Anastrozole Aurovitas 1 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Anastrozol Aurovitas 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

2. What you need to know before taking Anastrozol Aurovitas

Do not take Anastrozol Aurovitas

• If you are allergic to anastrozol 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 this medicine if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine.

• 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 Aurovitas”).
• If you have ever had a condition affecting your 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 this medicine.

If you are admitted to hospital, inform healthcare staff that you are taking this medicine.

Other medicines and Anastrozol Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you buy 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 if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines containing tamoxifen. This is because these medicines may cause this medicine to no longer work 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.

Tell 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 this medicine if you are pregnant or breastfeeding. Stop taking this medicine 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 this medicine will affect your ability to drive or use tools or machines. However, occasionally some patients may feel weak or drowsy while taking this medicine. If this happens to you, seek advice from your doctor or pharmacist.

Anastrozol Aurovitas contains lactose

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 them before taking this medicine.

Anastrozol Aurovitas contains sodium

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 Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• 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 this medicine before, during, or after meals.

Continue taking this medicine 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

This medicine must not be given to children or adolescents.

If you take more Anastrozol Aurovitas than you should

If you take 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Aurovitas

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

If you stop taking Anastrozol Aurovitas

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, 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 Aurovitas and seek urgent medical attention if you experience any of the following serious but very rare adverse 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.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common adverse effects: may affect up to 1 in 10 people

• Loss of appetite.
• Increased or elevated levels of a fatty compound 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 skin prickling, loss/absence 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.
• Bone pain.
• Vaginal dryness.
• 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 welts.
• Trigger finger (a condition in which one of the fingers of the hand remains bent).
• Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, inform your doctor, pharmacist, or nurse, as you may need 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 caused by 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".

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

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

Effects on your bones

This medicine reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. As a result, bones may become weaker and more prone to 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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. Anastrozole Aurovitas Storage

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via the sewage system or with household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol Aurovitas

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are:

Core: monohydrate lactose, sodium starch glycolate type A (from potato), povidone (K30) and magnesium stearate.

Coating: hypromellose 2910 (6 mPa·s), titanium dioxide (E171) and macrogol.

Appearance of the product and contents of the pack

Film-coated tablet.

Anastrozol is a biconvex, white, film-coated tablet marked with “A1” on one side and smooth on the other. The tablet size is approximately 6.1 mm.

This medicine is available in cartons containing PVC/aluminum blisters.

Pack sizes: 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate,

Hal Far, BBG 3000,

Birzebbugia, Malta.

Or

Generis Farmacêutica S.A.

Rua Joao De Deus, nº 19

Venda Nova, 2700-487,

Amadora, Portugal.

Or

Arrow Generiques S.A.S.

26 Avenue Tony Garnier

69007, Lyon, France.

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Portugal Anastrozol Generis

France ANASTROZOLE ARROW LAB 1 mg, comprimé pelliculé

Germany AnastroPUREN 1 mg Filmtabletten

Italy Anastrozolo Aurobindo Italia

Poland Anastrozole Eugia

Spain Anastrozol Aurovitas 1 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: September 2025

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