Anastrozole Liderfarm 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozol Liderfarm 1 mg film-coated tablets EFG

Anastrozole

Read the entire leaflet carefully before you start taking this medicine.

• 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

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

2. Before you take Anastrozol Liderfarm

3. How to take Anastrozol Liderfarm

4. Possible side effects

5. Storage of Anastrozol Liderfarm

6. Further information

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

Anastrozol Liderfarm contains a substance called anastrozole and 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, by blocking a natural body substance (an enzyme) called "aromatase".

2. Before taking Anastrozol Liderfarm

Do not take Anastrozol Liderfarm

• if you are allergic (hypersensitive) to anastrozole or to any of the other ingredients of Anastrozol Liderfarm (see section 6: Further information).
• if you are pregnant or breastfeeding (see the section titled “Pregnancy and breastfeeding”).

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

Take special care with Anastrozol Liderfarm

Before taking Anastrozol Liderfarm, check with your doctor or pharmacist

• if you still have menstrual periods and have not reached menopause.
• if you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section titled “Use of 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 anastrozole.

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

Use of 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 have an effect on anastrozole.

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), for example, medicines containing tamoxifen. This is because these medicines may cause anastrozole to stop working 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.

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 female health (gynaecological) disorders and infertility.

Pregnancy and breastfeeding

Do not take anastrozole if you are pregnant or breastfeeding. Stop treatment with anastrozole if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

It is unlikely that anastrozole will affect your ability to drive or use any tools or machinery. However, occasionally some patients may experience weakness or drowsiness while taking anastrozole. If this happens to you, seek advice from your doctor or pharmacist.

Important information about some of the ingredients of Anastrozol Liderfarm

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 him before taking this medicine.

Use in athletes

This medicine contains anastrozole, which may result in a positive test in doping controls.

3. How to take Anastrozol Liderfarm

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

• The usual 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 anastrozole before, during, or after meals.

Continue taking anastrozol for as long as your doctor has instructed you. This is a long-term treatment and you may need to take it for several years.

Use in children

Anastrozol must not be given to children or adolescents.

If you take more Anastrozol Liderfarm than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Liderfarm

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

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 or pharmacist.

4. Possible adverse effects

Like all medicines, Anastrozol Liderfarm may cause adverse effects, although not everyone experiences them.

Very common adverse effects (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 (affect between 1 and 10 in 100 people)

• Loss of appetite
• Increased 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)
• Diarrhea
• Vomiting
• Changes in blood tests indicating how well your liver is functioning
• Hair thinning (hair loss)
• Allergic reactions (hypersensitivity), including swelling of the face, lips, or tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor)

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

Rare adverse effects (affect between 1 and 10 in 10,000 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 skin ulcers or blisters. 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 linking muscles to bones)
• Tendon rupture (connective tissues linking 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

Anastrozol 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 fractures more likely. 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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. The tablets could harm them.

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.

This medicine does not require any special storage conditions.

Store in the outer packaging.

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

6. Additional Information

Composition of Anastrozol Liderfarm

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

The other components (excipients) are:

Tablet core: lactose monohydrate (lactose), povidone K29-32, sodium starch glycolate Type A potato (potato starch), magnesium stearate (E572)

Tablet coating: Opadry White Y-1-70001 (hypromellose (E464), macrogol 400 and titanium dioxide (E171)), hypromellose (E464)

Appearance of the product and contents of the container

White to off-white, round, biconvex film-coated tablets, engraved with "A 1" on one side.

Anastrozol Liderfarm is supplied in packaging containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 summary of product characteristics 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/