ANASTROZOLE NORMON 1 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Anastrozole NORMON 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 is Anastrozole NORMON and what is it used for
2. What you need to know before you take Anastrozole NORMON
3. How to take Anastrozole NORMON
4. Possible side effects

5 Storage of Anastrozole NORMON

1. Contents of the pack and further information

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

Anastrozole NORMON 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 NORMON

Do not take Anastrozole NORMON

• 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 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 to take anastrozole

• if you still have 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 to have an operation, tell the doctor that you are taking anastrozole.

Other medicines and anastrozole

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 anastrozole.

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 any of these situations, ask your doctor or pharmacist for advice.

Tell your doctor or pharmacist if you are taking any of the following:

• A medicine known as an “LHRH analogue”. This includes goserelin, leuprorelin, buserelin and triptorelin. These medicines are used to treat breast cancer, some gynaecological conditions and infertility.

Pregnancy, breast-feeding and fertility

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.

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

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

Important information for athletes

Athletes are advised that this medicine contains anastrozole, a component that may result in a positive doping control test.

3. How to take Anastrozole NORMON

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• Try to take your tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• You can take anastrozole 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, ask your doctor or pharmacist.

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole NORMON than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service on +34 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Anastrozole NORMON

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

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

If you stop taking Anastrozole NORMON

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 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 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.
• Sleepiness.
• Carpal tunnel syndrome (tingling, pain, numbness or coldness in parts of the hand).
• Pins and needles, 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 itching.
• Trigger finger (a condition in which one of your fingers gets stuck in a bent position).
• High levels 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 inflammation that may include red patches or blisters.
• A skin rash caused by an allergic reaction (this may be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels, which may cause red or purple discoloration of the skin. Very rarely, this can be accompanied by joint pain, stomach pain and kidney problems; this is known as “Henoch-Schönlein purpura”.

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

• Dry eye
• Lichenoid rash (small, reddish-purple bumps on the skin that itch)
• Tendon inflammation or tendonitis (connective tissue that connects muscles to bones)
• Tendon rupture (connective tissue that connects muscles to bones)
• Memory problems

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 less strong and more likely to break. Your doctor will monitor these risks according to treatment guidelines for the bone condition in post-menopausal women. You should discuss the risks and treatment options with your doctor.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole NORMON

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.

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.

No special storage conditions are required.

Store in the original package.

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 further information

Composition of Anastrozole NORMON

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), povidone (E1201), sodium starch glycollate (Type A) and magnesium stearate (E572).

Components of the tablet coating: hypromellose (E464), macrogol 6000, titanium dioxide (E171) and talc.

Appearance and packaging

Film-coated tablets, round, biconvex, white or almost white.

Anastrozole NORMON is presented in blister packs containing 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – Tres Cantos 28760 - Madrid (SPAIN)

Date of last revision of this leaflet: June 2025

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