AXITINIB STADA 1 mg FILM-COATED TABLETS

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Axitinib is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when other medicines (called sunitinib or cytokines) are not able to slow down the progression of the disease.

If you have any questions about how this medicine works or why you have been prescribed it, ask your doctor.

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

Do not take Axitinib Stada:

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

If you think you may be allergic, talk to your doctor.

Warnings and precautions

Talk to your doctor or nurse before taking Axitinib Stada:

• If you have high blood pressure.

Axitinib may increase your blood pressure. It is important that you have your blood pressure checked before you start taking this medicine and from time to time during treatment. If you have high blood pressure (hypertension), you may be treated with medicines that lower your blood pressure. Your doctor should make sure that you have your blood pressure under control before you start taking axitinib and during treatment with this medicine.

• If you have thyroid problems.

Axitinib may cause thyroid problems. Contact your doctor if you feel more tired than usual, feel colder than other people, or your voice becomes deeper while taking this medicine. Before treatment with axitinib, your thyroid function should be checked and from time to time while you are taking it. 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 clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Call the emergency service immediately and contact your doctor if you have symptoms such as chest pain or pressure, pain in your arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of your body, speech problems, headache, changes in vision, or dizziness while taking this medicine.

• If you have bleeding problems.

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

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

• If you have severe stomach pain (abdominal pain) or stomach pain that does not go away while taking this medicine.

Axitinib may increase the risk of developing a stomach ulcer or intestinal ulcer or the formation of fistulas (abnormal tube-like passage from one body cavity to another or to the skin). Talk to your doctor if you have severe abdominal pain while taking this medicine.

• If you are going to have surgery or if you have an open wound.

Your doctor should stop axitinib at least 24 hours before surgery, as it may affect wound healing. Treatment with this medicine should be restarted when the wound is well healed.

• If you have symptoms such as headache, confusion, seizures (epileptic fits), or changes in vision with or without high blood pressure while taking this medicine.

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

• If you have liver problems.

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

• If you have symptoms such as excessive tiredness, swelling of the abdomen, legs, or ankles, difficulty breathing, or protrusion of the neck veins while taking this medicine.

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

Use in children and adolescents

Axitinib is not recommended for people 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. Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, and herbal medicines. 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;
• nefazodone, used to treat depression.

The following medicines may decrease the effectiveness of axitinib:

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

Do nottake these medicines during treatment with axitinib. If you are taking any of them, tell your doctor, pharmacist, or nurse. Your doctor may change the dose of these medicines, change the dose of axitinib, or change to another medicine.

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

Taking Axitinib Stada with food and drinks

Do not take this medicine with grapefruit or grapefruit juice, as it may increase the risk of side 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 fetus or breastfed baby.

• 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 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 you whether to stop breastfeeding or stop treatment with axitinib.

Driving and using machines

If you feel dizzy or tired while taking axitinib, be careful when driving or using machines.

Axitinib Stada contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Axitinib Stada contains sodium

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

3. How to take Axitinib Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor, pharmacist, or nurse.

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

Swallow the tablets whole with a little water, with or without food. Take the 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 you need, contact your doctor immediately for advice. If possible, show your doctor the pack or this leaflet. You may need medical attention.

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

If you forget to take Axitinib Stada

Take the next dose at the 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. Take the next dose at the usual time.

If you stop taking Axitinib Stada

If you are not able to take this medicine as your doctor has prescribed, or if you think you no longer need it, contact your doctor immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Heart failure events. Talk to your doctor if you feel excessively tired, swelling of the abdomen, legs, or ankles, difficulty breathing, or protrusion of the neck veins.

• Blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Call the emergency service immediately and contact your doctor if you have symptoms such as chest pain or pressure, pain in your arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of your body, speech problems, headache, changes in vision, or dizziness.

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

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

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

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

Other side 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, irritation of the mouth, tongue, or throat, constipation.
• Shortness of breath, cough, hoarseness.
• Lack of energy, feeling weak or tired.
• Low activity of the thyroid gland (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.
• Pain in the joints, pain in the hands or feet.
• Lack of appetite.
• Protein in the 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 tingling sensation in the mouth.
• Hyperthyroidism (may be seen in blood tests).
• Sore throat or irritation of the nose and throat.
• Muscle pain.
• Nosebleeds.
• Itching of the skin, redness of the skin, hair loss.
• Ringing or other sounds in the ears (tinnitus).
• Decreased red blood cell count (may be seen in blood tests).
• Decreased platelet count (cells that help blood clot) (may be seen in blood tests).
• Presence of red blood cells in the urine (may be seen in urine tests).
• Changes in the levels of different substances/enzymes in the blood (may be seen in blood tests).
• Increased red blood cell count (may be seen in blood tests).
• Swelling of the abdomen, legs, or ankles, protrusion of the neck veins, excessive tiredness, difficulty breathing (signs of heart failure events).
• Fistula (abnormal connection between two body parts).
• Dizziness.
• Inflammation of the gallbladder.

Uncommon: may affect up to 1 in 100 people

• Decreased white blood cell count (may be seen in blood tests).

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Axitinib Stada

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

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date is the last day of the month shown.

Store in the original package to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is axitinib. Axitinib tablets are available in different concentrations.

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), red iron oxide (E172), triacetin.

Appearance of the Product and Package Contents

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 package contains 14, 14x1 (unit-dose), 28, 28x1 (unit-dose), 56, 56x1 (unit-dose), 60 or 60x1 (unit-dose) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory 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

Netherlands

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of the Last Revision of this Prospectus:January 2023

This Medication is Authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) with the Following Names:

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