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PACKAGE LEAFLET: iNFORMATION FOR THE USER

Anastrozole 1 mg film-coated tablets

anastrozole

What is in this leaflet:

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

2.    What you need to know before you take Anastrozole 1 mg

3.    How to take Anastrozole 1 mg

4.    Possible side effects

5.    How to store Anastrozole 1 mg

6.    Contents of the pack and other information

Anastrozole 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 estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called 'aromatase'.

Do not take Anastrozole 1 mg

•    if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of this medicine (see section 6, What Anastrozole 1 mg contains).

•    if you are pregnant or breast-feeding (see the section called 'Pregnancy and breast-feeding').

Do not take Anastrozole 1 mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole 1 mg.

Warnings and precautions

Talk to your doctor or pharmacist before taking Anastrozole 1 mg.

Before treatment with Anastrozole 1 mg check with your doctor or pharmacist

•    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 estrogen (see the section called 'Other medicines and Anastrozole 1 mg').

•    if you 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 1 mg.

If you go into the hospital, let the medical staff know you are taking Anastrozole 1 mg.

other medicines and Anastrozole 1 mg

Please tell your doctor or pharmacist if you are taking or have recently taken 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 1 mg 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 1 mg from working properly.

•    Medicines that contain estrogen, 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 and breast-feeding

Do not take Anastrozole 1 mg if you are pregnant or breastfeeding. Stop Anastrozole 1 mg 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 this medicine. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole 1 mg contains lactose

Anastrozole 1 mg contains 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 medicine.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    The usual dose is one tablet once a day.

•    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 1 mg before, with or after food.

Keep taking Anastrozole 1 mg 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 1 mg should not be given to children and adolescents.

if you take more Anastrozole 1 mg than you should

If you take more Anastrozole than you should, talk to a doctor straight away.

if you forget to take anastrozole 1 mg

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 dose.

if you stop taking Anastrozole 1 mg

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

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

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

Very common side effects (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)

•    bone loss (osteoporosis) • feeling weak

Common side effects (affect 1 to 10 people in 100)

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 • 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 (affect 1 to 10 people in 1,000)

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 (affect 1 to 10 people in 10,000)

Rare inflammation of your skin that may include red patches or blisters • skin rash caused by hypersensitivity (this can be from 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 (affect less than 1 person 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 estrogen 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.

if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep this medicine out of the sight and reach of children. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is 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 that month.

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.

What Anastrozole 1 mg contains

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

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

The ingredients in the tablet coating are macrogol 400, hypromellose (E464), and titanium dioxide (E171).

What Anastrozole 1 mg looks like and contents of the pack

White film-coated round biconvex tablet, with the inscriptions

“ANA” and “1” on one side.

Anastrozole is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60,

84, 90, 98, 100 or 300 tablets and in hospital blisters of 28, 50, 84,

98, 300 or 500 tablets.

Not all pack sizes may be marketed.

marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:

Genthon BV Microweg 22 6545 CM Nijmegen The Netherlands

Manufacturers:

Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands

Synthon Hispania, S.L.

C/Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Barcelona

Spain

Distributed by:

Consilient Health (UK) Ltd.

500 Chiswick High Road,

London, W4 5RG United Kingdom

This leaflet was last approved in 07/2012

P0151