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Anastrozole 1mg Film Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER Anastrozole 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Anastrozole is and what it is used for

2.    Before you take Anastrozole

3.    How to take Anastrozole

4.    Possible side effects

5.    How to store Anastrozole

6.    Further information

1.    WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR

The name of your medicine is Anastrozole 1 mg Film-coated Tablets. Anastrozole tablets are film-coated and contain the active ingredient anastrozole. The tablets are available in one strength. Each film-coated tablet contains 1 milligram of Anastrozole.

Anastrozole is one of a group of drugs called ‘aromatase inhibitors’. Anastrazole is used to treat breast cancer in women who have gone through the menopause. Anastrazole works by reducing 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.    BEFORE YOU TAKE ANASTROZOLE

Do not take Anastrozole if:

•    you are allergic (hypersensitive) to anastrozole or any of the other ingredients (see section 6: Further Information).

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

•    you are taking medicine called tamoxifen or medicines that contain oestrogen (see the section called ‘Taking Other Medicines’).

•    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

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

Anastrazole should not be given to children.

Take special care with Anastrozole

Before taking your medicine, tell your doctor 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 Anastrozole.

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

Taking other medicines

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

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

•    Tamoxifen (a particular medicine used to treat breast cancer), which may stop Anastrozole working properly

•    Medicines containing oestrogen for example 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 if you are pregnant or are breast feeding.

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

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.

Important information about some of the ingredients of Anastrozole

This medicinal product 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 medicinal product.

3.    HOW TO TAKE ANASTROZOLE

Always take Anastrozole exactly as your doctor has told you. Also read the label. You should check with your doctor or pharmacist if you are not sure.

Anastrozole should not be given to children.

Taking Anastrozole

•    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 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.

If you take more Anastrozole than you should

if you take more than your normal dose contact your doctor or the nearest hospital immediately. Take the carton containing any remaining tablets with you.

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If you forget to take Anastrozole

•    If you forget to take a dose, take your next dose as soon as you remember.

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

If you stop taking Anastrozole

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

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

4.    POSSIBLE SIDE EFFECTS

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

Serious allergic reactions

If you experience any of the following, call an ambulance or see a doctor immediately - 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 immediately - 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

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.

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.

5.    HOW TO STORE ANASTROZOLE

Keep out of the reach and sight of children.

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

Keep the tablets 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.    FURTHER INFORMATION

What Anastrozole contains

•    The active substance is Anastrozole.

•    The other ingredients of the tablet core are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate Type A, colloidal anhydrous silica, magnesium stearate, anhydrous lactose DT.

•    The film coat agent contains Opadry 04F58804 white, isopropyl alcohol and purified water.

•    Opadry 04F58804 white consists of Hypromellose 2910, Titanium dioxide (E171), and Macrogol/PEG 6000.

What Anastrozole looks like and contents of the pack

Anastrozole 1 mg Tablets are white, circular, biconvex film coated tablets with ‘A1’ on one side and plain on the other.

Anastrozole 1 mg Film-coated tablets are available in packs of 28 tablets.

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.

Manufacturer:

APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL

Marketed and Distributed By:

APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL

This leaflet was last amended 07/2012

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