Summary for ARTG Entry:
FINTAST finasteride 1 mg tablet blister pack
ARTG entry for
Aurobindo Pharma Australia Pty Ltd
5 / 148 Spit Road,Mosman, NSW, 2088
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. FINTAST finasteride 1 mg tablet blister pack
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
FINTAST is indicated for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss in men 18
years or older. Efficacy has not been demonstrated in men over the age of 41 years. FINTAST is not indicated for use in women (see Use in Pregnancy
and Clinical Studies) or children.
Additional Product information
Store below 25
Pack Size/Poison information
(S4) Prescription Only Medicine
(S4) Prescription Only Medicine
1. FINTAST finasteride 1 mg tablet blister pack
Tablet, film coated
Route of Administration
Brown colored, film coated, biconvex, octagonal shaped tablets, debossed
with 'J' on side and '81' on the other side
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Consumer Medicine Information
Finasteride 1 mg film-coated tablets
What is in this leaflet
This leaflet answers some common questions about FINTAST. It does not contain all the available
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking FINTAST
against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What FINTAST is used for
FINTAST is for use by men only.
FINTAST, in the 1 mg strength, is used to treat men with male pattern hair loss to increase hair
growth on the scalp and to prevent further hair loss.
Male pattern hair loss (also known as androgenetic alopecia) is a common condition in which men
experience thinning of the hair on the scalp. This often results in a receding hair line and/or balding
on the top of the head. These changes typically start to occur in some men in their 20s and
become more common with age. Once hair loss has occurred over a long period of time, the hair
may be permanently lost.
Male pattern hair loss is thought to be caused by a combination of family history (heredity) and
production of a particular male hormone, called dihydrotestosterone (DHT). Men with male pattern
hair loss have more DHT in the balding part of their scalp than in other parts, resulting in increased
How FINTAST works
FINTAST, in the 1 mg strength, specifically lowers the levels of DHT in the scalp, thus helping to
reverse the balding process.
FINTAST does not affect hair on other parts of the body.
Men with mild to moderate, but not complete, hair loss can expect to benefit from the use of
FINTAST. In women who were studied, FINTAST was not effective in the treatment of hair loss
There should be no need to change your usual hair care routine (for example, shampooing or
haircuts) because you are taking FINTAST.
FINTAST is not addictive.
Before you take it
When you must not take it
Do not take FINTAST if:
you have an allergy to FINTAST or any of the ingredients listed at the end of this
Symptoms of an allergic reaction to FINTAST may include skin rash, or swelling of the lips
the packaging is torn or shows signs of tampering; or
the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking FINTAST, talk to your doctor.
Women who are pregnant or may be pregnant must not take FINTAST, handle crushed or
broken tablets or handle tablets with wet hands.
If the active ingredient in FINTAST is absorbed after swallowing the tablet or 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 sex organs.
Whole tablets are coated to prevent contact with the active ingredient during normal handling,
provided that the tablets haven't been crushed or broken.
If a pregnant woman swallows FINTAST, handles crushed or broken tablets or handles
tablets with wet hands, her doctor must be consulted immediately.
Do not give FINTAST to children or women.
Before you start taking it
Tell your doctor if:
you have or have had any medical conditions; or
you have any allergies to any other medicines or any other substances, such as
foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you take any
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may affect the way other medicines work. However, FINTAST has not been
shown to interfere with other medicines.
Driving and operating machinery
FINTAST should not affect your ability to drive or operate machinery.
How to take it
How much to take
Take FINTAST only when prescribed by your doctor.
The dose is one tablet taken once each day. FINTAST will not work faster or better if you take it
more than once a day.
Swallow FINTAST with a glass of water.
It does not matter if you take FINTAST before or after food.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose
when you are meant to.
If it is not nearly time for your next dose, take it as soon as you remember, and then go
back to taking your tablet as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
How long to take it
Male pattern hair loss is a condition that develops over a long period of time. Because it takes time
for new hair to grow, you will not see immediate results. In general, daily use for 3 months or more
may be necessary before you notice increased hair growth or prevention of further loss. Continue
taking FINTAST for as long as your doctor prescribes.
If you stop taking it
If you stop taking the tablets your hair loss is likely to resume.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for
advice, if you think that you or anyone else may have taken too much FINTAST. Do this
even if there are no signs of discomfort or poisoning.
While you are taking it
Things you must do
If you are about to be started on any new medicine tell your doctor and pharmacist that you
are taking FINTAST.
Things you must not do
Do not give FINTAST to anyone else, even if they have the same condition as you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are
FINTAST helps most men with male pattern hair loss, but it may have unwanted side effects in a
few men. All medicines can have side effects. Sometimes they are serious, most of the time they
are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
difficulty in achieving an erection that continues after stopping FINTAST;
less desire for sex that continued after stopping FINTAST; or
decreased amount of semen released during sex (this decrease does not appear to
interfere with normal sexual function).
It is important to understand that, in clinical trials, these unwanted effects disappeared in men who
stopped taking FINTAST, as well as in many men who continued treatment.
Problems with ejaculation that continue after stopping medication have been reported
infrequently. Tell your doctor if you notice this and it worries you.
Male infertility and/or poor quality of semen have been reported infrequently. Improvement in the
quality of semen has been reported after stopping FINTAST.
Tell your doctor immediately if you notice any of the following:
breast swelling and/or tenderness. In rare cases, male breast cancer has been reported;
breast lumps, pain or discharge from the nipples;
skin rash, itchiness;
hives or nettlerash (pinkish, itchy swellings on the skin);
testicle pain; or
depressions (feelings of severe sadness and unworthiness).
These are uncommon side effects that have been reported with FINTAST.
Tell your doctor immediately or go to accident and emergency at your nearest hospital if the
swelling of the lips, tongue, throat or face.
These may be symptoms of a serious allergic reaction to FINTAST, which may cause difficulty in
swallowing or breathing. You may need urgent medical attention. Serious side effects are rare.
Other side effects not listed above may occur in some men. Tell your doctor or pharmacist
if you notice any other unwanted effects.
After taking it
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Never put the tablets in another box or container, as they might get mixed up.
Keep FINTAST in a cool dry place where the temperature stays below 25°C. Do not store it
or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store
If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry
date, ask your pharmacist what to do with any that are left over.
What it looks like
FINTAST (1 mg finasteride tablets) are supplied in pack sizes* of 28 or 30 tablets in blister packs.
FINTAST 1 mg finasteride tablets (AUST R: 210616)
Brown coloured, film coated, biconvex, octagonal shaped tablets, debossed with ‘J’ on side and
‘81’ on the other side.
Finasteride 1 mg per tablet
pregelatinised maize starch;
sodium starch glycollate type A;
magnesium stearate; and
Opadry complete film coating system 20A565004 Brown.
*Some of these pack sizes are not marketed.
Sponsor/Marketing Authorisation Holder
Aurobindo Pharma Australia Pty Ltd
6 Eastern Road
Distributed by Eris Pharmaceuticals (Australia) Pty Ltd
Toll free telephone (Australia): 1800 233 588
This leaflet was prepared in December 2015