Anastrozole Stada 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Anastrozol 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, 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Anastrozol Stada contains a substance called anastrozole and belongs to a group of medicines known as "aromatase inhibitors". Anastrozole is used to treat breast cancer in women who have gone through menopause.

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 starting to take Anastrozol Stada

Do not take Anastrozol Stada

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

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

Warnings and precautions

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

• you still have menstrual periods and have not yet reached menopause.
• you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section entitled “Other medicines and Anastrozol Stada”).
• you have ever had a condition affecting bone strength (osteoporosis).
• you have any liver or kidney problems.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking anastrozol.

If you are admitted to hospital, inform healthcare staff that you are taking anastrozol.

Other medicines and Anastrozol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you buy without a prescription and herbal medicines. This is because anastrozol may affect the action of other medicines, and some medicines may affect anastrozol.

Do not take anastrozol if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines containing tamoxifen. This is because these medicines may prevent anastrozol 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.

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

• A medicine known as an “LHRH analogue”, such as gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, certain female (gynaecological) health disorders, and infertility.

Pregnancy and breastfeeding

Do not take anastrozol if you are pregnant or breastfeeding. Stop treatment with anastrozol if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Anastrozol Stada contains lactose

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

Anastrozol Stada contains sodium

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

Use in athletes

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

3. How to take Anastrozol Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

• The recommended 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 anastrozol before, during, or after meals.

Continue taking anastrozol for as long as your doctor or pharmacist has instructed. This is a long-term treatment and you may need to take it for several years. If in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozol must not be given to children and adolescents.

If you take more Anastrozol Stada than you should

If you take more anastrozol than you should, contact a doctor immediately. In case of overdose or accidental ingestion, consult 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 Stada

If you forget to take a dose, simply take the next dose as scheduled. Do not take a double dose (two doses at the same time) to make up for forgotten doses.

If you stop taking Anastrozol Stada

Do not stop taking your tablets unless instructed by your doctor.

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

4. Possible adverse effects

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

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

• A very 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 that may cause difficulty swallowing or breathing. This is known as “angioedema”.

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

• Headache.
• Hot flushes.
• Dizziness (nausea).
• Skin rash.
• Joint pain or stiffness.
• Inflammation of the joints (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 or lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests indicating how well your liver is functioning.
• Hair thinning (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 welts.
• Trigger finger (a condition in which one of the fingers of the hand remains bent).
• Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, inform your doctor, pharmacist, or nurse, as you may need a blood test.

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

• Rare skin inflammation that 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 of joint, stomach, and 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

Anastrozole reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. Bones may become weaker, increasing the likelihood of 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of Anastrozol 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. The tablets could harm them.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol Stada:

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

Appearance of the product and contents of the pack

White, round, biconvex film-coated tablet, with the inscriptions “ANA” and “1” on one side.

Anastrozol Stada is available in blisters, in packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

The Netherlands

Date of the most recent review of this leaflet: June 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/