Package Leaflet: Information for the User

Arimidex 1 mg Film-Coated Tablets

Anastrozole

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Arimidex contains a substance called anastrozol and belongs to a group of medications known as “aromatase inhibitors”. Arimidex is used to treat breast cancer in women who are in menopause.

Arimidex acts by reducing the amount of hormones called estrogens that are produced by your body, by blocking a natural bodily substance (an enzyme) called “aromatase”.

Do not take Arimidex

• if you are allergic to anastrozole or any of the other ingredients in this medication (listed in section 6).
• if you are pregnant or breastfeeding (see the section titled “Pregnancy and breastfeeding”).

Do not take Arimidex if you find yourself 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 reached menopause.
• if you are taking a medication that contains tamoxifen or medications that contain estrogen (see the section titled “Taking Arimidex with other medications”).
• if you have ever had any condition that affects the strength of your bones (osteoporosis).
• if you have any liver or kidney problems.

If you are unsure whether any of this affects you, consult your doctor or pharmacist before taking Arimidex.

Inform hospital staff that you are taking Arimidex if you are admitted to the hospital.

Taking Arimidex with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications you purchase without a prescription and herbal remedies. This is because Arimidex may affect the activity of other medications, and some medications may have an effect on Arimidex.

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

• Certain medications used to treat breast cancer (selective estrogen receptor modulators), such as medications that contain tamoxifen. This is because these medications may cause Arimidex to stop working properly.
• Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you find yourself in any of these situations, seek advice from your doctor or pharmacist.

Inform your doctor or pharmacist if you are taking the following:

• A medication known as an “LHRH analog”. This includes gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medications are used to treat breast cancer, certain gynecological health conditions, 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 medication.

Driving and operating machinery

It is unlikely that Arimidex will affect your ability to drive or use any tools or machinery. However, some patients may occasionally 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, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Arimidex contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one daily tablet.
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with the help of water.
• You can take Arimidex before, during, or after meals.

Continue taking Arimidex for the time your doctor or pharmacist tells you to. This is a long-term treatment and you may need to take it for several years. In case of doubt, consult your doctor or pharmacist.

Use in children and adolescents

Arimidex should not be administered to children and adolescents.

If you take more Arimidex than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Arimidex

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

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

If you interrupt treatment with Arimidex

Do not stop taking your tablets unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Stop taking Arimidex and seek urgent medical treatment if you experience any of the following severe but rare side effects:

• A severe skin reaction with blisters or ulcers on the skin, known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing, known as “angioedema”.

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

• Headache.
• Hot flashes.
• Dizziness (nausea).
• Skin 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

• Loss of appetite.
• Increased or high levels of a fatty compound in the blood known as cholesterol, which would be observed in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in areas of the hand).
• Itching, tingling, or numbness of the skin, loss / lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is functioning.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity) including face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually in the first weeks of treatment - if bleeding continues, talk to your doctor).
• Muscle pain.

Rare side effects may affect up to 1 in 100 people

• Changes in special blood tests that show how well your liver is functioning (gamma-GT and bilirubin).
• Liver inflammation (hepatitis).
• Hives or urticaria.
• Trigger finger (alteration in which one of the fingers of the hand stays bent).
• Increased amount of calcium in the blood. If you experience nausea, vomiting, and thirst, report to your doctor, pharmacist, or nurse as you may need a blood test.

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

• Rare skin inflammation that may include red patches or blisters.
• Skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).
• Inflammation of small blood vessels causing red or purple discoloration of the skin. Very rarely, symptoms of joint pain, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on your bones

Arimidex reduces the levels of hormones called estrogens present in your body. This can reduce the mineral content of your bones. They may be less strong and make fractures more likely. Your doctor will monitor these risks according to the treatment guidelines for bone health in postmenopausal women. You should talk to your doctor about the risks and treatment options.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, report to your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 86°F (30°C).

Keep this medication 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 medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Arimidex Composition

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

Appearance of the product and contents of the pack

White, round, biconvex film-coated tablets, approximately 6.1 mm in size, marked with a “A” on one face and 'Adx1' on the other.

Arimidex is presented in blister packs containing 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Juvisé Pharmaceuticals

149 boulevard Bataille de Stalingrad

69100 Villeurbanne

France

Responsible manufacturer

Haupt Pharma Muenster GmbH

Schleebrueggenkamp 15, Muenster

Nordrhein-Westfalen 48 159

Germany

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

This medicine is authorized in the member states of the European Economic Area with 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 comprimidos recubiertos con película

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

Slovakia: Arimidex

Romania: Arimidex

Sweden: Arimidex

Last review date of this leaflet:September 2021

Other sources of information

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