ANASTROZOL VIATRIS 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Anastrozole Viatris 1 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Anastrozole Viatris and what is it used for

Anastrozole Viatris contains a substance called anastrozole and belongs to a group of medicines called 'aromatase inhibitors'. Anastrozole is used to treat breast cancer in women who are in the menopause.

Anastrozole works by reducing the amount of hormones called estrogens that are produced in your body. It does this by blocking a natural substance (an enzyme) called 'aromatase'.

2. What you need to know before you take Anastrozole Viatris

Do not take Anastrozole Viatris:

• If you are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breast-feeding (see the section called “Pregnancy and breast-feeding”).

Do not take anastrozole if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking anastrozole.

Warnings and precautions

Consult your doctor or pharmacist before taking Anastrozole Viatris.

• If you are still having your periods and have not yet entered the menopause.
• If you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called “Other medicines and Anastrozole Viatris”).
• If you have ever had a condition that affects the strength of your bones (osteoporosis).
• If you have any problems with your liver or kidneys.

If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking anastrozole.

If you are going to have an operation, tell the doctor or nurse that you are taking anastrozole.

Other medicines and Anastrozole Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines that you have bought without a prescription and herbal medicines. This is because anastrozole can affect the way other medicines work and some medicines can have an effect on anastrozole.

Do not take anastrozole if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as tamoxifen. This is because these medicines may stop anastrozole from working properly.

• Medicines that contain estrogen, such as hormone replacement therapy (HRT).

If you are in any of these situations, ask your doctor or pharmacist for advice.

This is because these medicines may stop anastrozole from working properly.

If you are in any of these situations, ask your doctor or pharmacist for advice.

Consult your doctor or pharmacist if you are taking any of the following:

• A medicine called an “LHRH analogue”. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, some gynecological conditions and infertility.

Pregnancy and breast-feeding

Do not take anastrozole if you are pregnant or breast-feeding. Stop taking anastrozole if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Anastrozole is unlikely to affect your ability to drive or use any tools or machines. However, occasionally some patients may feel weak or sleepy while taking anastrozole. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole Viatris contains lactose and sodium

This medicine contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Anastrozole Viatris

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

• The recommended dose is one tablet (1 mg of anastrozole) once a day.
• Try to take your tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• You can take anastrozole before, during or after food.

Keep taking anastrozole for as long as your doctor tells you to. This is a long-term treatment and you may need to take it for several years. If you are not sure, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole Viatris than you should

If you have taken more anastrozole than you should, contact your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 5620420, indicating the medicine and the amount taken.

If you forget to take Anastrozole Viatris

If you miss a dose, simply take the next dose as normal.

Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Anastrozole Viatris

Do notstop taking the tablets unless your doctor tells you to.

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

4. Possible side effects

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

If you get any of the following serious side effects, stop taking anastrozole and contact your doctor immediately or go to the casualty department at your nearest hospital:

Uncommon (may affect up to 1 in 100 people):

• Liver inflammation (hepatitis) with nausea, vomiting, loss of appetite, fever, itching, yellowing of the skin and eyes, pale stools or dark urine.

Rare (may affect up to 1 in 1,000 people):

• Severe skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).
• Inflammation of small blood vessels, which can cause red or purple spots on the skin. Very rarely, this can be associated with joint pain, stomach pain and kidney problems; this is known as “Henoch-Schönlein purpura”.

Very rare (may affect up to 1 in 10,000 people):

• A very severe skin rash with ulcers or blisters in the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat, which can cause difficulty in swallowing or breathing. This is known as “angioedema”.

Other side effects include:

Very common (may affect more than 1 in 10 people):

• Headache.
• Hot flushes.
• Feeling sick (nausea).
• Rash.
• Pain or stiffness in the joints.
• Inflammation of the joints (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common (may affect up to 1 in 10 people):

• Loss of appetite.
• High levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Feeling sleepy.
• Carpal tunnel syndrome (tingling, pain, numbness or weakness in the hand).
• Tingling, numbness or prickling sensation of the skin, loss of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is working.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity) including face, lips or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually in the first few weeks of treatment - if bleeding continues, talk to your doctor).
• Muscle pain.

Uncommon (may affect up to 1 in 100 people):

• Changes in special blood tests that show how well your liver is working (gamma-GT and bilirubin).
• Hives or itching.
• High levels of calcium in the blood. If you have nausea, vomiting and thirst, you should tell your doctor or pharmacist as you may need a blood test.
• Trigger finger (a condition in which one of your fingers gets stuck in a bent position).

Rare (may affect up to 1 in 1,000 people):

• A rare skin condition that can include red patches or blisters, known as erythema multiforme.

Not known (frequency cannot be estimated from the available data):

• Dry eye
• Lichenoid rash (small red or purple bumps on the skin that itch)
• Tendon inflammation or tendonitis (tissues that connect muscles to bones)
• Tendon rupture (tissues that connect muscles to bones)
• Memory problems

Effects on your bones

Anastrozole lowers the levels of female sex hormones (estrogens) in your body. This may reduce the mineral content of your bones. This may make them weaker and more likely to break. Your doctor will check the risks and treatment options for your bones according to treatment guidelines for postmenopausal women. You should talk to your doctor about the risks and treatment options.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole Viatris

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

What Anastrozole Viatris contains

The active substance is anastrozole. One tablet contains 1 mg of anastrozole.

The other ingredients in the tablet core are lactose monohydrate (see section 2 “Anastrozole Viatris contains lactose and sodium”), potato starch, povidone (E1201) and magnesium stearate (E572).

The ingredients in the tablet coating are macrogol, hypromellose (E464) and titanium dioxide (E171).

Appearance of Anastrozole Viatris and contents of the pack

Anastrozole Viatris 1 mg is a film-coated tablet, round and marked with the inscription “ANA” and “1” on one side.

Anastrozole is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets and in hospital blister packs of 28, 50, 84, 98, 300 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Synthon Hispania, S.L.

C/ Castelló, 1 - Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13,

Ireland

or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1

Hungary

or

Mylan UK Healthcare Limited

Building 20 Station Close

Potters Bar

EN6 1TL

United Kingdom

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria Anastrozol Viatris 1 mg Filmtabletten

Spain Anastrozol Viatris 1 mg film-coated tablets EFG

France Anastrozole Mylan 1 mg, film-coated tablet

Ireland Agerdex 1 mg film-coated tablets

Italy Anastrozolo Mylan Generics

Netherlands Anastrozol Viatris 1 mg, film-coated tablets

Portugal Anastrozol Mylan

United Kingdom Anastrozole 1 mg Film-coated Tablet

Czech Republic Anastrozol Viatris

Date of last revision of this leaflet:July 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es/