Anastrozole Vir 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anastrozol VIR 1 mg film-coated tablets EFG

anastrozole

Read the entire 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 personally and must not be given to others. It may harm them even if they have the same symptoms as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

Package contents and other information

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

Anastrozol Vir contains a substance called anastrozole. It 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, through blocking a naturally occurring substance (an enzyme) called "aromatase".

2. Before taking Anastrozol Vir

Do not take Anastrozol Vir

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

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Anastrozol Vir:

• 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 “Taking Anastrozol Vir with other medicines”).
• if you have ever had a condition affecting bone strength (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 Anastrozol Vir.

If you are admitted to hospital, inform healthcare staff that you are taking Anastrozol Vir.

Use of other medicines and Anastrozol Vir

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes medicines you have purchased without a prescription and herbal medicines. This is because anastrozol may affect the action of other medicines, and some medicines may affect anastrozol.

Do not take Anastrozol Vir 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 cause Anastrozol Vir to stop working properly.
• Medicines containing estrogen, such as hormone replacement therapy (HRT). If you are in any of these situations, seek advice from your doctor or pharmacist.

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

Consult 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 gynecological conditions, and infertility.

Pregnancy and breastfeeding

Do not take Anastrozol Vir if you are pregnant or breastfeeding. Stop treatment with Anastrozol Vir 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 anastrozol will affect your ability to drive or use tools or machinery. However, occasionally some patients may feel weak or drowsy while taking Anastrozol Vir. If this happens to you, seek advice from your doctor or pharmacist.

Anastrozol contains lactose

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

Anastrozol contains sodium

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

3. How to take Anastrozol Vir

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist.

• The recommended dose is one tablet daily.
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with water.
• You may take Anastrozol Vir before, during, or after meals.

Continue taking Anastrozol Vir for as long as your doctor or pharmacist has instructed. 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

Anastrozol Vir must not be given to children or adolescents.

If you take more Anastrozol Vir than you should

If you have taken more Anastrozol 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Vir

If you forget to take a dose, simply take the next dose at your 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 Vir

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

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 everyone will experience them.

Stop taking Anastrozole VIR and seek urgent medical attention if you experience any of the following very rare but serious 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 that may cause difficulty swallowing or breathing. This is known as “angioedema”.

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

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

Common adverse effects (may affect up to 1 in 10 people)

• Loss of appetite. Increase or elevated levels of a fatty substance in the blood 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 pins and needles of the skin, loss/lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests showing how well your liver is functioning.
• Hair weakening (hair loss).
• Allergic reactions (hypersensitivity), including of the face, lips or tongue.
• Bone pain.
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor).
• Muscle pain.

Uncommon adverse effects (may affect up to 1 in 100 people)

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

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

• Rare skin inflammation that may include red spots or blisters.
• 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 adverse effects (affect fewer 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 that may cause difficulty swallowing or breathing. This is known as “angioedema”.

Adverse effects with unknown frequency (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 that join muscles to bones).
• Rupture of a tendon (connective tissues that join muscles to bones).
• Memory impairment.

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

Effects on your bones

Anastrozole reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. They may become weaker, increasing the risk 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 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozol 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. The tablets could harm them.

This medicine does not require any special storage conditions.

Do not use Anastrozol Vir 1 mg after the expiry date stated on the packaging after EXP. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol VIR

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

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

Appearance of the product and contents of the pack

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

Anastrozol is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

The Netherlands

Or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The 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 the most recent review of this leaflet: June 2025

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