Anastrozole Sandoz 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anastrozol Sandoz 1 mg film-coated tablets EFG

Read the entire 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, pharmacist or nurse.
• This medicine has been prescribed for you only and you must not pass it on to other people, even if they have the same symptoms as you. It could 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.

Contents of the leaflet

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

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

Anastrozol Sandoz contains a substance called anastrozole. It belongs to a group of medicines known as "aromatase inhibitors". Anastrozole is used to treat breast cancer in women who are postmenopausal.

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

2. What you need to know before taking Anastrozol Sandoz

Do not take Anastrozol Sandoz

• 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 section “Pregnancy and breastfeeding”).

Do not take anastrozole if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking anastrozole.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Anastrozol Sandoz:

• 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 section “Other medicines and Anastrozol Sandoz”),
• 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 the above apply to you, consult your doctor or pharmacist before taking Anastrozol Sandoz.

If you are admitted to hospital, inform healthcare professionals that you are taking anastrozole.

Other medicines and Anastrozol Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because anastrozole may affect the action of other medicines, and some medicines may have an effect on anastrozole.

Do not take anastrozole 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 tamoxifen. This is because these medicines may prevent anastrozole 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.

Consult 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 (gynaecological) health conditions, and infertility.

Pregnancy and breastfeeding

Do not take anastrozole if you are pregnant or breastfeeding. Stop taking anastrozole if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Anastrozol Sandoz contains sodium

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

Anastrozol Sandoz contains lactose, a type of sugar

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Use in athletes

This medicine contains anastrozole, which may produce a positive result in doping control tests.

3. How to take Anastrozol Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The usual 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 has instructed you. This is a long-term treatment and you may need to take it for several years.

Use in children and adolescents

Anastrozole must not be given to children and adolescents.

If you take more Anastrozol Sandoz than you should

If you have taken more anastrozole than you should, contact your 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 Anastrozol Sandoz

If you forget to take a dose, take the next dose at your usual time.

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

If you stop taking Anastrozol Sandoz

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

If you have any 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 will experience them.

Stop taking Anastrozol Sandoz and seek urgent medical attention if you experience any of the following very rare but serious adverse 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”.

Other possible adverse effects:

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, prickling or numbness of the skin, loss/absence of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests indicating how well your liver is functioning.
• Hair weakening (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 wheals.
• Trigger finger (a condition in which one of the fingers remains bent).
• Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, you should consult your doctor, pharmacist, or nurse, as you may need blood tests.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Rare skin inflammation which may include red spots or blisters.
• Skin rash caused by 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 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 itchy red or purple bumps on the skin).
• Inflammation of a tendon or tendinitis (connective tissues joining muscles to bones).
• Tendon rupture (connective tissues joining muscles to bones).
• Memory impairment.

Effects on your bones

Anastrozol reduces levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. They may become weaker and more prone to fractures. 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.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

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

5. Storage of Anastrozol Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack/bottle and outer carton following CAD/EXP. The expiry date refers to the last day of the month indicated.

Alu/PVC Blister

This medicine does not require any special storage conditions.

HDPE Bottles

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol Sandoz

The active substance is anastrozole.

Each film-coated tablet contains 1 mg of anastrozole.

The other components (excipients) are:

Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (potato type A), magnesium stearate, colloidal anhydrous silica, hydroxypropylcellulose.

Coating:

Opadry II White: monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171).

Appearance of the product and contents of the pack

White, round, biconvex film-coated tablets with the imprint “A1” on one side.

Film-coated tablets are available in Alu/PVC blisters or HDPE bottles with screw caps.

Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

HDPE bottle: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

United Kingdom: Anastrozole 1 mg film-coated tablet

Austria: Anastrozol Sandoz 1 mg – Filmtabletten

Belgium: Anastrozol Sandoz 1 mg filmomhulde tabletten

Denmark: Anastrozol Sandoz

Finland: Anastrozol Sandoz

France: Anastrozole Biostabilex 1 mg, comprimé pelliculé

Germany: Anastrozol SP 1 mg Filmtabletten

Hungary: Anastrozol Hexal filmtabletta

Italy: Anastrozolo Sandoz 1 mg compresse rivestite con film

Netherlands: Anastrozol Sandoz tablet 1 mg, filmomhulde tabletten

Norway: Anastrozol Sandoz

Poland: Anastrozol JACOBSEN

Romania: Anastraze 1 mg comprimate filmate

Slovenia: Anastrozol Sandoz 1 mg filmsko obložene tablete

Spain: Anastrozol Sandoz 1 mg comprimidos recubiertos con pelicula EFG

Sweden: Anastrozol Sandoz

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/