ANASTROZOL SANDOZ 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Anastrozole Sandoz 1 mg film-coated tablets EFG

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 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

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

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

Anastrozole Sandoz contains a substance called anastrozole. It belongs to a group of medicines called ‘aromatase inhibitors’. Anastrozole is used to treat breast cancer in women who are post-menopausal.

Anastrozole works by reducing the amount of hormones called estrogens that your body makes, by blocking a natural substance (an enzyme) called ‘aromatase’.

2. What you need to know before you take Anastrozole Sandoz

Do not take Anastrozole Sandoz

• 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”).

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start taking Anastrozole Sandoz.

• if you are still having menstrual periods and have not yet reached the menopause,

• if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called “Other medicines and Anastrozole Sandoz”),
• if you have ever had a condition that affects the strength of your bones (osteoporosis),
• if you have any problems with your liver or kidneys.

If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking Anastrozole Sandoz.

If you are going to have an operation, tell the doctor or nurse that you are taking anastrozole.

Other medicines and Anastrozole Sandoz

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is because anastrozole may affect the way other medicines work, and some medicines may affect the way anastrozole works.

Do not take anastrozole if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop anastrozole from working properly.
• Medicines that contain estrogen, such as hormone replacement therapy (HRT).

If you are in any of these situations, ask your doctor or pharmacist for advice.

Consult your doctor or pharmacist if you are taking any of 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, some gynecological conditions, and infertility.

Pregnancy and breast-feeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Anastrozole is unlikely to affect your ability to drive or use any tools or machines. However, occasionally some patients may feel weak or sleepy while taking anastrozole. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole Sandoz contains sodium

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

Anastrozole Sandoz contains lactose, which is a type of sugar

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Use in athletes

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

3. How to take Anastrozole Sandoz

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, consult your doctor or pharmacist.

• The usual dose is one tablet per day.
• Try to take your tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• You can take anastrozole before, during, or after food.

Keep taking anastrozole for as long as your doctor tells you to. This is a long-term treatment and you may need to take it for several years.

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole Sandoz than you should

If you have taken more anastrozole than you should, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Anastrozole Sandoz

If you miss a dose, take the next dose as usual.

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

If you stop taking Anastrozole Sandoz

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Anastrozole Sandoz and seek urgent medical attention, if you experience any of the following serious but very rare side effects:

• A very severe skin reactionwith 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 in swallowing or breathing. This is known as “angioedema”.

Other possible side effects:

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

• Headache.
• Hot flushes.
• Feeling sick (nausea).
• Rash.
• Pain or stiffness in the joints.
• Inflammation of the joints (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common side effects(may affect up to 1 in 10 people)

• Lack of appetite.
• Increased or high levels of a fatty substance in the blood called cholesterol, which would be seen in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, numbness, or weakness in the hand).
• Pins and needles, numbness, or tingling of the skin, loss of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is working.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity) including face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually in the first few weeks of treatment - if bleeding continues, talk to your doctor).
• Muscle pain.

Uncommon side effects(may affect up to 1 in 100 people)

• Changes in special blood tests that show how well your liver is working (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Hives or itching.
• Trigger finger (a condition where one of your fingers gets stuck in a bent position).
• High levels of calcium in the blood. If you get nausea, vomiting, and thirst, you should talk to your doctor, pharmacist, or nurse, you may need to have blood tests.

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

• A rare skin condition that may include red patches or blisters.
• A skin rash caused by an allergic reaction (this may be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels which may cause a red or purple rash on the skin. Very rarely, symptoms of joint pain, stomach pain, and kidney problems may occur; this is known as “Henoch-Schönlein purpura”.

Side effects with frequency not known (frequency cannot be estimated from the available data):

• Dry eye.
• Lichenoid rash (small, red or purple bumps on the skin that itch).
• Inflammation of a tendon or tendonitis (tissues that connect muscles to bones).
• Rupture of a tendon (tissues that connect muscles to bones).
• Memory loss.

Effects on your bones

Anastrozole reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones, making them weaker and more likely to break. Your doctor will monitor these risks according to treatment guidelines for the state of bones in post-menopausal women. You should discuss the risks and treatment options with your doctor.

Reporting of side effects

If you get 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 via the national reporting system: Spanish Medicines and Healthcare Products Agency (AEMPS) www.notificaram.es.

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

5. Storage of Anastrozole Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP. The expiry date is the last day of the month stated.

Alu/PVC Blister

This medicine does not require any special storage conditions.

HDPE Bottles

Do not store above 30°C

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 further information

What is in Anastrozole Sandoz

The active substanceis anastrozole.

Each film-coated tablet contains 1 mg of anastrozole.

The other ingredientsare:

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

Coating:

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

Appearance and packaging

White, round, and biconvex tablets with the inscription “A1” on one side.

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

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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

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 medicine is authorised in the Member States of the European Economic Area 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 película EFG

Sweden: Anastrozol Sandoz

Date of last revision of this leaflet: August 2025

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