ANASTROZOL VIR 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Anastrozole VIR 1 mg film-coated tablets EFG

anastrozole

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.

• Keep this leaflet, as 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 and other information

1. What is Anastrozole VIR and what is it used for
2. Before you take Anastrozole VIR
3. How to take Anastrozole VIR
4. Possible side effects
5. Storing Anastrozole VIR

Contents of the pack and further information

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

Anastrozole VIR contains a substance called anastrozole. It belongs to a group of medicines called 'aromatase inhibitors'. Anastrozole is used to treat breast cancer in women who are post-menopausal.

Anastrozole works by reducing the amount of hormones called oestrogens that are produced by your body, by blocking a natural substance (an enzyme) called 'aromatase'.

2. Before you take Anastrozole VIR

Do not take Anastrozole VIR

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Anastrozole VIR:

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

If you are going into hospital, tell the medical staff that you are taking Anastrozole VIR.

Taking other medicines and Anastrozole VIR

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because anastrozole can affect the way other medicines work, and some medicines can affect the way anastrozole works.

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

• Certain medicines used to treat breast cancer (selective oestrogen receptor modulators), such as medicines that contain tamoxifen. This is because these medicines may stop Anastrozole VIR from working properly.
• Medicines that contain oestrogen, such as hormone replacement therapy (HRT). If you are in this situation, ask your doctor or pharmacist for advice.

If you are in this situation, 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 female health problems (gynaecological problems), and infertility.

Pregnancy and breast-feeding

Do not take Anastrozole VIR if you are pregnant or breast-feeding. Stop taking Anastrozole VIR 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 VIR. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole contains lactose

Anastrozole VIR 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.

Anastrozole contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Anastrozole VIR

Follow exactly the instructions given to you by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

• The recommended dose is one tablet per 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 VIR before, during, or after food.

Keep taking Anastrozole VIR for as long as your doctor or pharmacist 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 VIR should not be given to children and adolescents.

If you take more Anastrozole VIR than you should

If you have taken more Anastrozole VIR than you should, contact a doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Anastrozole VIR

If you forget to take a dose, just take the next dose as normal. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Anastrozole VIR

Do not stop taking your tablets unless your doctor tells you to.

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

4. Possible side effects

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

Stop taking Anastrozole VIR and seek urgent medical attention, if you experience any of the following serious but very rare side effects:

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

Very common side effects (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 side effects (may affect up to 1 in 10 people)

• Lack of appetite. Increased or high levels of a fatty substance in the blood called cholesterol, which would be seen in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, numbness, or weakness in the hand).
• Tingling, numbness, or prickling of the skin, loss of taste.
• Diarrhoea.
• 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 bleeding (usually in the first few weeks of treatment - if bleeding continues, talk to your doctor).
• Muscle pain.

Uncommon side effects (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).
• Inflammation of the liver (hepatitis).
• Hives or itchy skin.
• Trigger finger (a condition where one of your fingers gets stuck in a bent position).

• Trigger finger (a condition where one of your fingers gets stuck in a bent position).
• High levels of calcium in the blood. If you experience nausea, vomiting, and thirst, tell your doctor, pharmacist, or nurse, as you may need a blood test.

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

• A rare skin inflammation that may include red patches or blisters.
• A skin rash caused by an allergic reaction (this may be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels, which may cause red or purple spots on the skin. Very rarely, symptoms of joint pain, stomach pain, and kidney pain may occur; this is known as 'Henoch-Schönlein purpura'.

Very rare side effects (may affect less than 1 in 10,000 people)

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

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Dry eyes.
• Lichenoid rash (small red or purple bumps on the skin that itch).
• Tendinitis (inflammation of the tendons) or tendon rupture (tearing of the tendons).
• Memory loss.

If any of these happen to you, call an ambulance or see a doctor immediately. You may need urgent medical treatment.

Effects on your bones

Anastrozole lowers the levels of female sex hormones (oestrogens) in your body, which may cause your bones to become thinner and weaker. This may increase the risk of fractures. Your doctor will check the risks and treatment options according to the treatment guidelines for the condition of your bones in post-menopausal women. You should discuss the risks and treatment options with your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anastrozole VIR 1 mg

Keep out of the sight and reach of children. Store the tablets in a safe place where children cannot see or reach them. Your tablets could harm them.

This medicine does not require any special storage conditions.

Do not use Anastrozole VIR 1 mg after the expiry date which is stated on the carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month stated.

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 VIR contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients are in the tablet core: lactose monohydrate, sodium starch glycollate (type A), povidone (E1201), and magnesium stearate (E572).

The coating contains macrogol 400, hypromellose (E464), and titanium dioxide (E171).

Appearance and packaging

Anastrozole is a film-coated tablet, round, with the inscription "ANA" and "1" on one side.

Anastrozole is available in packs of 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II, 28923 Alcorcón (Madrid) – Spain

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

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

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

Netherlands Strakir 1 mg, filmomhulde tabletten

Spain Anastrozol VIR 1 mg, comprimidos recubiertos con película EFG

UK Anastrozole 1 mg, Film-coated Tablets

Date of last revision of this leaflet: June 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es