Anastrozole CINFA 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

anastrozol cinfa 1 mg film-coated tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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 they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What anastrozol cinfa is and what it is used for

anastrozol cinfa 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. What you need to know before starting to take anastrozol cinfa

Do not take anastrozol cinfa

• if you are allergic to anastrozol or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see the section entitled “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 cinfa

• 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 entitled “Other medicines and anastrozol cinfa”).
• if you have ever had a condition affecting the strength of your bones (osteoporosis).
• if you have any liver or kidney problems.

If you are unsure whether any of this applies to you, consult your doctor or pharmacist before taking anastrozol.

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

Other medicines and anastrozol cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you purchase 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 estrogen, 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 (gynecological) health disorders, and infertility.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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 experience weakness or drowsiness while taking anastrozol. If this occurs, seek advice from your doctor or pharmacist.

anastrozol cinfa contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

anastrozol cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take anastrozol cinfa

Follow exactly the instructions for the use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended 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 the medicine before, during, or after meals.

Continue taking anastrozol for as long as your doctor or pharmacist has instructed. This is a long-term treatment and you may need to take it for several years. If in doubt, consult your doctor or pharmacist again.

Use in children and adolescents

Anastrozol must not be given to children and adolescents.

If you take more anastrozol cinfa than you should

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

In case of overdose or accidental ingestion, contact your doctor, 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 cinfa

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 forgotten doses.

If you stop taking anastrozol cinfa

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, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking anastrozole and seek urgent medical attention if you experience any of the following very rare but serious adverse effects:

• 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”.

Very common adverse effects (may affect more than 1 in 10 patients):

• Headache.
• Hot flushes.
• Dizziness (nausea).
• Skin rash.
• Joint pain or stiffness.
• Inflammation of the joints (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common adverse effects (may affect up to 1 in 10 patients):

• Loss of appetite.
• Increase 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).
• Tingling, numbness, or pins and needles of the skin, loss or lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests indicating how well your liver is functioning.
• Hair thinning (hair loss).
• Allergic reactions (hypersensitivity), including of the face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak to your doctor).
• Muscle pain.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin).

• Inflammation of the liver (hepatitis).

• Hives or wheals.

• Trigger finger (a condition in which one of the fingers of the hand remains bent).

• Increase in the amount of calcium in the blood. If you experience nausea, vomiting, and thirst, inform your doctor, pharmacist, or nurse, as you may need a blood test.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Rare skin inflammation that may include red spots or blisters.
• Skin rash caused by 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”.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Dry eyes
• 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

Effects on your bones

Anastrozole 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 may be 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.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Anastrozol cinfa storage

Keep this medicine out of the sight and reach of children.

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.

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

6. Contents of the pack and other information

Composition of anastrozol cinfa

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

• The other components are:

• Tablet core: monohydrate lactose, anhydrous lactose, sodium carboxymethylstarch (type A) (from potato), microcrystalline cellulose (E-460), colloidal anhydrous silica, and magnesium stearate.

• Tablet coating: Opadry white (hypromellose (E-464), titanium dioxide (E-171), and macrogol 6000).

Appearance of the product and contents of the pack

White, cylindrical, biconvex, film-coated tablets with the logo “1” on one side.

Presented in PVC/PVDC/Aluminum blisters. Each pack contains 28 or 100 tablets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: June 2025.

Detailed 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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69384/P_69384.html

QR code to: https://cima.aemps.es/cima/dochtml/p/69384/P_69384.html