ANASTROZOL COMBIX 1 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

Anastrozole Combix 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 estrogens that are produced by your body, by blocking a natural substance (an enzyme) called “aromatase”.

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

Do not take Anastrozole Combix

• if you are allergic to anastrozole or any of the other ingredients of this medicine (see section 6: Contents of the pack and other 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 above situations. If you are not sure, consult your doctor or pharmacist before taking anastrozole.

Warnings and precautions

Consult your doctor or pharmacist before starting Anastrozole Combix.

Be especially careful with Anastrozole Combix

Before taking Anastrozole Combix, check with your doctor or pharmacist

• if you are still having menstrual periods and have not yet reached the menopause.
• if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (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 into hospital, tell the medical staff that you are taking anastrozole.

Using Anastrozole 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 medicines. This is because anastrozole may affect the action of other medicines, and some medicines may affect anastrozole.

Do not take Anastrozole if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as medicines that contain tamoxifen. This is because these medicines may make anastrozole less effective.
• Medicines that contain estrogen, 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 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 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.

Anastrozole Combix contains lactose. 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 Combix

Follow exactly the instructions of your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

• The usual dose is one tablet per day.
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with 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 Combix 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 or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Anastrozole Combix

If you forget to take a dose, simply 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 Combix

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 Combix can cause side effects, although not everybody gets them.

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

• 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 weakness in parts of the hand).
• Diarrhea.
• 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).
• Inflammation of the liver (hepatitis).
• Hives or itching.
• Trigger finger (a condition where one of the fingers of the hand becomes stuck in a bent position).

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

• A rare skin inflammation that may include red patches or blisters.
• A skin rash caused by hypersensitivity (this may be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels, causing red or purple discoloration of the skin. Very rarely, this may be accompanied by 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 that may cause difficulty swallowing or breathing. This is known as “angioedema”.

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

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

If any of these happen to you, call an ambulance or see a doctor immediately.

You may need urgent medical treatment.

Effects on your bones

Anastrozole reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones, making them weaker and more likely to break. Your doctor will monitor these risks according to the treatment guidelines for the condition of bones in post-menopausal women. You should discuss the risks and treatment options with your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) via their website: www.notificaRAM.es.

5. Storage of Anastrozole 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. Your tablets could harm them.

No special storage conditions are required.

Store in the outer packaging

Do not use this medicine after the expiry date which is stated on the pack after “EXP”. The expiry date is the last day of the month shown.

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 Combix contains

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

The other ingredients (excipients) are:

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

Appearance and packaging

White, biconvex, round film-coated tablets, marked with “A7” on one face and smooth on the other.

PVC/PVDC/Aluminum blisters.

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/