Anastrozole Viatris 1 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Anastrozol Viatris 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Anastrozol Viatris contains a substance called anastrozole and belongs to a group of medicines known as "aromatase inhibitors". Anastrozole is used to treat breast cancer in women who are postmenopausal.

Anastrozole works by reducing the amount of hormones called estrogens produced by your body, by blocking a natural body substance (an enzyme) called "aromatase".

2. What you need to know before starting Anastrozol Viatris

Do not take Anastrozol Viatris:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Anastrozol Viatris.

• If you still have menstrual periods and have not yet reached menopause.
• If you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section titled “Other medicines and Anastrozol Viatris”).
• If you have ever had a condition affecting the strength of your bones (osteoporosis).
• If you have any liver or kidney problems.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking anastrozole.

If you are admitted to hospital, inform healthcare professionals that you are taking anastrozole.

Other medicines and Anastrozol Viatris

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

This includes medicines obtained without a prescription and herbal remedies. This is because anastrozole may affect the action of other medicines, and some medicines may affect anastrozole.

Do not take anastrozole if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example, medicines containing tamoxifen. This is because these medicines may prevent anastrozole from working properly.

• Medicines containing estrogens, such as hormone replacement therapy (HRT).

If you are in any of these situations, seek advice from your doctor or pharmacist.

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

If you are in any of these situations, seek advice from your doctor or pharmacist.

Talk to your doctor or pharmacist if you are taking the following:

• A medicine known as an “LHRH analogue”. This includes gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, certain female (gynaecological) health conditions, and infertility.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that anastrozole will affect your ability to drive or operate tools or machinery. However, occasionally some patients may experience weakness or drowsiness while taking anastrozole. If this happens to you, seek advice from your doctor or pharmacist.

Anastrozol Viatris contains lactose and sodium

This medicine contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Anastrozol Viatris

Follow exactly the instructions for the administration of anastrozole as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet daily (1 mg of anastrozole).
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with water.
• You may take anastrozole before, during, or after meals.

Continue 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 in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozole must not be given to children and adolescents.

If you take more Anastrozol Viatris than you should

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

If you forget to take Anastrozol Viatris

If you forget to take a dose, simply take the next dose at the usual time.

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

If you stop taking Anastrozol Viatris

Do not stop taking the tablets unless instructed by your doctor.

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

4. Possible adverse effects

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

If you experience any of the following adverse reactions, stop taking anastrozole immediately and contact your doctor right away or go to the nearest hospital emergency department:

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

• Inflammation of the liver (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):

• Skin rash due to hypersensitivity (this may be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels causing red or purple skin discoloration. Very rarely, symptoms such as joint, stomach, or kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

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

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

Other adverse effects include:

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

• Headache.
• Hot flushes.
• Dizziness (nausea).
• Skin rash.
• Joint pain or stiffness.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

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

• Loss of appetite.
• Increased or elevated levels of a blood fat compound known as cholesterol, which would be detected in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in areas of the hand).
• Tingling, numbness, or skin prickling, loss/lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests showing how well your liver is functioning.
• Hair thinning (hair loss).
• Allergic reactions (hypersensitivity) including face, lips, or tongue swelling.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor).
• Muscle pain.

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

• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin).
• Hives or welts.
• Elevated levels of calcium in the blood. If you experience nausea, vomiting, and thirst, inform your doctor or pharmacist, as you may require blood tests.
• Trigger finger (a condition in which one of the fingers of the hand remains bent).

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

• Rare skin inflammation that may include red spots or blisters, known as erythema multiforme.

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

• Dry eye
• Lichenoid eruption (small red or purple itchy bumps on the skin)
• Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones)
• Tendon rupture (connective tissues linking muscles to bones)
• Memory impairment

Effects on your bones

Anastrozol reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. Bones may become weaker, increasing the likelihood of fractures. Your doctor will monitor these risks according to treatment guidelines for bone health in postmenopausal women. You should discuss the risks and treatment options with your doctor.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Anastrozol 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 stated on the packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, 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 Anastrozol Viatris

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

The other components of the tablet core are monohydrate lactose (see section 2 “Anastrozol Viatris contains lactose and sodium”), sodium carboxymethyl starch from potato, povidone (E1201) and magnesium stearate (E572).

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

Appearance of Anastrozol Viatris and contents of the pack

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

Anastrozol is marketed in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets and in hospital blisters of 28, 50, 84, 98, 300 or 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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
The 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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Anastrozol Viatris 1 mg Filmtabletten
Spain: Anastrozol Viatris 1 mg comprimidos recubiertos con película EFG
France: Anastrozole Mylan 1 mg, comprimé pelliculé
Ireland: Agerdex 1 mg film-coated tablets
Italy: Anastrozolo Mylan Generics
The Netherlands: Anastrozol Viatris 1 mg, filmomhulde tabletten
Portugal: Anastrozol Mylan
United Kingdom: Anastrozole 1 mg Film-coated Tablet
Czech Republic: Anastrozol Viatris

Date of the most recent review of this leaflet: July 2025

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