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ARIMIDEX 1MG TABLETS

Active substance: ANASTROZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®
ARIMIDEX 1mg TABLETS / ANASTROZOLE 1mg TABLETS
(anastrozole)
This product is available as any of the above but will be referred to as Arimidex throughout the
remainder of this leaflet.
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 or nurse.
• 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 or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Arimidex is and what it is used for
2. What you need to know before you take Arimidex
3. How to take Arimidex
4. Possible side effects
5. How to store Arimidex
6. Contents of the pack and other information
1. WHAT ARIMIDEX IS AND WHAT IT IS USED FOR
Arimidex contains a substance 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 estrogen 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 ARIMIDEX
Do not take Arimidex
• 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 the section called ‘Pregnancy and breast-feeding’).
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.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before taking Arimidex:
• 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 Arimidex’).
• 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
Arimidex.
If you go into the hospital, let the medical staff know you are taking Arimidex.
Other medicines and Arimidex
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:
• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g.
medicines that contain tamoxifen. This is because these medicines may stop Arimidex 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 Arimidex if you are pregnant or breast-feeding. Stop Arimidex if you become pregnant and
talk to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Arimidex contains lactose
Arimidex 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.
3. HOW TO TAKE ARIMIDEX
Always take Arimidex exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
• The recommended 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 or pharmacist tells you to. It is a long-term treatment
and you may need to take it for several years. Check with your doctor or pharmacist if you are not
sure.
Use in children and adolescents
Arimidex should not be given to children and adolescents.
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
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).
• Feeling weak.
• Bone loss (osteoporosis).
Common side effects (affect 1 to 10 people in 100)
• Loss of appetite.
• Raised or high levels of 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).
• Tickling, tingling or numbness of skin, loss/lack of taste.
• 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).
• Muscle pain.
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).
• Increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, you
should tell your doctor, or pharmacist or nurse as you may need to have blood tests.
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-Schönlein
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 ‘StevensJohnson 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
Arimidex 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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.
5. HOW TO STORE ARIMIDEX
• Arimidex should not be stored above 30°C.
• Keep out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of
your pharmacist who will advise you what to do.
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
Your medicine is called Arimidex. Each tablet contains 1mg of the active ingredient anastrozole, in a
white, round tablet coded 'ADX 1' on one side and 'A↓' on the other.
Arimidex also contain the following: lactose, macrogol 300, magnesium stearate, methylhydroxypropyl
cellulose, polyvidone, sodium starch glycollate and titanium dioxide (E171).
Arimidex are available as blister packs of 28 tablets.
PL No: 15814/0550

Arimidex 1mg Tablets / Anastrozole 1mg Tablets

POM

This product is manufactured by AstraZeneca UK Ltd, Macclesfield, Cheshire and is procured from
within the EU and repackaged by the Product Licence holder who is: O.P.D. Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 24.03.2014.
Arimidex® is a registered trade mark of the AstraZeneca group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER
®
ARIMIDEX 1mg TABLETS / ANASTROZOLE 1mg TABLETS
(anastrozole)
This product is available as any of the above but will be referred to as Arimidex throughout the
remainder of this leaflet.
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 or nurse.
• 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 or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Arimidex is and what it is used for
2. What you need to know before you take Arimidex
3. How to take Arimidex
4. Possible side effects
5. How to store Arimidex
6. Contents of the pack and other information
1. WHAT ARIMIDEX IS AND WHAT IT IS USED FOR
Arimidex contains a substance 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 estrogen 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 ARIMIDEX
Do not take Arimidex
• 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 the section called ‘Pregnancy and breast-feeding’).
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.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before taking Arimidex:
• 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 Arimidex’).
• 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
Arimidex.
If you go into the hospital, let the medical staff know you are taking Arimidex.
Other medicines and Arimidex
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:
• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g.
medicines that contain tamoxifen. This is because these medicines may stop Arimidex 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 Arimidex if you are pregnant or breast-feeding. Stop Arimidex if you become pregnant and
talk to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Arimidex contains lactose
Arimidex 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.
3. HOW TO TAKE ARIMIDEX
Always take Arimidex exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
• The recommended 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 or pharmacist tells you to. It is a long-term treatment
and you may need to take it for several years. Check with your doctor or pharmacist if you are not
sure.
Use in children and adolescents
Arimidex should not be given to children and adolescents.
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
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).
• Feeling weak.
• Bone loss (osteoporosis).
Common side effects (affect 1 to 10 people in 100)
• Loss of appetite.
• Raised or high levels of 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).
• Tickling, tingling or numbness of skin, loss/lack of taste.
• 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).
• Muscle pain.
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).
• Increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, you
should tell your doctor, or pharmacist or nurse as you may need to have blood tests.
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-Schönlein
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 ‘StevensJohnson 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
Arimidex 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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.
5. HOW TO STORE ARIMIDEX
• Arimidex should not be stored above 30°C.
• Keep out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of
your pharmacist who will advise you what to do.
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. FURTHER INFORMATION
Your medicine is called Arimidex. Each tablet contains 1mg of the active ingredient anastrozole, in a
white, round tablet coded 'ADX 1' on one side and 'A↓' on the other.
Arimidex also contain the following: lactose, macrogol 300, magnesium stearate, methylhydroxypropyl
cellulose, polyvidone, sodium starch glycollate and titanium dioxide (E171).
Arimidex are available as blister packs of 28 tablets.
PL No: 15814/0550

Arimidex 1mg Tablets / Anastrozole 1mg Tablets

POM

This product is manufactured by AstraZeneca Ltd, Macclesfield, Cheshire and is procured from within
the EU and repackaged by the Product Licence holder who is: O.P.D. Laboratories Ltd, Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 24.03.2014.
Arimidex® is a registered trade mark of the AstraZeneca group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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