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 taking AVODART?
AVODART contains the active ingredient dutasteride. AVODART is used in men who have
benign prostatic hyperplasia (BPH).
2. What should I know before I take AVODART?
Do not use if you have ever had an allergic reaction to AVODART, any other 5 alpha
reductase inhibitors or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines.
Talk to your doctor if your partner is pregnant or plans to become pregnant or is
breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with AVODART and affect how it works.
4. How do I take AVODART?
The usual dosage is one capsule once per day taken with or without food.
Swallow the capsule whole with some water.
5. What should I know while taking AVODART?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking AVODART.
If you are having a blood test remind your doctor that you are taking AVODART.
If you are having cataract surgery, tell your surgeon that you are taking AVODART.
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Things you should not do
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Do not stop using this medicine or change the dose.
Do not donate blood whilst taking AVODART or for 6 months after stopping treatment.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how AVODART
affects you.
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Looking after your medicine
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Store your capsules in the pack until it is time to take them.
Store the capsules below 30°C.
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6. Are there any side effects?
Side effects which have been reported include impotence (an inability to maintain
an erection), decrease in libido (sex drive), difficulty with ejaculation, decrease
in semen volume, dizziness when taken with an alpha blocker (e.g. tamsulosin), hair
loss (usually from the body) or hair growth, changes in your mood, feeling depressed,
breast swelling or tenderness and testicular pain or swelling.
Active ingredient(s):
dutasteride
Consumer Medicine Information (CMI)
This leaflet provides important information about using AVODART. 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 AVODART.
Where to find information in this leaflet:
1. Why am I taking AVODART?
AVODART contains the active ingredient dutasteride.
AVODART belongs to a group of medicines called 5 alpha reductase enzyme inhibitors.
AVODART is used in men who have benign prostatic hyperplasia (BPH).
BPH is a non-cancerous enlargement of the prostate gland which is located in the lower
portion of the urinary bladder surrounding the urethra (urine carrying tube). In men
with BPH, the prostate gland becomes large enough to squeeze the urine tube running
through it. If this tube is squeezed it narrows, making it more difficult to pass
urine and you may have some or all of the following symptoms:
difficulty in starting to urinate
an interrupted, weak urinary stream
more frequent urination, especially at night
feeling that you need to urinate right away
leaking or dribbling
a feeling that you cannot empty your bladder completely
As the disease progresses, untreated BPH can lead to an increased risk of complete
blockage of urine flow (acute urinary retention) and/or the need for surgery.
Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT).
AVODART lowers DHT production in the body leading to a shrinkage of the enlarged prostate
in most men.
Just as your prostate becomes enlarged over a long period of time, reducing the size
of your prostate and improving your symptoms may take time.
AVODART may also be taken in combination with another type of medicine known as an
alpha blocker (e.g. tamsulosin) in order to treat the symptoms of an enlarged prostate.
2. What should I know before I take AVODART?
Warnings
Do not use AVODART if:
you are allergic to dutasteride, 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 allergic to any other 5 alpha reductase enzyme inhibitors
you are a woman or child
you have severe liver disease
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
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
Talk to your doctor if your partner is pregnant or intends to become pregnant or is
breastfeeding.
Women (who are pregnant or may be pregnant) must avoid handling punctured or leaking
capsules. If skin contact occurs wash the affected area immediately with soap and
water.
If dutasteride is absorbed through the skin by a woman who is pregnant with a male
baby, it may cause the male baby to be born with abnormalities of the genital organs.
Dutasteride has been found in the semen of men taking AVODART. If your partner is
or may be pregnant you must avoid exposing her to your semen as dutasteride may affect
the normal development of a male baby.
You must use a condom during sex.
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.
Tell your doctor or pharmacist if you are allergic to any foods, dyes, preservatives
or any other medicines.
Some medicines may interfere with AVODART and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect AVODART.
4. How do I take AVODART?
How much to take
The usual dose is one capsule daily.
Follow the instructions provided and use AVODART until your doctor tells you to stop.
When to take AVODART
AVODART can be taken with or without food.
How to take AVODART
Swallow the capsule whole with some water.
Do not crush or chew the capsules. The contents of the capsule may make your mouth
or throat sore.
If you forget to take AVODART
AVODART should be used regularly at the same time each day.
If it is almost time for your 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 take too much AVODART
If you think that you have used too much AVODART, 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.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking AVODART?
Things you should do
Tell your doctor straight away if you:
have not taken AVODART exactly as directed
are having a blood test, tell your doctor you are taking AVODART as this medicine
decreases your prostate-specific antigen (PSA) levels.
The PSA test helps your doctor to tell if you have prostate disease, including prostate
cancer. If you have a higher than normal level of PSA in your blood it could mean
that you have a higher risk of prostate cancer. Men taking AVODART should have their
PSA measured 6 months after starting treatment and then regularly after that. You
could still be at risk for prostate cancer even though your PSA is lower. Your doctor
can still use PSA to help detect prostate cancer, by comparing your test results each
time you have a PSA test.
Remind any doctor, dentist or pharmacist you visit that you are using AVODART.
Things to be careful of
AVODART may also be taken in combination with another type of medicine called an alpha
blocker (e.g. tamsulosin) in order to treat symptoms of an enlarged prostate. If you
are having a cataract operation and are already taking or have previously taken an
alpha blocker medicine, the pupil may dilate poorly and the iris (the coloured part
of the eye) may become floppy during the operation (floppy iris syndrome). This can
be managed if your surgeon knows that you are taking or have taken an alpha blocker
before you have the operation. If you are going to have eye surgery tell your surgeon
that you are taking or have taken an alpha blocker.
In a clinical study of men at increased risk of developing prostate cancer, a serious
form of prostate cancer was reported more often in men taking AVODART than in men
who did not take AVODART. The reasons for this are currently unknown but may be due
to the design of the clinical study.
Things you should not do
Do not stop using this medicine suddenly or change the dose.
Some men notice an early improvement in their symptoms however others may need to
continue treatment for 3 to 6 months to see if AVODART works for them.
Continue to take this medicine as your symptoms improve.
If you do not take your medicine as directed it may interfere with your doctor’s ability
to monitor your PSA levels.
Do not donate blood whilst taking AVODART and for 6 months after you stop treatment.
Do not give this medicine to anyone else even if they have similar symptoms to you.
Do not use this medicine to treat any other complaints.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how AVODART
affects you.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place (below 30°C) away from moisture, heat or sunlight; for
example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep AVODART in its blister pack until it is time to take your dose.
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.
In clinical studies where patients were taking AVODART, the rate of heart failure
(meaning your heart does not pump blood as well as it should) was higher than in patients
taking AVODART and an alpha-blocker (e.g. tamsulosin) than in patients taking only
AVODART or only an alpha-blocker.
If you are taking AVODART and an alpha-blocker, talk to your doctor about this and
other possible side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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.
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 AVODART contains
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Active ingredient
(main ingredient)
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Dutasteride (500 micrograms dissolved in a liquid)
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Other ingredients
(inactive ingredients)
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butylated hydroxytoluene
mono- and di-glycerides
The capsule shell contains:
gelatin
glycerol
iron oxide yellow
lecithin
medium chain triglycerides
titanium dioxide
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Potential allergens
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lecithin
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Do not take this medicine if you are allergic to any of these ingredients.
What AVODART looks like
AVODART capsules are yellow, opaque and oblong soft gelatin capsules marked with GX
CE2.
AVODART is supplied in blister packs of either 10 (sample pack), 30 or 90 capsules.
Not all pack sizes may be distributed in Australia.
AUST R 90434
Who distributes AVODART
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford VIC 3067
Australia
Version 10.0
This leaflet was prepared on 2 May 2023.
Trade marks are owned by or licensed to the GSK group of companies.
©2023 GSK group of companies or its licensor.