ANASTROZOL SUN 1mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

Anastrozole SUN contains a substance called anastrozole and 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 your body makes, by blocking a natural substance (an enzyme) called 'aromatase'.

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

Do not take Anastrozole SUN:

??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 on 'Pregnancy and breast-feeding').

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Anastrozole SUN:

??if you are still having menstrual periods and have not yet gone through the menopause.

??if you are taking a medicine that contains tamoxifen or medicines that contain oestrogen (see the section on 'Taking Anastrozole SUN with other medicines').

??if you have ever had a condition that affects the strength of your bones (osteoporosis).

??if you have any liver or kidney problems.

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

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

Taking Anastrozole SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Anastrozole SUN may affect the way other medicines work, and some medicines may affect how Anastrozole SUN works.

Do not take Anastrozole SUNif you are already being treated with 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 known as an 'LHRH analogue'. This includes gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, some gynaecological conditions, and infertility.

Pregnancy and breast-feeding

Do not take Anastrozole SUN if you are pregnant or breast-feeding. Stop taking Anastrozole SUN if you become pregnant and consult your doctor.

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

Driving and using machines

Anastrozole SUN 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 SUN. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole SUN contains lactose

Anastrozole SUN 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.

Use in athletes

This medicine contains anastrozole, which may produce a positive result in doping tests.

3. How to take Anastrozole SUN

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, consult 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 water.
• You can take Anastrozole SUN before, during, or after meals.

Keep taking Anastrozole SUN 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 should not be given to children and adolescents.

If you take more Anastrozole SUN than you should:

If you take more Anastrozole SUN than you should, contact a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Anastrozole SUN:

If you forget to take a dose, just take the next dose normally.

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

If you stop taking Anastrozole SUN:

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 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 that 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 tingling sensation in the hand).

• Tingling, numbness, or prickling sensation of the skin, loss of taste.
• Diarrhoea
• Vomiting
• Changes in blood tests that show how well your liver is working.

• Thinning of the 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 the 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 itching.
• Trigger finger (a condition where one of your fingers gets stuck in a bent position).

A high level of calcium in the blood. If you experience nausea, vomiting, and thirst, tell your doctor or pharmacist or nurse as you may need to have 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 hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).

• Inflammation of small blood vessels, causing red or purple discoloration of the skin. Very rarely, symptoms of joint pain, stomach pain, and kidney pain may occur; this is known as 'Henoch-Schönlein purpura'.

Side effects with frequency not known (frequency cannot be estimated from the available data)

• Dry eyes.
• Lichenoid rash (small red or purple bumps with itching on the skin).
• Inflammation of a tendon or tendinitis (connective tissue that connects muscles to bones).
• Tendon rupture (connective tissue that connects muscles to bones).
• Memory problems.

Effects on your bones:

Anastrozole lowers the levels of female sex hormones (oestrogens) in your body. This may reduce the mineral content of your bones, making them weaker and increasing the risk of fractures. Your doctor will monitor these risks according to treatment guidelines for the management of bone conditions in post-menopausal women. You should discuss the risks and treatment options with your doctor.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

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 Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anastrozole SUN

Keep this medicine 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.

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.

Store in the original package.

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 SUN contains

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

Tablet core:

Lactose monohydrate, maize starch, povidone, microcrystalline cellulose, sodium starch glycollate (type A), colloidal anhydrous silica, magnesium stearate, talc.

Tablet coating:

Hypromellose, macrogol 400, titanium dioxide (E-171), talc.

Appearance and packaging

Anastrozole SUN 1 mg is presented as white, round, film-coated tablets.

Each blister pack contains 10 or 14 tablets.

Packet sizes: 20, 28, 30, 60, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Remedica Ltd

Limassol Industrial Estate, Aharnon Street

P.O.Box 51706, 3508, Limassol

Cyprus

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.:+34 93 342 78 90

Date of last revision of this leaflet: June 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/