AMENUR 1 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USERAMENUR 1 mg film-coated tabletsEFG

Anastrozole

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Amenur and what is it used for

Amenur 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 estrogens that are produced by your body. It does this by blocking a natural substance (an enzyme) in your body called 'aromatase'.

2. What you need to know before you take Amenur

Do not take Amenur

• If you are allergic (hypersensitive) 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 called “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.

Be careful with Amenur

Before taking Amenur, check with your doctor or pharmacist

• 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 Amenur”).
• 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 Amenur

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because anastrozole may affect the way other medicines work, and some medicines may have an effect on anastrozole.

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, certain 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.

Important information about some of the ingredients of Amenur

Amenur 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.

Amenur contains sodium

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

3. How to take Amenur

Follow exactly the instructions of your doctor and do not take more or less than prescribed. 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 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 Amenur than you should

If you take more anastrozole than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service on +34 91 562 04 20, stating the name and amount of the medicine taken.

If you forget to take Amenur

If you forget to take a dose, just take the next dose normally.

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

If you stop taking Amenur

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

If you have any other questions on the use of this medicine, 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 Amenur 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 that 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.
• Joint inflammation (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 in the blood called cholesterol, which would be seen in a blood test.
• Sleepiness.
• Carpal tunnel syndrome (tingling, pain, numbness or weakness in the hands).
• 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).
• Liver inflammation (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 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 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 red 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 eyes.
• A skin rash with small red or purple bumps and itching (lichenoid rash).
• Inflammation of a tendon or tendonitis (tissues that connect muscles to bones).
• Tendon rupture (tissues that connect muscles to bones).
• Memory loss.

Effects on your bones

Anastrozole lowers the levels of female sex hormones (estrogens) in your body. This may reduce the mineral content of your bones. This may make them weaker and increase the risk of fractures. Your doctor will monitor these risks according to the treatment guidelines for the bone condition in postmenopausal 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 Spanish Medicines and Health Products Agency (AEMPS) website at www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Amenur

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.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

No special storage conditions are required.

Store in the original package.

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 other information

What Amenur contains

The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.

The other ingredients (excipients) of the core are: lactose monohydrate (lactose), povidone (E1201), potato starch glycolate (potato starch), magnesium stearate (E572); the excipients of the coating are: hypromellose (E464), macrogol 6000, titanium dioxide (E171) and talc.

Appearance and packaging

White or almost white, round, biconvex film-coated tablet.

Amenur is available in blister packs, in packs containing 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

GP-Pharm, S.A.

Pol. Ind. Els Vinyets – Els Fogars C244, Km 22

08777 Sant Quintí de Mediona (Barcelona)

SPAIN

Manufacturer

Genepharm S.A.

18 Km Marathon Avenue

15351 Pallini

GREECE

Date of last revision of this leaflet: May 2025

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