Arimidex 1 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Arimidex 1 mg film-coated tablets

anastrozol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Arimidex is and what it is used for

Arimidex contains a substance called anastrozole and belongs to a group of medicines known as "aromatase inhibitors". Arimidex is used to treat breast cancer in women who have undergone menopause.

Arimidex works by reducing the amount of hormones called oestrogens produced by your body, through blocking a natural body substance (an enzyme) called "aromatase".

2. What you need to know before taking Arimidex

Do not take Arimidex

• if you are allergic to anastrozole 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 Arimidex if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking Arimidex.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Arimidex:

• 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 “Taking Arimidex with 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 Arimidex.

If you are admitted to hospital, inform healthcare staff that you are taking Arimidex.

Taking Arimidex with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Arimidex may affect the action of other medicines, and some medicines may affect Arimidex.

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

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines containing tamoxifeno. This is because these medicines may cause Arimidex to stop 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 (gynecological) disorders, and infertility.

Pregnancy and breastfeeding

Do not take Arimidex if you are pregnant or breastfeeding. Discontinue Arimidex if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

It is unlikely that Arimidex will affect your ability to drive or use any tools or machinery. However, occasionally some patients may feel weakness or drowsiness while taking Arimidex. If this happens to you, seek advice from your doctor or pharmacist.

Arimidex contains lactose

Arimidex contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Arimidex contains sodium

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

3. How to take Arimidex

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 Arimidex before, during, or after meals.

Continue taking Arimidex 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.

Use in children and adolescents

Arimidex must not be given to children and adolescents.

If you take more Arimidex than you should

If you take more Arimidex than you should, contact a doctor 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 Arimidex

If you forget to take a dose, simply take your 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 Arimidex

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, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Arimidex 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 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.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common adverse effects may affect up to 1 in 10 people

• Loss of appetite.
• Increased 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 skin prickling, loss/lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests showing 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 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 urticaria.
• Trigger finger (a condition in which one of the fingers of the hand remains in a bent position).
• 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 discoloration. Very rarely, symptoms of joint, stomach, and 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

Arimidex reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. Bones may become weaker, increasing the likelihood of fractures. Your doctor will monitor these risks according to treatment guidelines for bone status 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Arimidex

Do not store above 30°C.

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. These tablets could harm them.

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

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in 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 Arimidex

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are monohydrate lactose, povidone, sodium starch glycolate from potato, magnesium stearate, hypromellose, macrogol 300 and titanium dioxide.

Appearance of the product and contents of the pack

White, round, biconvex film-coated tablets of approximately 6.1 mm, marked with an "A" on one side and 'Adx1' on the other.

Arimidex is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratoires Juvisé Pharmaceuticals
149 boulevard Bataille de Stalingrad
69100 Villeurbanne
France

Manufacturer

Haupt Pharma Muenster GmbH
Schleebrueggenkamp 15, Muenster
Nordrhein-Westfalen 48 159
Germany

AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Arimidex
Austria: Arimidex
Belgium: Arimidex
Bulgaria: Arimidex
Cyprus: Arimidex
Denmark: Arimidex
Slovenia: Arimidex 1mg filmsko obložene tablete
Spain: Arimidex 1 mg film-coated tablets
Estonia: Arimidex
Finland: Arimidex
France: Arimidex
Greece: Arimidex
Netherlands: Arimidex
Hungary: Arimidex
Iceland: Arimidex
Ireland: Arimidex
Italy: Arimidex
Latvia: Arimidex
Lithuania: Arimidex
Luxembourg: Arimidex
Malta: Arimidex
Norway: Arimidex
Poland: Arimidex
Portugal: Arimidex
United Kingdom: Arimidex
Czech Republic: Arimidex
Slovak Republic: Arimidex
Romania: Arimidex
Sweden: Arimidex

Date of the most recent review of this leaflet: July 2025

Other sources of information

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/