Anastrozole Sun 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozol SUN 1 mg film-coated tablets EFG

anastrozole

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 you should not give it 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 the leaflet:

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

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

Anastrozol SUN 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 are postmenopausal.

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

2. What you need to know before starting to take Anastrozol SUN

Do not take Anastrozol SUN:

??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 SUN:

??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 the section entitled “Taking Anastrozol SUN with other medicines”).

? if you have ever had a condition affecting the strength of your bones (osteoporosis).

??if you have any liver or kidney problems.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Anastrozol.

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

Taking Anastrozol SUN with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is because Anastrozol SUN may affect the action of other medicines, and some medicines may affect Anastrozol SUN.

Do not take Anastrozol SUN 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 tamoxifeno. 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.

Inform 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 health (gynaecological) disorders, and infertility.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Anastrozol SUN contains lactose

Anastrozol SUN contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Use in athletes

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

3. How to take Anastrozol SUN

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, 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 SUN before, during, or after meals.

Continue taking Anastrozol SUN for as long as your doctor or pharmacist has instructed you. 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 SUN than you should:

If you take more Anastrozol SUN than you should, contact a doctor immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, 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 SUN:

If you forget to take a dose, simply 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 missed dose.

If you stop taking Anastrozol SUN:

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

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 side effects:

• An extremely severe skin reaction with skin ulcers or blisters.

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
• Pain or stiffness in the joints
• 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 blood fat compound 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, numbness, or skin pins and needles, loss/lack of taste

• Diarrhea

• Vomiting

• Changes in blood tests showing 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 hand fingers remains bent)

• Increase in the amount of calcium in the blood. If you experience nausea, vomiting, or 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 discolouration. 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 red or purple itchy 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. As a result, bones may become weaker and fractures may become more likely. 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, talk to 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 Anastrozole SUN

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. These tablets could harm them.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol SUN

• The active substance is anastrozol. Each tablet contains 1 mg of anastrozol.
• The other components (excipients) are:

Tablet core:

Lactose monohydrate, maize starch, povidone, microcrystalline cellulose, sodium carboxymethyl starch from potato, colloidal anhydrous silica, magnesium stearate, talc.

Tablet coating:

Hypromellose, macrogol 400, titanium dioxide (E-171), talc.

Appearance of the medicinal product and contents of the pack

Anastrozol SUN 1 mg is presented as round, film-coated tablets, white in colour.

Each blister contains 10 or 14 tablets.

Pack sizes: 20, 28, 30, 60 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer

Remedica Ltd

Limassol Industrial Estate, Aharnon Street

P.O.Box 51706, 3508, Limassol

Cyprus

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

Date of the most recent revision of this leaflet: June 2025

Detailed 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/