Consumer Medicine Information
Finasteride 5 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 5 mg strength, is used to treat a medical condition in men called benign prostatic
hyperplasia or BPH. BPH is a condition where your prostate gland (which is near your bladder) has
become bigger making it more difficult for you to pass urine. This can lead to symptoms such as:
weak or interrupted stream of urine;
feeling that you cannot empty your bladder completely;
delay before you start to pass urine;
needing to pass urine often, especially at night; or
feeling that you must pass urine right away.
BPH occurs only in men and is common over the age of 50 years. In some men, BPH can lead to
serious problems, including urinary tract infections and the sudden inability to pass urine at all.
BPH can also lead to the need for surgery such as procedures to improve the flow of urine.
The prostate gland takes years to grow. Therefore, the symptoms of BPH take a long time to
How FINTAST works
FINTAST, in the 5 mg strength, works by slowly reducing the size of your prostate gland. This may
lead to gradual improvement in your urine flow and other symptoms over several months.
FINTAST also helps reduce the risk of developing a sudden inability to pass urine (acute urinary
retention) and the need for surgery. This may happen whether or not you notice any improvement
or change in your symptoms.
Your doctor may have prescribed FINTAST for another reason. Ask your doctor if you have any
questions about why FINTAST has been prescribed for you.
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
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. FINTAST tablets are coated and will prevent contact with the
active ingredient during normal handling, provided that the tablets are not broken or crushed.
If a pregnant woman swallows FINTAST, handles crushed or broken tablets, 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 usual dose in men is one tablet taken once each day.
Swallow FINTAST with a glass of water.
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
When to take it
Take FINTAST once a day at about the same time each day.
This will help you to remember to take the tablets.
It does not matter if you take FINTAST before or after food.
How long to take it
FINTAST shrinks the prostate gland slowly. Therefore, you may need to take FINTAST for 6
months or longer to see whether it helps you. If it does help your symptoms, you may need to take
FINTAST every day. Continue taking FINTAST for as long as your doctor prescribes. If you stop
taking the medicine the prostate gland is likely to grow again.
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. Otherwise, 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.
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
Go to your doctor for regular check-ups, including a physical check for prostate cancer
once a year if you are over 50.
While BPH is not cancer and does not lead to cancer, the two conditions can exist at the same
FINTAST is used for BPH not prostate cancer.
If you are having a blood test to measure your PSA (prostate-specific antigen) levels, tell
your doctor 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 BPH, but it may have unwanted side effects in a few people. 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:
impotence (inability to have an erection) that continues after stopping FINTAST;
less desire for sex that continued after stopping FINTAST; or
problems with ejaculation that continued after stopping the medication.
Changes or problems with ejaculation, such as decreased amount of semen released
during sex (this decrease does not appear to interfere with normal sexual function).
Male infertility and/or poor quality of semen have been reported infrequently. Improvement in the
quality of semen has been reported after stopping FINTAST.
These are the more common side effects of FINTAST. For the most part these have been mild. In
some cases, these side effects disappeared while the patient continued to take FINTAST. If
symptoms persisted, they usually resolved on stopping the tablets.
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 patients. Tell your doctor if you
notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
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 (5 mg finasteride tablets) are supplied in pack sizes* of 28 or 30 tablets in blister packs.
FINTAST 5 mg finasteride tablets (AUST R: 210614)
Blue coloured, circular, biconvex, bevel edged film-coated tablets debossed with ‘E’ on side and
‘61’ on the other side.
Finasteride 5 mg per tablet
pregelatinised maize starch;
sodium starch glycollate type A;
magnesium stearate; and
Opadry complete film coating system 20A50535 Blue contains.
*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