Main information

  • Trade name:
  • FINTAST finasteride 1 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • FINTAST finasteride 1 mg tablet blister pack
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210616
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


FINTAST finasteride 1 mg tablet blister pack

ARTG entry for

Medicine Registered


Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088


ARTG Start Date


Product category




Approval area

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

Product Type

Single Medicine Product

Effective date



See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Container information



Life Time




Blister Pack

PA/Al/PVC/Al -



uminium foil

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine


1. FINTAST finasteride 1 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration


Visual Identification

Brown colored, film coated, biconvex, octagonal shaped tablets, debossed

with 'J' on side and '81' on the other side

Active Ingredients


1 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 27.11.2017 at 09:15:52 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit for contact information

Patient Information leaflet


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

hair loss.

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

(androgenetic alopecia).

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

or face;

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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

taking FINTAST.

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

following happens:

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.

Product description

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.


Active ingredient

Finasteride 1 mg per tablet

Inactive ingredients


microcrystalline cellulose;

pregelatinised maize starch;

sodium starch glycollate type A;

docusate sodium;

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

South Melbourne

Victoria 3205


Distributed by Eris Pharmaceuticals (Australia) Pty Ltd

Toll free telephone (Australia): 1800 233 588

This leaflet was prepared in December 2015

Version 3.0


Danish Pharmacovigilance Update, 19 April 2012

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

Danish Medicines Agency

There are no news related to this product.