Anastrozole Combix 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozol Combix 1 mg film-coated tablets EFG

Anastrozol

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Anastrozol Combix contains a substance called anastrozol and belongs to a group of medicines known as aromatase inhibitors. Anastrozol is used to treat breast cancer in women who are postmenopausal.

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

2. What you need to know before starting to take Anastrozol Combix

Do not take Anastrozol Combix

• if you are allergic to anastrozol or any of the other ingredients of this medicine (see section 6: Contents of the pack and further information).
• If you are pregnant or breastfeeding (see the section titled “Pregnancy and breastfeeding”).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Anastrozol Combix.

Take special care with Anastrozol Combix

Before taking Anastrozol Combix, 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.
• 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 anastrozol.

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

Taking Anastrozol Combix with 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 remedies. 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), for example, medicines containing tamoxifen. This is because these medicines may prevent anastrozol from 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 gynecological conditions, and infertility.

Pregnancy and breastfeeding

Do not take anastrozol if you are pregnant or breastfeeding. Stop treatment with anastrozol 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 anastrozol will affect your ability to drive or use tools or machinery. However, occasionally some patients may feel weak or drowsy while taking anastrozol. If this happens to you, seek advice from your doctor or pharmacist.

Anastrozol Combix contains lactose. 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 anastrozol, which may lead to a positive result in doping control tests.

3. How to take Anastrazol Combix

Follow exactly the instructions for using this medicine as given by your doctor. 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 anastrozol before, during, or after meals.

Continue taking anastrozol for as long as your doctor has prescribed it. 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 and adolescents.

If you take more Anastrozol Combix than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist, 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 Combix

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 Combix

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 Combix 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 weakening (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 of 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 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”.

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 joining muscles to bones).
• Tendon rupture (connective tissues joining 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 decrease the mineral content of your bones. They 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es.

5. Storage of Anastrozol Combix

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.

No special storage conditions are required.

Keep in the outer packaging.

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.

Medicines must not be disposed of via wastewater or household waste. Take any unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Anastrozole Combix

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

The other components (excipients) are:

• Tablet core: monohydrate lactose (lactose), povidone, sodium carboxymethyl potato starch (potato starch), magnesium stearate (E470b).
• Film coating: hypromellose (E464), macrogol, titanium dioxide (E171).

Appearance of the medicinal product and contents of the pack

Film-coated tablets, white in colour, biconvex, round, marked with "A7" on one side and smooth on the other.

PVC/PVDC/Aluminium blisters.

Each pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet was approved in July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/