ANASTROZOL AUROVITAS 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

This medicine contains the active substance anastrozole and belongs to a group of medicines called “aromatase inhibitors”. This medicine is used to treat breast cancer in women who are post-menopausal.

This medicine works by reducing the amount of hormones called oestrogens that your body makes, by blocking a natural substance (an enzyme) called “aromatase”.

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

Do not take Anastrozole Aurovitas

• 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 this medicine if you are in any of the situations listed above. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start taking this medicine.

• If you are still having periods and have not yet reached the menopause.
• If you are taking a medicine that contains tamoxifen or medicines that contain oestrogen (see the section called “Other medicines and Anastrozole Aurovitas”).
• 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, talk to your doctor or pharmacist before taking this medicine.

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

Other medicines and Anastrozole Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 how anastrozole works.

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

• Certain medicines used to treat breast cancer (selective oestrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop anastrozole from working properly.
• Medicines that contain oestrogen, such as hormone replacement therapy (HRT).

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

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

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

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breast-feeding. Stop taking this medicine if you become pregnant and talk to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Anastrozole Aurovitas contains lactose

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

Anastrozole Aurovitas contains sodium

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

3. How to take Anastrozole Aurovitas

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

• The recommended dose is one tablet daily.
• Try to take your tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• You can take this medicine before, during or after food.

Keep taking this medicine 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, talk to your doctor or pharmacist.

Use in children and adolescents

This medicine should not be given to children and adolescents.

If you take more Anastrozole Aurovitas than you should

If you take more anastrozole than you should, talk to a doctor or go to a hospital straight away.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or contact the National Poison Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Anastrozole 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 a forgotten dose.

If you stop taking Anastrozole Aurovitas

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

If you have any further questions on the use of this medicine, 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 Aurovitas and seek urgent medical attention if you experience any of the following rare but serious side effects.

• A 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 may cause difficulty in swallowing or breathing. This is known as “angioedema”.

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

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

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

• Lack of appetite.
• High levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Sleepiness.
• Carpal tunnel syndrome (tingling, pain, numbness or weakness in the hand).
• Tingling, numbness or weakness in 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 dryness.
• 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).
• Liver inflammation (hepatitis).
• Hives or itchy skin.
• 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, talk to your doctor or pharmacist as you may need a blood test.

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

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

Effects on your bones

This medicine reduces the levels of the hormone oestrogen in your body, which may reduce the mineral content of your bones. This may make them weaker and more likely to break. Your doctor will monitor these risks according to treatment guidelines for the management of bone conditions in post-menopausal 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 Pharmacovigilance 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. Storage of Anastrozole Aurovitas

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

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.

This medicine does not require any special storage conditions.

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 other information

What Anastrozole Aurovitas contains

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

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

Coating: hypromellose 2910 (6mPas), titanium dioxide (E171) and macrogol.

Appearance and packaging

Film-coated tablet.

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

This medicine is available in packs of 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Not all 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.

You can ask for more information about this medicine from the 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 Anastrozole Generis

France ANASTROZOLE ARROW LAB 1 mg, film-coated tablet

Germany AnastroPuren 1 mg film-coated tablets

Italy Anastrozole Aurobindo Italia

Poland Anastrozole Eugia

Spain Anastrozole Aurovitas 1 mg film-coated tablets EFG

Date of last revision of this leaflet:April 2021

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)