Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using ARIMIDEX?
ARIMIDEX contains the active ingredient anastrozole. ARIMIDEX is used to treat breast
cancer in women who no longer have their menstrual periods either naturally, due to
their age or after surgery, radiotherapy or chemotherapy.
2. What should I know before I use ARIMIDEX?
Do not use if you have ever had an allergic reaction to ARIMIDEX or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ARIMIDEX and affect how it works.
4. How do I use ARIMIDEX?
The usual dose is one tablet every day.
Swallow ARIMIDEX tablets whole, with a glass of water.
5. What should I know while using ARIMIDEX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ARIMIDEX.
Be sure to keep all your appointments with your doctor so your progress can be checked.
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Things you should not do
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Do not give ARIMIDEX to anyone else, even if they have the same condition as you.
Do not take ARIMIDEX to treat any other complaints unless your doctor tells you to.
Do not stop taking ARIMIDEX unless you have discussed it with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how ARIMIDEX affects you.
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Looking after your medicine
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Keep your tablets in the blister pack until it is time to take them.
Keep it in a cool, dry place where the temperature stays below 30°C.
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6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, some may
be minor and temporary. However, some side effects may be serious. Tell your doctor
immediately if you have sudden signs of allergy such as shortness of breath, wheezing
or difficulty in breathing, swelling of the face, lips, tongue or any other parts
of the body, rash, itching or hives on the skin, severe skin reactions with lesions,
ulcers or blisters, liver pain or swelling and/or a general feeling of unwell with
or without jaundice (yellowing of the skin and eyes).
Active ingredient: anastrozole
Consumer Medicine Information (CMI)
This leaflet provides important information about using ARIMIDEX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ARIMIDEX.
Where to find information in this leaflet:
1. Why am I using ARIMIDEX?
ARIMIDEX contains the active ingredient anastrozole. ARIMIDEX is a non-steroidal aromatase inhibitor, which reduces the amount of oestrogen
(female sex hormone) made by the body. In some types of breast cancer, oestrogen can
help the cancer cells grow. By blocking oestrogen, ARIMIDEX may slow or stop the growth
of cancer.
ARIMIDEX is used to treat breast cancer in women who no longer have their menstrual
periods either naturally, due to their age or after surgery, radiotherapy or chemotherapy.
Your doctor may have prescribed ARIMIDEX for another reason.
ARIMIDEX is not addictive.
2. What should I know before I use ARIMIDEX?
Warnings
Do not use ARIMIDEX if:
you are allergic to anastrozole, other anti-oestrogen medicines or any of the ingredients
listed at the end of this leaflet. Always check the ingredients to make sure you can
use this medicine.
you are still having menstrual periods
you are a man
ARIMIDEX should only be taken by women who are no longer having menstrual periods.
Men are not normally treated with ARIMIDEX.
Check with your doctor if you:
have any other medical conditions
have liver problems
have kidney problems
take any medicines for any other condition
have allergies to any medicines or any other substances, such as foods, preservatives
or dyes (symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty in breathing; swelling of the face, lips, tongue or any other parts
of the body; rash, itching or hives on the skin.)
have osteoporosis, a family history of osteoporosis or risk factors for developing
osteoporosis (such as smoking, a diet low in calcium, poor mobility, a slight build
or treatment with steroid medicines)
Aromatase inhibitors may decrease bone mineral density (BMD) in women who have been
through menopause, with a possible increased risk of fractures. Your doctor should
discuss with you your treatment options for managing this possible increased risk
of fractures. Aromatase inhibitors may cause inflammation in tendons (see Side effects).
At any sign of tendon pain or swelling - rest the painful area and contact your doctor.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take ARIMIDEX if you are pregnant or intend to become pregnant.
ARIMIDEX may affect your developing baby if you take it during pregnancy.
Do not breastfeed while taking ARIMIDEX.
Your baby can take in ARIMIDEX from breast milk if you are breastfeeding.
Children
Do not give ARIMIDEX to a child.
ARIMIDEX is not recommended for use in children.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines should not be taken with ARIMIDEX. These include:
tamoxifen, a medicine used to treat breast cancer
any medicine that contains oestrogen such as medicines used in Hormone Replacement
Therapy (HRT) or oral contraceptives
any health food products that contain natural estrogens used for post-menopausal symptoms
medicines from a class called "Luteinising Hormone Releasing (LHRH) agonists", such
as goserelin or leuprorelin
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ARIMIDEX.
4. How do I use ARIMIDEX?
How much to take
The usual dose is one tablet every day.
Swallow ARIMIDEX tablets whole, with a glass of water.
Follow the directions given to you by your doctor or pharmacist carefully, they may
differ from the information contained in the leaflet.
When to take ARIMIDEX
Take ARIMIDEX at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take ARIMIDEX before, with or after food.
How long to take ARIMIDEX
Continue taking ARIMIDEX for as long as your doctor or pharmacist tells you.
ARIMIDEX helps to control your condition, but does not cure it. Therefore you must
take ARIMIDEX every day. Do not stop taking it unless your doctor tells you to - even
if you feel better.
If you forget to take ARIMIDEX
ARIMIDEX should be used regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember, as long as it is 12 hours before
the next dose is due.
If it is less than 12 hours to the next dose, skip the dose you missed and take your
next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you use too much ARIMIDEX
If you think that you have used too much ARIMIDEX, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
5. What should I know while using ARIMIDEX?
Things you should do
Be sure to keep all your appointments with your doctor so your progress can be checked.
Tell any other doctors, dentists or pharmacists who are treating you that you are
taking ARIMIDEX.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking ARIMIDEX.
If you go into hospital, please let the medical staff know that you are taking ARIMIDEX.
Remind any doctor, dentist or pharmacist you visit that you are using ARIMIDEX.
Things you should not do
Do not give ARIMIDEX to anyone else, even if they have the same condition as you.
Do not take ARIMIDEX to treat any other complaints unless your doctor tells you to.
Do not stop taking ARIMIDEX unless you have discussed it with your doctor.
Do not take ARIMIDEX if the packaging is torn or shows signs of tampering.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ARIMIDEX
affects you.
Some patients may occasionally feel weak or sleepy.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take ARIMIDEX out of the blister pack it will not keep well.
Keep it in a cool, dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car on hot days or on a window sill.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
ARIMIDEX helps most postmenopausal women with breast cancer, but it may have unwanted
side effects in a few people.
If you get any side effects do not stop taking ARIMIDEX without first talking to your
doctor or pharmacist.
You may experience the following more common side effects of ARIMIDEX:
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Very common (may affect more than 1 in 10 people)
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What to do
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hot flushes
feeling weak or a lack of energy
joint pain or stiffness
bone loss (osteoporosis)
mild skin rash
feeling sick (nausea)
headache
feeling depressed
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Speak to your doctor if you have any of these very common side effects and they worry
you.
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Common (may affect up to 1 in 10 people)
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What to do
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feeling sleepy
vaginal dryness
vaginal bleeding
thinning of hair (hair loss)
diarrhoea
loss of appetite (anorexia)
vomiting
carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of hand)
pins and needles
loss of taste or changing taste of food or drink
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Speak to your doctor if you have any of these common side effects and they worry you.
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These side effects are mostly mild to moderate in nature.
Serious side effects
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Serious side effects
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What to do
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sudden signs of allergy such as shortness of breath, wheezing or difficulty in breathing;
swelling of the face, lips, tongue or any other parts of the body; rash, itching or
hives on the skin
severe skin reactions with lesions, ulcers or blisters
liver pain or swelling and/or a general feeling of unwell with or without jaundice
(yellowing of the skin and eyes)
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Serious side effects are uncommon or rare.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
ARIMIDEX may be associated with changes in your blood, urine or liver. Your doctor
may want to perform tests from time to time to check on your progress and detect any
unwanted side effects.
Uncommon side effects can include, trigger finger which is a condition in which one
of your fingers or your thumb catches in a bent position.
Cases of inflammation of a tendon or tendonitis (connective tissues that connect muscles
to bone) have been observed during the use of similar class of medicines, which might
also occur during treatment with ARIMIDEX.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ARIMIDEX contains
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Active ingredient
(main ingredient)
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anastrozole
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Other ingredients
(inactive ingredients)
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lactose monohydrate
povidone
sodium starch glycolate
magnesium stearate (E572)
hypromellose
macrogol 300
titanium dioxide (E171)
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Potential allergens
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lactose and titanium dioxide
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Do not take this medicine if you are allergic to any of these ingredients.
What ARIMIDEX looks like
ARIMIDEX 1 mg is a round, white, biconvex film-coated tablet with the following markings:
The are marked with a letter 'A' with an arrow head attached to the right leg of the
'A' on one side and marked Adx1 on the other (Aust R 54672).
ARIMIDEX comes in a blister pack containing 30 tablets.
Who distributes ARIMIDEX
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in September 2024.
ARIMIDEX® is a trade mark of the AstraZeneca group of companies
© AstraZeneca, 2024
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