Axitinib Teva 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Axitinib Teva 1 mg film-coated tablets EFG

Axitinib Teva 5 mg film-coated tablets 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, because it may 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 Axitinib Teva is and what it is used for
2. What you need to know before taking Axitinib Teva
3. How to take Axitinib Teva
4. Possible side effects
5. How to store Axitinib Teva
6. Contents of the pack and other information

1. What Axitinib Teva is and what it is used for

This medicine contains the active substance axitinib. Axitinib reduces the blood supply to the tumour and slows cancer growth.

Axitinib is indicated for the treatment of advanced renal cell carcinoma (advanced kidney cancer) in adults when other medicines (called sunitinib or cytokines) are unable to stop the progression of the disease.

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

2. What you need to know before starting to take Axitinib Teva

Do not take Axitinib Teva:

If you are allergic to axitinib or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, consult your doctor.

Warnings and precautions

Talk to your doctor or nurse before taking Axitinib Teva:

• If you have high blood pressure.

Axitinib can increase blood pressure. It is important to monitor your blood pressure before starting this medicine and periodically during treatment. If you have high blood pressure (hypertension), you may be treated with medications that lower blood pressure. Your doctor must ensure that your blood pressure is controlled before starting treatment with axitinib and throughout treatment with this medicine.

• If you have thyroid gland problems.

Axitinib may cause thyroid gland problems. Contact your doctor if you feel unusually tired, are often colder than other people, or your voice becomes deeper while taking this medicine. Thyroid function should be checked before starting axitinib treatment and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement therapy before or during treatment with this medicine.

• If you have recently had blood clotting problems in veins or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Call emergency services immediately and contact your doctor 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, vision changes, or dizziness while on this medicine.

• If you have or have had bleeding disorders.

Axitinib may increase the risk of bleeding. Inform your doctor if you experience bleeding, cough up blood, or produce bloody sputum while taking this medicine.

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

• If during treatment with this medicine you experience severe or persistent stomach (abdominal) pain.

Axitinib may increase the risk of developing a stomach or intestinal ulcer or the formation of fistulas (an abnormal passage or connection from one internal organ or body cavity to another or to the skin). Contact your doctor if you experience severe abdominal pain while taking this medicine.

• If you are scheduled for surgery or have an unhealed wound.

Your doctor should discontinue axitinib at least 24 hours before surgery, as it may impair wound healing. Treatment with this medicine should be resumed only once the wound has healed properly.

• If during treatment with this medicine you experience symptoms such as headache, confusion, seizures (epileptic fits), or vision changes, with or without high blood pressure.

Call emergency services immediately and contact your doctor. This may be a rare neurological side effect known as reversible posterior leukoencephalopathy syndrome.

• If you have liver problems.

Your doctor should perform blood tests to monitor liver function before and during treatment with axitinib.

• If during treatment with this medicine you experience symptoms such as excessive tiredness, abdominal swelling, leg or ankle swelling, difficulty breathing, or prominent neck veins (distended veins).

Axitinib may increase the risk of heart failure events. Your doctor should monitor regularly for signs or symptoms of heart failure throughout treatment with axitinib.

Use in children and adolescents

Axitinib is not recommended for patients under 18 years of age. This medicine has not been studied in children or adolescents.

Other medicines and Axitinib Teva

Some medicines may affect axitinib or be affected by it. Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines, vitamins, and herbal supplements. The medicines listed in this leaflet may not be the only ones that interact with axitinib.

The following medicines may increase the risk of side effects with axitinib:

• ketoconazole or itraconazole, used to treat fungal infections;
• clarithromycin, erythromycin, or telithromycin, antibiotics used to treat bacterial infections;
• atazanavir, indinavir, nelfinavir, ritonavir, or saquinavir, used to treat HIV/AIDS infections;
• nefazodone, used to treat depression.

You must not take these medicines during treatment with axitinib. If you are taking any of them, inform your doctor, pharmacist, or nurse. Your doctor may adjust the dose of these medicines, adjust the dose of axitinib, or switch to another medicine.

Axitinib may increase the adverse effects associated with theophylline, used to treat asthma or other lung diseases.

Taking Axitinib Teva with food and drink

Do not take this medicine with grapefruit or grapefruit juice, as it may increase the risk of adverse effects.

Pregnancy and breastfeeding

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

• Axitinib may harm the unborn baby or breastfed infant.

• Do not take this medicine during pregnancy. If you are pregnant or think you may be pregnant, consult your doctor before taking it.

• During treatment with axitinib and for at least 1 week after the last dose, use a reliable method of contraception to prevent pregnancy.

• Do not breastfeed during treatment with axitinib. If you are breastfeeding, your doctor will advise you whether to stop breastfeeding or stop treatment with axitinib.

Driving and using machines

If you experience dizziness and/or feel tired while taking axitinib, exercise special caution when driving or operating machinery.

Axitinib Teva contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Axitinib Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; essentially “sodium-free”.

3. How to take Axitinib Teva

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is 5 mg twice daily. Your doctor may subsequently increase or decrease your dose depending on how well you tolerate treatment with axitinib.

Swallow the tablets whole with some water, with or without food. Take doses of axitinib approximately every 12 hours.

Use in children and adolescents

Axitinib is not recommended for individuals under 18 years of age. This medicine has not been studied in children and adolescents.

If you take more Axitinib Teva than you should

If you accidentally take more tablets or a higher dose than required, contact your doctor immediately for advice. If possible, show your doctor the packaging or this leaflet. 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 medication and the amount ingested.

If you forget to take Axitinib Teva

Take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you vomit while taking Axitinib Teva

If you vomit, do not take an additional dose. Take the next prescribed dose at your usual time.

If you stop taking Axitinib Teva

If you are unable to take this medicine as prescribed by your doctor, or think you no longer need it, contact your doctor immediately.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Some adverse effects can be serious. You must contact your doctor immediately if you experience any of the following serious adverse effects (see also section 2 “What you need to know before starting to take Axitinib Teva”):

• Heart failure events. Contact your doctor if you experience excessive tiredness, swelling of the abdomen, legs or ankles, difficulty breathing, or bulging neck veins.

• Blood clots in veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Call emergency services immediately and contact your doctor 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, vision changes, or dizziness.

• Bleeding. Inform your doctor if you experience any of these symptoms or have a serious bleeding problem while being treated with axitinib: black or tarry stools, coughing up blood or bloody sputum, or changes in mental status.

• Stomach or intestinal ulcer or fistula formation (an abnormal tube-like passage from one normal body cavity to another body cavity or to the skin). Contact your doctor if you have severe abdominal pain.

• Severe increase in blood pressure (hypertensive crisis). Contact your doctor if you have very high blood pressure, severe headache, or severe chest pain.

• Reversible brain disorder (posterior reversible encephalopathy syndrome). Call emergency services immediately and contact your doctor if you experience symptoms such as headache, confusion, seizures (epileptic attacks), or vision changes, with or without high blood pressure.

Other adverse effects with axitinib may include:

Very common: may affect more than 1 in 10 people

• High blood pressure or increases in blood pressure.
• Diarrhea, nausea or vomiting, stomach pain, indigestion, mouth irritation, tongue or throat irritation, constipation.
• Shortness of breath, cough, hoarseness.
• Lack of energy, feeling weak or tired.
• Low thyroid gland activity (can be seen in blood tests).
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome), skin rash, dry skin.
• Joint pain, pain in hands or feet.
• Loss of appetite.
• Protein in urine (can be seen in urine tests).
• Weight loss.
• Headache, taste disturbance, or loss of taste.

Common: may affect up to 1 in 10 people

• Dehydration (loss of body fluids).
• Kidney failure.
• Flatulence (gas), hemorrhoids, bleeding gums, rectal bleeding, burning or stinging sensation in the mouth.
• Hyperthyroidism (can be seen in blood tests).
• Sore throat or irritation of nose and throat.
• Muscle pain.
• Nosebleeds.
• Itching of the skin, skin redness, hair loss.
• Ringing or other sounds in the ears (tinnitus).
• Decreased red blood cell count (can be seen in blood tests).
• Decreased platelet count (blood cells that help blood to clot) (can be seen in blood tests).
• Presence of red blood cells in urine (can be seen in urine tests).
• Changes in levels of different substances/enzymes in the blood (can be seen in blood tests).
• Increased red blood cell count (can be seen in blood tests).
• Swelling of the abdomen, legs or ankles, bulging neck veins, excessive tiredness, difficulty breathing (signs of heart failure events).
• Fistula (abnormal passage originating from a normal body cavity to another body cavity or to the skin).
• Dizziness.
• Inflammation of the gallbladder.

Uncommon: may affect up to 1 in 100 people

• Reduced white blood cell count (can be seen in blood tests).

Frequency not known: cannot be estimated from available data

• Increase and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (arterial aneurysms and dissections).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Axitinib Teva

Keep 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 refers to the last day of the month indicated.

Store in the original container to protect from moisture. This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Axitinib Teva

• The active substance is axitinib.

Axitinib Teva 1 mg: each tablet contains 1 mg of axitinib.

Axitinib Teva 5 mg: each tablet contains 5 mg of axitinib.

• The other components are microcrystalline cellulose, lactose monohydrate (see section 2, Axitinib Teva contains lactose), sodium croscarmellose (see section 2, Axitinib Teva contains sodium), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin (E1518), and red iron oxide (E172).

Appearance of the product and contents of the pack

Axitinib Teva 1 mg film-coated tablets are red, round biconvex tablets, approximately 6 mm in diameter, with "A7TI" engraved on one side and "1" on the other.

Axitinib Teva 5 mg film-coated tablets are red, oval biconvex tablets, approximately 15 mm long and 8 mm wide, with "A7TI" engraved on one side and "5" on the other.

Axitinib Teva is available in blisters or single-dose perforated blisters (OPA/Al/PVC/Al (Al/Al)) packed in cardboard boxes.

Each pack contains 56, 60, 56 (single-dose), or 120 (single-dose) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid (Spain).

Manufacturer

Synthon Hispania, S.L.

Castelló, 1

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

The Netherlands

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600, Bulgaria

Date of the most recent review of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html.