Arimidex 1mg Film-Coated Tablet

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Arimidex 1 mg Film-coated Tablets

anastrozole

Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Arimidex is and what it is used for 2. Before you take Arimidex 3. How to take Arimidex 4. Possible side effects 5. How to store Arimidex 6. Further information What Arimidex is and what it is used for

Arimidex contains a medicine called anastrozole. This belongs to a group of medicines called 'aromatase inhibitors'. Arimidex is used to treat breast cancer in women who have gone through the menopause.

Arimidex 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'.

Before you take Arimidex Do not take Arimidex if: You are allergic (hypersensitive) to anastrozole or any of the other ingredients of Arimidex (see Section 6: Further information). You still have menstrual periods and have not yet gone through the menopause. You have moderate or severe liver problems. You have severe kidney problems. You are taking a medicine called tamoxifen or medicines that contain oestrogen. (See the section called 'Taking other medicines' overleaf.) You are pregnant or breast-feeding. (See the section called 'Pregnancy and breast-feeding' overleaf.)

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

Arimidex should not be given to children.

Take special care with Arimidex

Check with your doctor or pharmacist before taking Arimidex if:

You have ever had a condition that affects the strength of your bones (osteoporosis). You have problems with your liver or kidneys.

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

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Arimidex can affect the way some medicines work and some medicines can have an effect on Arimidex.

Do not take Arimidex if you are already taking any of the following medicines:

Tamoxifen. This is because tamoxifen may stop Arimidex 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 and breast-feeding

Do not take Arimidex if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines Arimidex 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 Arimidex. If this happens to you, ask your doctor or pharmacist for advice. Important information about some of the ingredients of Arimidex

Arimidex contains lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

How to take Arimidex

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

Arimidex should not be given to children.

Taking Arimidex 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 Arimidex before, with or after food.

Keep taking Arimidex 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.

If you take more Arimidex than you should

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

If you forget to take Arimidex 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 Arimidex

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

Possible side effects

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

Serious allergic reactions

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

Swelling of the face, lips, tongue or throat. This may cause difficulty in swallowing or breathing (rare, affects less than 1 in 1000 people). An extremely severe skin reaction with ulcers or blisters on the skin. This is known as 'Stevens-Johnson syndrome' (the frequency of this side effect is unknown).

Liver effects (uncommon, affect less than 1 in 100 people)

The signs may include:

Yellowing of your skin or eyes, dark coloured urine, a loss of appetite and a general feeling of being unwell.

If this happens to you, see a doctor straight away - you may need medical tests or treatment.

Other possible side effects (usually not severe):

Very common (affects more than 1 in 10 people)

Hot flushes. Feeling weak. Pain or stiffness in your joints. Skin rash (this can include a type of rash called 'hives' or 'nettle rash'). Feeling sick (nausea). Headache.

Common (affects less than 1 in 10 people)

Vaginal dryness. Bleeding from the vagina (usually in the first few weeks of treatment - if the bleeding continues, talk to your doctor). Thinning of your hair (hair loss). Diarrhoea. 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. Being sick (vomiting). Feeling sleepy. Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand). Changes in blood tests that show how well your liver is working.

Uncommon (affects less than 1 in 100 people)

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

Effects on your bones

Arimidex 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.

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.

How to store Arimidex Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them. Do not take your tablets after the expiry date which is stated on the container. The expiry date refers to the last day of that month. Keep your tablets below 30°C. Keep your tablets in the container they came in. 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 to protect the environment. Further information What Arimidex contains

The active substance is anastrozole. Each tablet contains 1 milligram (mg) of anastrozole.

The other ingredients are lactose monohydrate, macrogol, magnesium stearate, hypromellose, povidone, sodium starch glycolate and titanium dioxide.

What Arimidex looks like and contents of the pack

Arimidex comes as film-coated tablets. The tablets are white and round.

Arimidex comes in blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Arimidex 1 mg Film-coated Tablets is held by

AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU UK

Arimidex is manufactured by

AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Arimidex 1 mg Tablets

Reference number 17901/0002

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: March 2009

© AstraZeneca 2009

Arimidex is a trade mark of the AstraZeneca group of companies.

ONC 08 0049b

P026587

Arimidex 1mg Film Coated Tablet

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