Arimidex

Package Leaflet: Information for the User

Arimidex, 1 mg, film-coated tablets

Anastrozole

Read all of this leaflet carefully before 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Arimidex is and what it is used for
• 2. Before you take 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

Anastrozole, the active substance of Arimidex, belongs to a group of medicines called aromatase inhibitors. Arimidex is used to treat breast cancer in post-menopausal women. Arimidex works by inhibiting the action of an enzyme called aromatase, which is involved in the synthesis of female sex hormones, such as estrogen. This happens by blocking the action of the substance (enzyme) called aromatase.

2. Before you take Arimidex

When not to take Arimidex

• 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 section "Pregnancy and breast-feeding").

If any of the above applies to you, do not take Arimidex. If you are in any doubt, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Arimidex, tell your doctor or pharmacist if:

• you are still having menstrual periods (have not yet reached menopause);
• you are taking a medicine that contains tamoxifen or estrogen (see "Arimidex and other medicines");
• you have ever had a condition that affects the strength of your bones (osteoporosis);
• you have kidney or liver disease.

If you are in any doubt, consult your doctor or pharmacist before taking Arimidex. If you are admitted to hospital, inform the medical staff that you are taking Arimidex.

Arimidex and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription and herbal preparations, as Arimidex may affect the way they work, and some medicines may affect the way Arimidex works. Do not take Arimidex if you are already taking any of the following medicines:

• certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as tamoxifen, as Arimidex may stop working properly;
• medicines that contain estrogen, such as hormone replacement therapy (HRT). If this applies to you, consult your doctor or pharmacist.

Tell your doctor if:

• you are taking any luteinizing hormone-releasing hormone (LHRH) analogue, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breast-feeding

Do not take Arimidex if you are pregnant or breast-feeding. If you become pregnant while taking Arimidex, stop taking it and consult your doctor. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Arimidex is unlikely to affect your ability to drive or use machines. However, some people may experience drowsiness or weakness while taking Arimidex. If this happens to you, consult your doctor or pharmacist.

Arimidex contains lactose

This medicine contains sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium content of Arimidex

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Arimidex

Always take Arimidex exactly as your doctor or pharmacist has told you. If you are in any doubt, consult your doctor or pharmacist.

• The recommended dose of Arimidex is one tablet once a day.
• Take the tablet at the same time every day.
• Swallow the tablet whole with water.
• Arimidex can be taken with or without food.

Take Arimidex for as long as your doctor or pharmacist tells you to. Treatment with Arimidex is usually long-term and may last for several years. If you are in any doubt, consult your doctor or pharmacist.

Use in children and adolescents

Arimidex should not be used in children and adolescents.

Overdose

If you take more Arimidex than you should, contact your doctor immediately.

Missed dose

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Do not stop taking Arimidex without consulting your doctor. If you have any further questions, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Arimidex can cause side effects, although not everybody gets them.

If you experience any of the following serious but very rare side effects, stop taking Arimidex and contact your doctor immediately:

• severe skin reactions with blisters or peeling of the skin, known as Stevens-Johnson syndrome;
• allergic reactions (hypersensitivity) with swelling of the throat and tongue, which may cause difficulty in swallowing and breathing, known as angioedema.

Very common (affects more than 1 in 10 people):

• headache
• hot flushes
• nausea
• rash
• joint pain or stiffness
• arthritis
• weakness
• osteoporosis (thinning of the bones)
• depression

Common (affects 1 to 10 people in 100):

• loss of appetite
• increased cholesterol levels (fatty substance) in the blood (shown by blood tests)
• drowsiness
• carpal tunnel syndrome (tingling, pain, numbness, or weakness in the hand)
• tingling, numbness, or prickling sensation in the skin, loss of taste
• diarrhea
• vomiting
• changes in blood tests that show how the liver is working (liver function tests)
• hair thinning (hair loss)
• allergic reactions (hypersensitivity) on the face, lips, tongue
• bone pain
• vaginal dryness
• vaginal bleeding (mainly in the first few weeks of treatment - if bleeding persists, consult your doctor)
• muscle pain

Uncommon (affects 1 to 10 people in 1000):

• changes in blood tests that show how the liver is working (liver function tests: gamma-glutamyltransferase [gamma-GT] and bilirubin levels in the blood);
• liver inflammation;
• hives;
• trigger finger (a condition where the finger or thumb clicks or locks when bent);
• high levels of calcium in the blood; if you experience nausea, vomiting, and increased thirst, consult your doctor or pharmacist, as you may need to have blood tests.

Rare (affects 1 to 10 people in 10,000):

• inflammatory skin conditions with red patches or blisters
• skin rashes caused by hypersensitivity (allergic reactions or anaphylactoid reactions)
• inflammation of small blood vessels, which may cause red or purple discoloration of the skin. Very rarely, this may be associated with joint pain, abdominal pain, and kidney pain, known as Henoch-Schönlein purpura.

Effects on bone

Arimidex lowers the levels of estrogen in the blood, which may cause a decrease in the mineral content of bones. This may lead to a decrease in bone density and an increased risk of bone fractures. Your doctor will take appropriate preventive and therapeutic measures to minimize these risks, in line with therapeutic guidelines for the prevention and treatment of bone problems in post-menopausal women. Discuss these risks and the possible treatments for bone problems with your doctor.

Reporting of side effects

If you experience 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 to the national reporting system (see below). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Arimidex

Store in a temperature not exceeding 30°C.

Keep the medicine out of the sight and reach of children. This medicine may harm them.

Do not use Arimidex after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

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 other information

What Arimidex contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients are lactose monohydrate, povidone, sodium carboxymethylcellulose, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

What Arimidex looks like and contents of the pack

White, round, biconvex film-coated tablets, approximately 6.1 mm in diameter, marked with A on one side and Adx1 on the other.

Available in packs of 28 tablets.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Arimidex: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

Date of last revision of the leaflet: 01/12/2022

For more information on this medicine, contact the national health authority or the manufacturer.