sunitinib treatment: 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 sunitinib treatment, 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 undergoing surgery, you will generally stop taking sunitinib. Your doctor will decide when to restart sunitinib treatment.

• Before starting sunitinib treatment, 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 in the mouth, numbness or heaviness 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, you may develop "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be fatal). 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 experience 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 assess whether the dose of antidiabetic medication needs adjustment, minimizing 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

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 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 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 or hypericum (Hypericum perforatum) – used to treat depression and anxiety

Taking Sunitinib TecniGen 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 could 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 while being treated with sunitinib.

Driving and using machines

Exercise caution when driving or operating machinery if you experience dizziness or unusual tiredness.

Sunitinib TecniGen contains Mannitol

May have a mild laxative effect due to the presence of mannitol.

Sunitinib TecniGen contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., 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 (no 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 starting to take Sunitinib TecniGen):

Heart problems. Consult your doctor if you feel very tired, are short of breath, or have swollen feet and 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 have any of these symptoms or experience 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 bloody sputum from the lungs or airways.

Tumour destruction leading to perforation of 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

• Decrease 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 color changes, excessive skin pigmentation, hair color changes, skin 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.
• 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 serious 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.
• Pseudo-flu syndrome.
• Abnormal blood test results, including enzymes of the pancreas and liver.
• High level of uric acid in blood.
• Haemorrhoids, 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 (pain in muscles and bones), muscle weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry nose, nasal congestion.
• Excessive tearing.
• Abnormal skin sensation, itching, scaly and inflamed skin, blisters, acne, nail color changes, 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 (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 connection 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 bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones, increasing the amount of energy the body uses at rest.
• Problems with wound healing 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 difficulty breathing.
• Inflammation of the colon (colitis, ischaemic 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).
• Tumour 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, 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 that may cause a range of symptoms including headache, confusion, seizures, and loss of vision (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 after EXP. The expiry date is 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 having been opened.

Medicines must not be disposed of via wastewater or in household waste. Unused containers and 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. Contents of the pack and other information

Composition of Sunitinib TecniGen

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

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

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

Appearance of the product and contents of the pack:

Sunitinib TecniGen 25 mg hard capsules are gelatin capsules with an opaque red body and an opaque orange cap.

Sunitinib TecniGen 25 mg hard capsules are available in blister packs containing 28 and 30 capsules.

Only some 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 25 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/