ANASTROZOL CINFA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Anastrozole Cinfa 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 Cinfa

Do not take Anastrozole Cinfa

• if you are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6).
• 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.

Warnings and precautions

Consult your doctor or pharmacist before taking anastrozole if:

• you are still having menstrual periods and have not yet gone through the menopause.
• you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called 'Other medicines and Anastrozole Cinfa').
• you have ever had a condition that affects the strength of your bones (osteoporosis).
• you have any problems with your liver or kidneys.

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 your doctor or the hospital staff that you are taking anastrozole.

Other medicines and Anastrozole Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because anastrozole can affect the way other medicines work, and some medicines can affect how anastrozole works.

Do not take anastrozole if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop anastrozole from working properly.
• Medicines that contain estrogen, such as hormone replacement therapy (HRT). If you are in this situation, ask your doctor or pharmacist for advice.

Consult your doctor or pharmacist if you are taking:

• A medicine called an 'LHRH analogue'. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, some gynaecological conditions and infertility.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take anastrozole if you are pregnant or breast-feeding. Stop taking anastrozole if you become pregnant and consult your doctor.

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 Cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Anastrozole Cinfa contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially 'sodium-free'.

3. How to take Anastrozole Cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose is one tablet daily.
• Try to take your tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• You can take your tablet before, during or after food.

Keep taking anastrozole for as long as your doctor or pharmacist tells you to. This is a long-term treatment and you may need to take it for several years. If you are not sure, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole Cinfa 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 contact the Poisons Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Anastrozole Cinfa

If you forget to take a dose, just take the next dose as normal.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Anastrozole Cinfa

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, this medicine can cause side effects, although not everybody gets them.

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

• A very severe skin rash with ulcers or blisters in 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'.

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

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

Common side effects (may affect up to 1 in 10 people)

• Lack of appetite.
• High levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Feeling tired.
• Carpal tunnel syndrome (tingling, pain, numbness or weakness in the hand).
• Tickling, tingling or numbness of the skin, loss of taste.
• 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).
• Muscle pain.

Uncommon side effects (may affect up to 1 in 100 people)

• Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin).
• Liver inflammation (hepatitis).
• Hives or itchy skin.
• Trigger finger (a condition where one of your fingers is bent and you cannot straighten it out).

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

Rare side effects (may affect up to 1 in 1,000 people)

• A rare skin condition with redness and blisters.
• Skin rash caused by an allergic reaction.
• Inflammation of small blood vessels which can cause red or purple spots on the skin. Very rarely, this can lead to joint pain, stomach pain and kidney problems; this is known as 'Henoch-Schönlein purpura'.

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)
• Inflammation of a tendon or tendonitis (tissues that connect muscles to bones)
• Tendon rupture (tissues that connect muscles to bones)
• Memory problems

Effects on your bones

Anastrozole lowers the levels of female sex hormones (estrogens) 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 for your bone health according to treatment guidelines for post-menopausal women. You should talk to your doctor about the risks and treatment options.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole Cinfa

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

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.

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 Cinfa 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 anhydrous, sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose (E-460), anhydrous colloidal silica and magnesium stearate.
• Coating of the tablet: Opadry white (hypromellose (E-464), titanium dioxide (E-171) and macrogol 6000).

Appearance and packaging

White, cylindrical, biconvex, film-coated tablets with the logo "1" on one face.

They are available in PVC/PVDC/Aluminium blister packs. Each pack contains 28 or 100 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:June 2025.

Detailed information on this medicine is available on the website of the Spanish Medicines Agency (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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