ANASTROZOLE 1MG FILM COATED TABLETS

Active substance: ANASTROZOLE

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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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Anastrozole 1 mg
Film-coated Tablets

Anastrozole 1 mg
Film-coated Tablets

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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
APSLA Limited, Bayview House, 49 North Strand Road, Dublin 3, Ireland.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th Floor, CP House, 97-107 Uxbridge Road,
Ealing,London W5 5TL
Distributed by:
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th Floor, CP House, 97-107 Uxbridge Road, Ealing,
London W5 5TL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Anastrozole 1 mg Film-coated Tablets
(Anastrozole)

This leaflet was last amended 08/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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