AUROBINDO

Main information

  • Trade name:
  • AUROBINDO FINASTERIDE finasteride 5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUROBINDO FINASTERIDE finasteride 5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210613
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210613

AUROBINDO FINASTERIDE finasteride 5 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

30/04/2014

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. AUROBINDO FINASTERIDE finasteride 5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

24/12/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

AUROBINDO FINASTERIDE is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 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

Components

1. AUROBINDO FINASTERIDE finasteride 5 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Blue coloured, circular, biconvex, bevel edged film-coated tablets debossed

with 'E' on side and '61' on the other side

Active Ingredients

Finasteride

5 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 27.11.2017 at 09:17:24 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

AUROBINDO FINASTERIDE 5

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 1 of 3

AUROBINDO FINASTERIDE 5

Finasteride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions

about

AUROBINDO

FINASTERIDE

does

contain all the available information.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

risks

taking

AUROBINDO

FINASTERIDE

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 AUROBINDO

FINASTERIDE 5 is used for

AUROBINDO FINASTERIDE 5 is

for use by men only.

AUROBINDO FINASTERIDE 5 is

used to treat a medical condition in

called

benign

prostatic

hyperplasia

BPH.

condition where your prostate gland

(which

near

your

bladder)

become

bigger

making

more

difficult for you to pass urine. This

can lead to symptoms such as:

weak

interrupted

stream

urine

feeling

that

cannot

empty

your bladder completely

delay before you start to pass urine

needing

pass

urine

often,

especially at night

feeling that you must pass urine

right away

occurs

only

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

need

surgery

such

procedures to improve the flow of

urine.

prostate

gland

takes

years

grow. Therefore, the symptoms of

BPH take a long time to develop.

AUROBINDO

FINASTERIDE

works by slowly reducing the size of

your prostate gland. This may lead to

gradual improvement in your urine

flow

other

symptoms

over

several

months.

AUROBINDO

FINASTERIDE 5 also helps reduce

risk

developing

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

have

prescribed

AUROBINDO FINASTERIDE 5 for

another reason. Ask your doctor if

you have any questions about why

AUROBINDO

FINASTERIDE

been

prescribed

you.

AUROBINDO FINASTERIDE 5 is

not addictive.

Before you take

AUROBINDO

FINASTERIDE 5

When you must not take it

Do

not

take

AUROBINDO

FINASTERIDE 5 if:

you

have

an

allergy

to

AUROBINDO

FINASTERIDE

5 or any of the ingredients listed

at the end of this leaflet

Symptoms of an allergic reaction

to AUROBINDO FINASTERIDE

include

skin

rash,

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 AUROBINDO

FINASTERIDE

5,

talk

to

your

doctor.

Women who are pregnant or may

be

pregnant

must

not

take

AUROBINDO FINASTERIDE 5,

handle crushed or broken tablets.

active

ingredient

AUROBINDO FINASTERIDE 5 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

organs.

AUROBINDO

FINASTERIDE

tablets are coated and will prevent

contact

with

active

ingredient

during

normal

handling,

provided

that

tablets

broken or

crushed.

If

a

pregnant

woman

swallows

AUROBINDO FINASTERIDE 5,

handles crushed or broken tablets,

her

doctor

must

be

consulted

immediately.

Do

not

give

AUROBINDO

FINASTERIDE 5 to children or

women.

condition

which

AUROBINDO FINASTERIDE 5 is

prescribed occurs only in men.

Before you start taking it

Tell your doctor if:

1.

you

have

or

have

had

any

medical conditions

2.

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 AUROBINDO

FINASTERIDE 5.

AUROBINDO FINASTERIDE 5

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 2 of 3

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,

AUROBINDO

FINASTERIDE

has not been shown to interfere with

other medicines.

Driving and operating

machinery

AUROBINDO

FINASTERIDE

should not affect your ability to drive

or operate machinery.

How to take

AUROBINDO

FINASTERIDE 5

How much to take

Take

AUROBINDO

FINASTERIDE

5

only

when

prescribed by your doctor.

The usual dose in men is one tablet

taken once each day.

Swallow

AUROBINDO

FINASTERIDE 5 with a glass of

water.

Follow all directions given to you

by your doctor carefully.

They

differ

from

information contained in this leaflet.

If

you

do

not

understand

the

instructions on the box, ask your

doctor or pharmacist for help.

When to take it

Take

AUROBINDO

FINASTERIDE 5 once a day at

about the same time each day.

This will help you to remember to

take the tablets.

does

matter

take

AUROBINDO

FINASTERIDE

before or after food.

How long to take it

AUROBINDO

FINASTERIDE

shrinks

prostate

gland

slowly.

Therefore,

need

take

AUROBINDO FINASTERIDE 5 for

6 months or longer to see whether it

helps

you.

does

help

your

symptoms,

need

take

AUROBINDO

FINASTERIDE

every day.

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

AUROBINDO

FINASTERIDE 5. Do this even if

there are no signs of discomfort or

poisoning.

While you are taking

AUROBINDO

FINASTERIDE 5

Things you must do

Go

to

your

doctor

for

regular

checkups,

including

a

physical

check for prostate cancer once a

year if you are over 50.

While BPH is not cancer and does

lead

cancer,

conditions

exist

same

time.

AUROBINDO FINASTERIDE 5 is

used for BPH not prostate cancer.

If you are having a blood test to

measure

your

PSA

(prostatespecific

antigen)

levels,

tell

your

doctor

you

are

taking

AUROBINDO FINASTERIDE 5.

Things you must not do

Do

not

give

AUROBINDO

FINASTERIDE 5 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

AUROBINDO FINASTERIDE 5.

AUROBINDO

FINASTERIDE

helps most men with BPH, but it

may have unwanted side effects in a

few people. All medicines can have

side

effects.

Sometimes

they

serious, most of the time they are

not.

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

have

erection)

that

continues

after

stopping

AUROBINDO

FINASTERIDE 5

less desire for sex that continued

after

stopping

AUROBINDO

FINASTERIDE 5

problems

with

ejaculation

that

continued

after

stopping

medicationChanges

problems

with

ejaculation,

such

decreased

amount

semen

released during sex (this decrease

does not appear to interfere with

normal sexual function).

Male infertility and/or poor quality

semen

have

been

reported

infrequently.

Improvement

quality of semen has been reported

after

stopping

AUROBINDO

FINASTERIDE 5.

AUROBINDO FINASTERIDE 5

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 3 of 3

These

more

common

side

effects

AUROBINDO

FINASTERIDE 5. For the most part

these have been mild. In some cases,

these side effects disappeared while

patient

continued

take

AUROBINDO FINASTERIDE 5. 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

discharge

from the nipples

skin rash, itchiness

hives or nettlerash (pinkish, itchy

swellings on the skin)

testicle pain

depressions

(feelings

severe

sadness and unworthiness)

These

uncommon

side

effects

that

have

been

reported

with

AUROBINDO FINASTERIDE 5.

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

AUROBINDO

FINASTERIDE 5, which may cause

difficulty

swallowing

breathing.

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 using

AUROBINDO

FINASTERIDE 5

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.

Keep

AUROBINDO

FINASTERIDE

5

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

dampness

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 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

AUROBINDO FINASTERIDE 5 (5

mg finasteride tablets) are supplied

in pack sizes of 28 and 30 tablets in

blister packs.

AUROBINDO FINASTERIDE 5

(AUST R: 210613)

Blue

coloured,

circular,

biconvex,

bevel

edged

film-coated

tablets

debossed with ‘E’ on side and ‘61’

on the other side.

Ingredients

Active ingredient

finasteride 5 mg per tablet

Inactive ingredients

lactose

microcrystalline cellulose

pregelatinised maize starch

sodium starch glycollate type A

docusate sodium

magnesium stearate

opadry

complete

film

coating

system 20A50535 blue contains:

hypromellose,

hydroxypropylcellulose,

titanium

dioxide,

talc,

indigo

carmine

CI73015

iron

oxide

yellow

CI77492.

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, Macquarie Link

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

11 April 2014

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

4-7-2012

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.