Anastrozole Normon 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anastrozol NORMON 1 mg film-coated tablets EFG

Anastrozol

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, and you should 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 adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Anastrozol NORMON 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 body substance (an enzyme) called "aromatase".

2. What you need to know before starting Anastrozol NORMON

Do not take Anastrozol NORMON

• 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 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 anastrozol

• if you still have menstrual periods and have not yet reached menopause.
• if you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section titled “Using other medicines”).
• 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.

Other medicines and anastrozol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you have purchased without a prescription and herbal medicines. This is because anastrozol may affect the activity 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 tamoxifeno. 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.

Inform 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 health (gynaecological) disorders and infertility.

Pregnancy, breastfeeding and fertility

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 any 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.

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

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

Important information for athletes

Athletes are advised that this medicine contains anastrozol, a substance that may lead to a positive analytical doping test result.

3. How to take Anastrozol NORMON

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, 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 anastrozole before, during, or after meals.

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

Use in children and adolescents

Anastrozole must not be given to children and adolescents.

If you take more Anastrozol 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, contact your doctor or pharmacist immediately 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 NORMON

If you forget to take a dose, simply take the next dose as usual.

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

If you stop treatment with Anastrozol NORMON

Do not stop taking your tablets unless instructed by your doctor.

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 serious but very rare side effects:

• An extremely 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, which may cause difficulty swallowing or breathing. This is known as "angioedema".

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

• 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 people)

• Loss of appetite.
• Increased or high 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.
• Diarrhoea.
• 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 few weeks of treatment – if bleeding continues, speak with your doctor).
• Muscle pain.

Uncommon adverse effects (may affect up to 1 in 100 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).
• 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 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 discolouration. 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 eye.
• Lichenoid eruption (small red or purple itchy bumps on the skin).
• Inflammation of a tendon or tendinitis (connective tissues that join muscles to bones).
• Tendon rupture (connective tissues that join muscles to bones).
• Memory impairment.

Effects on your bones

Anastrozole reduces levels of hormones called oestrogens in your body. This may reduce the mineral content of your bones. Bones may become weaker and fractures 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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: www.notificaram.es

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

5. Storage of Anastrozol 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. The tablets could harm them.

Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Keep in the outer packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 NORMON

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

The other components (excipients) are:

Tablet core: lactose monohydrate (lactose), povidone (E1201), sodium carboxymethyl starch from potato (Type A), and magnesium stearate (E572).

Film-coating components: hypromellose (E464), macrogol 6000, titanium dioxide (E171), and talc.

Appearance of the product and contents of the pack

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

Anastrozol NORMON is available 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 the most recent revision of this leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/