ANASTROZOL LIDERFARM 1 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozole Liderfarm 1 mg film-coated tablets EFG

Anastrozole

Read all of this leaflet carefully before you start taking this medicine.

• 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

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

5 Storage of Anastrozole Liderfarm

1. Further information

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

Anastrozole Liderfarm 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 have reached the menopause.

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 Liderfarm

Do not take Anastrozole Liderfarm

• if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Anastrozole Liderfarm (see section 6: Further information).
• if you are pregnant or breast-feeding (see the section called “Pregnancy and breast-feeding”).

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

Take special care with Anastrozole Liderfarm

Before taking Anastrozole Liderfarm, check with your doctor or pharmacist

• 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 “Using 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.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal medicines. This is because anastrozole may affect the action of other medicines, and some medicines may affect anastrozole.

Do not take Anastrozole Liderfarm 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.

Consult 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, certain gynaecological conditions and infertility.

Pregnancy and breast-feeding

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

Important information about some of the ingredients of Anastrozole Liderfarm

This medicine 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 Liderfarm

Follow exactly the instructions given to you by your doctor. Consult your doctor or pharmacist if you are unsure.

• The usual 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 before, during or after meals.

Keep taking anastrozole 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.

Use in children

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole Liderfarm than you should

If you take more anastrozole 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 on +34 91 562 04 20, stating the name and amount of the medicine taken.

If you forget to take Anastrozole Liderfarm

If you forget to take a dose, just 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 Liderfarm

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 or pharmacist.

4. Possible side effects

Like all medicines, Anastrozole Liderfarm can cause side effects, although not everybody gets them.

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

• Headache.
• Flushes.
• Feeling sick (nausea).
• Rash.
• Pain or stiffness in the joints.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common side effects (affect between 1 and 10 people in 100)

• Loss of appetite.
• High levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, numbness, weakness in parts of the hand).
• 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).

Uncommon side effects (affect between 1 and 10 people in 1,000)

• Changes in special blood tests that show how well your liver is working (gamma-GT and bilirubin).
• Liver inflammation (hepatitis).
• Hives or itching.
• Trigger finger (a condition in which one of your fingers gets stuck in a bent position).

Rare side effects (affect between 1 and 10 people in 10,000)

• Rare inflammation of the skin that may include redness 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, this may cause symptoms of joint pain, stomach pain and kidney problems; this is known as “Henoch-Schönlein purpura”.

Very rare side effects (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 eye
• Lichenoid rash (small, red or purple bumps on the skin that are itchy)
• Tendinitis (inflammation of the tendons, which connect muscles to bones)
• Tendon rupture (tearing of the tendons, which connect muscles to bones)
• Memory loss

If any of these happen to you, call an ambulance or see a doctor straight away. 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 bone condition in postmenopausal women. You should discuss the risks and treatment options with your doctor.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Anastrozole Liderfarm

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.

This medicine does not require any special storage conditions.

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. Further information

What Anastrozole Liderfarm contains

The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.

The other ingredients are:

Core of the tablet:lactose monohydrate (lactose), povidone K29-32, sodium starch glycolate Type A potato starch (potato starch), magnesium stearate (E572)

Coating of the tablet:Opadry White Y-1-70001 (hypromellose (E464), macrogol 400 and titanium dioxide (E171)), hypromellose (E464)

Appearance and packaging

White or almost white, round and biconvex tablets with the engraving “A 1” on one side.

Anastrozole Liderfarm is available in packs of 28 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Farmaldier, S.A.

C/ Aragoneses, 15

28108 Pol. Ind. Alcobendas

Madrid (Spain)

Manufacturer

Toll Manufacturing Services, S.L.

Aragoneses, nº2

28108 Alcobendas (Madrid)

This leaflet was approved in July 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) http://www.aemps.gob.es/