PACKAGE LEAFLET: INFORMATION FOR THE USER

ANASTROZOLE 1 MG FILM-COATED TABLETS

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.

What is in this leaflet:

1.    What anastrozole is and what it is used for

2.    What you need to know before you take anastrozole

3.    How to take anastrozole

4.    Possible side effects

5.    How to store anastrozole

6.    Contents of the pack and other information

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1. WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR

The name of this medicine is Anastrozole 1mg film-coated tablets (called anastrozole in this leaflet).

It belongs to a group of medicines called ‘aromatase inhibitors’. Anastrozole is used to treat breast cancer in women who have gone through the menopause.

Anastrozole works by cutting down the amount of the hormone called oestrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase’.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANASTROZOLE

Do not take anastrozole

*    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, breast-feeding and fertility)

Do not take anastrozole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking anastrozole.

Warnings and precautions

Talk to your doctor or pharmacist before taking anastrozole:

*    if you still have menstrual periods and have not yet gone through the menopause

*    If you are taking a medicine that contains tamoxifen or medicines that contain oestrogen (see the section ‘Other medicines and anastrozole’)

*    if you have ever had a condition that affects the strength of your bones (osteoporosis)

*    if you have problems with your liver or kidneys

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking anastrozole.

If you go into the hospital, let the medical staff know you are taking anastrozole.

Other medicines and anastrozole

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes medicines that you buy without a prescription and herbal medicines. This is because anastrozole can affect the way some medicines work and some medicines can 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 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 this applies to you, ask your doctor or pharmacist for advice.

Tell 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) conditions, and infertility.

Pregnancy, breast-feeding and fertility

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Anastrozole is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel weak or sleepy while taking anastrozole. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole 1mg film-coated tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE ANASTROZOLE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet once daily

Try to take your tablet at the same time each day.

Swallow the tablet whole with a drink of water.

It does not matter if you take anastrozole before, with or after food.

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

Use in children

Anastrozole should not be given to children and adolescents.

If you take more anastrozole than you should

If you take more anastrozole than you should, talk to your doctor straight away.

If you forget to take anastrozole

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

If you stop taking anastrozole

Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.

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

Brand: ANASTROZOLE LEAFLET 1MG FILM COATED TABLETS 28S UK

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4. POSSIBLE SIDE EFFECTS

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

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

*    Headache

*    Hot flushes

*    Feeling sick (nausea)

*    Skin rash

*    Pain or stiffness in your joints

*    Inflammation of the joints (arthritis)

*    Feeling weak

*    Bone loss (osteoporosis)

Common (may affect up to 1 in 10 people)

*    Loss of appetite

*    Raised or high levels of a fatty substance known as cholesterol in your blood. This would be seen in a blood test

*    Feeling sleepy

*    Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)

*    Diarrhoea

*    Being sick (vomiting)

*    Changes in blood tests that show how well your liver is working

*    Thinning of your hair (hair loss)

*    Allergic (hypersensitivity) reactions including face, lips, or tongue

*    Bone pain

*    Muscle pain

*    Vaginal dryness

*    Bleeding from the vagina (usually in the first few weeks of treatment - if the bleeding continues, talk to your doctor)

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

*    High calcium levels in your blood (hypercalcaemia)

*    Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin)

*    Inflammation of the liver (hepatitis)

*    Hives or nettle rash

*    Trigger finger (a condition in which your finger or thumb catches in a bent position)

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

*    Rare inflammation of your skin that may include red patches or blisters

*    Skin rash caused by hypersensitivity (this can be from an allergic or anaphylactoid reaction)

*    Inflammation of the small blood vessels causing red or purple colouring of the skin. Very rarely symptoms of joint, stomach, and kidney pain may occur; this is known as ‘Henoch-Schonlein purpura’

Very rare side effects (may affect up to 1 in 10,000 people)

*    An extremely severe skin reaction with ulcers or blisters on the skin. This is known as ‘Stevens-Johnson syndrome’

*    Allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing. This is known as ‘angioedema’

If any of these happen to you, call an ambulance or see a doctor straight away - you may need urgent medical treatment.

Effects on your bones

Anastrozole lowers the amount of the hormone called oestrogen that is in your body. This may lower the mineral content of your bones. Your bones may be less strong and may be more likely to fracture. Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause. You should talk to your doctor about the risks and treatment options.

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

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Brand: ANASTROZOLE LEAFLET 1MG FILM COATED TABLETS 28S UK

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5. HOW TO STORE ANASTROZOLE

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 label 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 that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Anastrozole 1 mg film-coated tablets contain

*    The active substance is anastrozole. One tablet contains 1 mg of anastrozole.

*    The other ingredients in the tablet core are lactose monohydrate, sodium starch glycolate, povidone (E1201), and magnesium stearate (E572).

*    The ingredients in the tablet coating are macrogol, hypromellose (E464), and titanium dioxide (E171).

What Anastrozole 1 mg film-coated tablets look like and contents of the pack

Anastrozole is a white film-coated round tablet, with the inscriptions “ANA” and “1” on one side.

Anastrozole is available in blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer: Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands

or Synthon Hispania, S.L. C/Castello, 1 Polfgono Las Salinas, 08830 Sant Boi de Llobregat, Barcelona, Spain This leaflet was last revised in September 2013.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist

‘Zentiva’ is a registered trade mark. © 2013 Zentiva.

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Artwork Approval

Reason for Circulation:

Zentiva Regulatory Approved: YesO NoO N/AO Date:    THESE

Signature:

Zentiva - Head of Regulatory

Approved: YesO No N/AO

Date:FOR ZENTIvA

Signature:

Other - as required

Approved: YesO NoO Date:

Signature:

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