Axitinib STADA 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Axitinib Stada 1 mg film-coated tablets EFG

Axitinib Stada 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, pharmacist, or nurse.
• 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, talk to your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

Axitinib is indicated for the treatment of advanced renal cell cancer (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, consult your doctor.

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

Do not take Axitinib Stada:

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

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

Warnings and precautions

Consult your doctor or nurse before taking Axitinib Stada:

• If you have high blood pressure.

Axitinib can increase blood pressure. It is important that you monitor your blood pressure before starting treatment with 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 during treatment with this medicine.

• If you have thyroid gland problems.

Axitinib can cause thyroid gland problems. Contact your doctor if you feel unusually tired, are frequently colder than others, or your voice becomes deeper while taking this medicine. Thyroid function should be monitored before treatment with axitinib 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 being treated with this medicine.

• If you suffer from bleeding disorders.

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

• If you have or have had an aneurysm (weakening and bulging of a blood vessel wall) 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 connecting one internal cavity to another or to the skin). Consult your doctor if you experience severe abdominal pain while being treated with 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 affect 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. These may be signs of a rare neurological adverse 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 fatigue, abdominal swelling, swelling of the legs or ankles, difficulty breathing, or prominent neck veins (distended neck veins).

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

Use in children and adolescents

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

Other medicines and Axitinib Stada

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 adverse 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.

The following medicines may reduce the effectiveness of axitinib:

• rifampicin, rifabutin, or rifapentine, used to treat tuberculosis (TB);
• dexamethasone, a steroid medicine prescribed for the treatment of various conditions, some of which are serious;
• phenytoin, carbamazepine, or phenobarbital, antiepileptic medicines used to prevent seizures or epileptic fits;
• St John’s wort (Hypericum perforatum), a herbal remedy used to treat depression.

Do 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, change 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 Stada 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 could 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 of this medicine, use a reliable method of contraception to prevent pregnancy.

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

Driving and using machines

If you experience dizziness and/or feel tired while being treated with axitinib, exercise particular caution when driving or operating machinery.

Axitinib Stada contains lactose

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

Axitinib Stada contains sodium

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

3. How to take Axitinib Stada

Follow exactly your doctor's instructions for taking this medicine. If you are unsure, consult your doctor, pharmacist, or nurse again.

The recommended dose is 5 mg twice daily. Your doctor may later 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.

If you take more Axitinib Stada 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 medicine and the amount ingested.

If you forget to take Axitinib Stada

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 Stada

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

If you stop taking Axitinib Stada

If you are unable to take this medicine as prescribed by your doctor, or if you 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 everybody will experience them.

Some adverse effects may 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 taking Axitinib Stada”):

• Heart failure events. Consult your doctor if you experience excessive tiredness, swelling of the abdomen, legs or ankles, shortness of breath, 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 have 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 have any of these symptoms or experience a serious bleeding problem during treatment with axitinib: black or tarry stools, coughing up blood or bloody sputum, or changes in mental status.

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

• Severe increase in blood pressure (hypertensive crisis). Consult 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 fits), 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, sore mouth, tongue or throat, constipation.
• Shortness of breath, cough, hoarseness.
• Lack of energy, feeling weak or tired.
• Low thyroid gland activity (may 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 (may be seen in urine tests).
• Weight loss.
• Headache, altered taste 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 (may 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).
• Decrease in red blood cell count (may be seen in blood tests).
• Decrease in blood platelet count (cells that help blood clotting) (may be seen in blood tests).
• Presence of red blood cells in urine (may be seen in urine tests).
• Changes in levels of different substances/enzymes in the blood (may be seen in blood tests).
• Increase in red blood cell count (may 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

• Decrease in white blood cell count (may 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 (aneurysms and arterial dissections).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Axitinib Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Do not use this medicine if it is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, 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

• The active substance is axitinib. Axitinib tablets are available in different strengths.

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

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

• The other components are microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), iron oxide red (E172), triacetin.

Appearance of the product and contents of the pack

Axitinib Stada 1 mg film-coated tablets are red, round, with “A7TI” engraved on one side and “1” on the other.

Axitinib Stada 5 mg film-coated tablets are red, oval, with “A7TI” engraved on one side and “5” on the other.

Axitinib Stada is available in blisters or perforated unit-dose blisters. Each pack contains 14, 14x1 (unit dose), 28, 28x1 (unit dose), 56, 56x1 (unit dose), 60 or 60x1 (unit dose) film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of the most recent revision of this leaflet: January 2023

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Up-to-date and 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/.