FINAPEN 1 mg finasteride 1 mg film-coated tablet blister pack

Main information

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

Documents

Localization

  • Available in:
  • FINAPEN 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:
  • 189653
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189653

FINAPEN 1 mg finasteride 1 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

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. FINAPEN 1 mg finasteride 1 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

5/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

FINAPEN 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. FINAPEN 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. FINAPEN 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 12:21:48 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

Finapen Consumer Medicine Information

Version 2

Finapen

Finasteride Tablets 1 mg

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Finapen. It does not contain all

the available information.

It does not take the place of

talking

your

doctor

pharmacist.

All medicines have risks and

benefits.

Your

doctor

weighed

risks

taking

Finapen

against

benefits

they

expect

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 Finapen is used

for

Finapen

only.

Finapen 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

androgenetic

alopecia)

common

condition

which

experience thinning of the hair

on the scalp.

This often results in a receding

hair line and/or balding on the

head.

These

changes

typically

start

occur in some men in their 20s

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

thought

caused

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 Finapen works

Finapen specifically lowers the

levels

scalp,

thus

helping

reverse

balding process.

Finapen does not affect hair

on other parts of the body.

with

mild

moderate,

but not complete, hair loss can

expect to benefit from the use

of Finapen.

In women who were studied,

Finapen was not effective in

treatment

hair

loss

(androgenetic alopecia).

There should be no need to

change your usual hair care

routine

(for

example,

shampooing

haircuts)

because

taking

Finapen.

Finapen is not addictive.

Before you take

Finapen

When

you

must

not

take it

Do not take Finapen if:

You

have

an

allergy

to

Finapen

or

any

of

the

ingredients

listed

at

the

end of this leaflet.

Symptoms

allergic

reaction

Finapen

include skin rash, or swelling

of the lips or face.

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

Finapen, talk to your doctor.

Women who are pregnant or

may be pregnant must not

take

Finapen,

handle

crushed or broken tablets or

handle

tablets

with

wet

hands.

active

ingredient

Finapen

absorbed

after

swallowing

tablet

through the skin by a woman

who is pregnant with a male

baby, it may cause the male

baby

born

with

abnormalities

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

Finapen,

handles

crushed or broken tablets or

handles

tablets

with

wet

hands, her doctor must be

consulted immediately.

Finapen Consumer Medicine Information

Version 2

Do

not

give

Finapen

to

children or women.

Finapen

only.

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 Finapen.

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

affect

the way other medicines work.

However,

Finapen

been shown to interfere with

other medicines.

How to take Finapen

How much to take

Take

Finapen

only

when

prescribed by your doctor.

The dose is one tablet taken

once each day. Finapen will

not work faster or better if you

take it more than once a day.

Swallow

Finapen

with

a

glass of water.

It does not matter if you take

Finapen before or 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.

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

condition that develops over a

long period of time. Because it

takes

time

hair

grow,

will

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 Finapen for as

long

your

doctor

prescribes.

If you stop taking it

If you stop taking the tablets

your

hair

loss

likely

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 Finapen. Do

this

even

if

there

are

no

signs

of

discomfort

or

poisoning.

While you are using

Finapen

Things you must do

If

you

are

about

to

be

started

on

any

new

medicine

tell

your

doctor

and pharmacist that you are

taking Finapen.

Things you must not do

Do

not

give

Finapen

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

Finapen.

Finapen helps most men with

male pattern hair loss, but it

have

unwanted

side

effects

men.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

not.

need

medical treatment if you

some of the side effects.

Finapen Consumer Medicine Information

Version 2

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

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

Finapen,

well

many

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

rare

cases,

male

breast

cancer has been reported.

breast

lumps,

pain

discharge from the nipples.

Skin rash, itchiness

Hives or nettlerash (pinkish,

itchy swellings on the skin)

Testicle pain

blood in semen

depressions

(feelings

severe

sadness

unworthiness)

including

suicidal thoughts

These

uncommon

side

effects

that

have

been

reported with Finapen.

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

Finapen,

which

cause

difficulty

swallowing

breathing.

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 using Finapen

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

Finapen

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

dampness

destroy some medicines.

Keep

it

where

children

cannot reach it.

A locked cupboard at least 1½

metres above the ground is a

good place to store medicines.

Disposal

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

Finapen comes as a reddish

brown,

round,

biconvex,

film

coated tablet, marked ‘F1’ on

side

plain

other.

A pack contains 28 tablets.

Ingredients

Active ingredient:

Finasteride 1 mg per tablet

Inactive ingredients:

Lactose monohydrate

Cellulose microcrystalline

Pregelatinised maize

starch

Lauroyl macrogolglycerides

Sodium starch glycollate

type A

Magnesium stearate

Opadry 03F34739 Pink

Finapen

does

contain

gluten, sucrose, tartrazine or

any other azo dyes.

Sponsor

Arrow Pharma Pty Ltd

15-17 Chapel Street

Cremorne

VIC 3121

This leaflet was revised in

March 2019.

AUST R 189653