ANASTROZOL STADA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Anastrozole Stada contains a substance called anastrozole and 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 oestrogens that your body makes, by blocking a natural substance (an enzyme) called 'aromatase'.

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

Do not take Anastrozole Stada

• 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 the section on '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 starting Anastrozole Stada.

• 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 oestrogen (see the section on 'Other medicines and Anastrozole Stada').
• if you have ever had a condition that affects the strength of your bones (osteoporosis).
• if you have any liver or kidney problems.

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

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

Other medicines and Anastrozole Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because anastrozole can affect the way other medicines work, and some medicines can affect how anastrozole works.

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

• Certain medicines used to treat breast cancer (selective oestrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop anastrozole from working properly.
• Medicines that contain oestrogen, such as hormone replacement therapy (HRT).
• If you are in any of these situations, ask your doctor or pharmacist for advice.

Tell your doctor or pharmacistif you are taking any of the following:

• A medicine known as an 'LHRH analogue'. This includes goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, some gynaecological 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 this 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 Stada contains lactose

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

Anastrozole Stada contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially 'sodium-free'.

Use in athletes

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

3. How to take Anastrozole Stada

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist.

• The recommended dose is one tablet daily.
• 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 or pharmacist tells you to. This is a long-term treatment and you may need to take it for several years. If you are not sure, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole Stada than you should

If you take more anastrozole than you should, contact a doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the National Poison Information Service on 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Anastrozole Stada

If you forget to take a dose, just take the next dose at the 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 Anastrozole Stada

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, pharmacist, or nurse.

4. Possible side effects

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

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

• A very severe skin rash with ulcers or blisters in the skin. This is known as 'Stevens-Johnson syndrome'.
• Allergic reactions (hypersensitivity) with swelling of the throat, which may cause difficulty in swallowing or breathing. This is known as 'angioedema'.

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.
• High levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Feeling tired (fatigue).
• Carpal tunnel syndrome (tingling, pain, numbness, or weakness in the hand).
• Tingling, numbness, or prickling sensation of the skin, loss of taste.
• Diarrhoea.
• 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 nettle rash.
• Trigger finger (a condition in which one of your fingers gets stuck in a bent position).
• High levels of calcium in the blood. If you experience nausea, vomiting, and thirst, tell your doctor, pharmacist, or nurse, as you may need a blood test.

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

• A rare skin condition that may include redness 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 redness or purple spots on the skin. Very rarely, symptoms of joint pain, stomach pain, and kidney pain 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 are itchy)
• Tendon inflammation or tendonitis (tissues that connect muscles to bones)
• Tendon rupture (tissues that connect muscles to bones)
• Memory problems

Effects on your bones

Anastrozole reduces the levels of hormones called oestrogens in your body, which may reduce the mineral content of your bones. This may make them weaker and more likely to break. Your doctor will monitor these risks according to treatment guidelines for the management of bone conditions in post-menopausal women. You should talk to your doctor about the risks and treatment options.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

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 Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole Stada

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. Your tablets could harm them.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month stated.

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 Stada:

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients (excipients) are: in the tablet core lactose monohydrate (lactose), sodium carboxymethyl starch (type A) (potato), povidone (E1201), and magnesium stearate (E572).
• The coating ingredients are macrogol 400, hypromellose (E464), and titanium dioxide (E171).

Appearance and packaging

White, round, and biconvex film-coated tablet with the inscription "ANA" and "1" on one side.

Anastrozole Stada is available in blister packs, in packs containing 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Synthon Hispania, S.L.

Castelló, 1.

Polígono Las Salinas 08830

Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Date of last revision of this leaflet: June 2025

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