FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack

Main information

  • Trade name:
  • FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 189272
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189272

FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

17/10/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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.

Products

1. FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

25/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

FINASTERIDE AN 1 mg 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. FINASTERIDE AN 1 mg is not indicated for use in

women (see Use in Pregnancy and Clinical Studies) or children.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

4 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Reddish brown, 7 mm, round, biconvex, film-coated tablet, marked 'F1' on

one side and plain on the other.

Active Ingredients

Finasteride

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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:28:31 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 www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Finasteride AN 1mg tablets – Consumer Medicine Information

Finasteride AN CMI v2.0

Page 1

Finasteride AN tablets

Finasteride AN tablets 1 mg

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Finasteride AN 1 mg tablets.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed

risks

taking

Finasteride

against

benefits they expect it will have

for you.

If

you

have

any

concerns

about

taking

this

medicine,

talk

to

your

doctor

or

pharmacist.

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What Finasteride AN

1 mg tablets are used

for

Finasteride AN 1 mg tablets are

for use by men only.

It is used to treat men with male

pattern hair loss to increase hair

growth

scalp

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 20’s and become

more common with age.

Once

hair

loss

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 (hereditary) 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 Finasteride AN

works

Finasteride AN 1 m g t a b l e t s

specifically

lowers the levels of

DHT in the scalp, thus helping

to reverse the balding process.

It does not affect hair on other

parts of the body.

Men with mild to moderate, but

complete,

hair

loss

expect to benefit from the use

of this medicine.

women

were

studied,

Finasteride

effective in the treatment of hair

loss (androgenetic alopecia).

There

should

need

change

your

usual

hair

care

routine

(for

example,

shampooing

haircuts)

because

taking

this

medicine.

Finasteride AN 1mg tablets are

not addictive.

Before You Take

Finasteride AN 1 mg

tablets

When you must not take

it

Do not take Finasteride AN 1 mg

tablets if:

You

have

an

allergy

to

Finasteride

or

to

any

of

the

ingredients

listed

at

the end of this leaflet

Symptoms of an allergic reaction

include

skin

rash,

swelling of the face and lips.

The packaging is torn or

shows signs of tampering

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

Finasteride AN 1 mg tablets,

talk to your doctor.

Women who are pregnant or

may

be

pregnant

must

not

take

Finasteride

AN

1

mg

tablets,

handle

crushed

or

broken

tablets

or

handle

tablets with wet hands.

active

ingredient

tablet

absorbed

after

swallowing the tablet or through

skin

woman

pregnant

with

male

baby,

may cause the male baby to be

born

with

abnormalities

sex organs.

Whole

tablets

coated

prevent contact with the active

ingredient

during

normal

handling,

provided

that

tablets haven’t been crushed or

broken.

If a pregnant woman swallows

Finasteride AN, handles crushed

broken

tablets

handles

tablets

with

hands,

doctor

must

consulted

immediately.

Do not give Finasteride AN to

children or women.

Finasteride AN is for use by men

only.

Finasteride AN 1mg tablets – Consumer Medicine Information

Finasteride AN CMI v2.0

Page 2

Before you start to take it

Tell your doctor if:

You have or have had any

medical conditions

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

Finasteride AN.

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

other

medicines

work.

However, Finasteride AN 1 mg

tablets has not been shown to

interfere with other medicines.

How to take

Finasteride AN 1 mg

tablets

How much to take

Take

Finasteride

AN

only

when

prescribed

by

your

doctor.

dose

tablet

taken

once each day. Finasteride AN

1mg tablets will not work faster

or better if you take it more than

once a day.

How to take it

Swallow your tablet with a glass

of water.

It does not matter if you take

Finasteride

before

after

food.

Follow all directions given to

you by your doctor carefully.

They

differ

from

information

contained

this

leaflet.

If you do not understand the

instructions on the box, ask

your doctor or pharmacist for

help.

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

the

missed

dose

as

soon

as

you

remember, and then go back

to taking your tablets as you

would normally.

Do not take a double dose to

make

up

for

the

dose

you

missed.

If you are not sure what to do,

ask

your

doctor

or

pharmacist.

If

you

have

trouble

remembering

to

take

your

tablets,

ask

your

pharmacist

for some hints.

How long to take it

Male

pattern

hair

loss

condition that develops over a

long period of time. Because it

takes time for new hair to grow,

will

immediate

results. In general, daily use for

months

more

necessary

before

notice

increased

hair

growth

prevention

further

loss.

Continue taking Finasteride AN

1 mg tablets for as long as your

doctor prescribes

If you stop taking it

stop

taking

tablets

your hair loss is likely to resume.

If you take too much

(overdose)

Immediately

telephone

your

doctor

or

the

Poisons

Information Centre (telephone

13 11 26) for advice, or go to

Accident

and

Emergency

at

the

nearest

hospital,

if

you

think you or anyone else may

have taken

too much Finasteride AN. Do

this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

Finasteride AN 1 mg

tablets

Things you must do

If you are about to be started

on any new medicine tell your

doctor

and

pharmacist

that

you are taking Finasteride AN

1 mg tablets.

Things you must not do

Do not give Finasteride AN 1

mg

tablets

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 Finasteride AN.

Finasteride

tablets

helps

most

with

male

pattern

hair

loss,

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

achieving

erection

Finasteride AN 1mg tablets – Consumer Medicine Information

Finasteride AN CMI v2.0

Page 3

Less desire for sex

Decreased

amount

semen released during sex

(this

decrease

does

appear

interfere

with

normal sexual function).

Each

these

side

effects

occurred in less than two men in

one hundred. It is important to

understand that, in clinical trials,

these

unwanted

effects

disappeared

stopped taking Finasteride AN 1

mg tablets, as well as in many

men who continued treatment.

Also, tell your doctor if you

notice

problems

with

ejaculation and it worries you.

Tell your doctor immediately if

you

notice

any

of

the

following:

Breast

swelling

and/or

tenderness

Skin rash, itchiness

Hives or nettlerash (pinkish,

itchy swellings on the skin)

Testicle pain

These

uncommon

side

effects that have been reported

with

Finasteride

tablets.

Tell your doctor immediately

or

go

to

accident

and

emergency

at

your

nearest

hospital

if

the

following

happens:

swelling of the lips or face.

These may be symptoms of

a serious allergic reaction to

Finasteride AN 1 mg tablets

which may cause difficulty in

swallowing or breathing. You

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

Finasteride AN 1 mg

tablets

Storage

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.

Store

Finasteride

AN

tablets

where the temperature

stays

below 25 degrees 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

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking

the

tablets,

or

your

tablets

have

passed

their

expiry

date,

ask

your

pharmacist

what

to

do

with

any that are left over.

Product description

What it looks like

Finasteride AN 1 mg tablets are

reddish

brown,

round,

biconvex,

film

coated

tablets,

markef F1 on one side and plain

on the other.

They are presented in Al blister

packs

tablets

(AUST

189272).

Ingredients

Active Ingredient:

Finasteride 1 mg per tablet

Other Ingredients:

microcrystalline cellulose

lactose

lauroyl macrogoglycerides

magnesium stearate

pregelatinised maize starch

sodium starch glycolate type

Opadry

complete

film

coating

system

03F34739

Pink

Finasteride AN 1 mg tablets do

contain

gluten,

sucrose,

tartrazine or any other azo dyes.

Name

and

Address

of

the

Sponsor

Amneal

Pharma

Australia

12 River Street

SOUTH YARRA

VIC, 3141

Australia

Date of Preparation

October 2014