Avodart

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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).
For more information, see Section 1. Why am I taking AVODART? in the full CMI.

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.
For more information, see Section 2. What should I know before I take AVODART? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AVODART and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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.
More instructions can be found in Section 4. How do I take AVODART? in the full CMI.

5. What should I know while taking AVODART?

Things you should do
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.
Things you should not do
Do not stop using this medicine or change the dose.
Do not donate blood whilst taking AVODART or for 6 months after stopping treatment.
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
Store your capsules in the pack until it is time to take them.
Store the capsules below 30°C.
For more information, see Section 5. What should I know while taking AVODART? in the full CMI.

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.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
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

Less serious side effects
What to do
impotence (inability to maintain an erection)
decrease in libido (sex drive)
difficulty with ejaculation
decrease in sperm count and 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
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
allergic reaction – signs include wheezing, difficulty breathing, swelling of the lips or mouth, a rash or hives on the skin and fainting
breast swelling or tenderness. If this becomes troublesome or you notice breast lumps or nipple discharge talk to your doctor about these changes as they could be signs of a serious condition such as breast cancer
testicular pain and/or swelling
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.
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

Active ingredient
(main ingredient)
Dutasteride (500 micrograms dissolved in a liquid)
Other ingredients
(inactive ingredients)
butylated hydroxytoluene
mono- and di-glycerides
The capsule shell contains:
gelatin
glycerol
iron oxide yellow
lecithin
medium chain triglycerides
titanium dioxide
Potential allergens
lecithin
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.