AURO-ONDANSETRON 4

Main information

  • Trade name:
  • AURO-ONDANSETRON 4
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AURO-ONDANSETRON 4
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173184
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173184

AURO-ONDANSETRON 4 ondansetron (as hydrochloride dihydrate) 4mg 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

29/09/2011

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. AURO-ONDANSETRON 4

Product Type

Single Medicine Product

Effective date

10/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval shaped, film-coated tablets debossed with 'E' on

one side and '01' on the other side.

Active Ingredients

Ondansetron hydrochloride dihydrate

4.986 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 04:37:40 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

AURO-ONDANSETRON

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 1 of 3

AURO-ONDANSETRON 4 & 8

Ondansetron (as hydrochloride dihydrate)

Consumer Medicine Information

What is in this leaflet

Please

read

this

leaflet

carefully

before

AURO-

ONDANSETRON.

This

leaflet

answers some

common

questions

about

AURO-

ONDANSETRON. It does not contain

all of the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the expected

benefits

taking

AURO-

ONDANSETRON

against

risks

this could 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 AURO-

ONDANSETRON used for

AURO-ONDANSETRON contains a

medicine

called

ondansetron.

This

belongs

group

medicines

called

serotonin

receptor-3

antagonists.

AURO-ONDANSETRON are used to

help stop the nausea (sick feeling) and

vomiting

which

occur

after

medical treatments and operations.

AURO-ONDANSETRON

should

only be used to treat the nausea and

vomiting for which they have been

prescribed.

Your

doctor

have

prescribed

AURO-ONDANSETRON for another

reason. If you want more information,

ask your doctor.

AURO-ONDANSETRON

addictive.

Before you take

AURO-ONDANSETRON

Do not take if:

must

take

AURO-

ONDANSETRON if:

you

have

ever

had

an

allergic

reaction to ondansetron or any of

the ingredients listed toward the

end

of

this

leaflet.

(See"Ingredients")

you

are

pregnant,

trying

to

become

pregnant

or

breastfeeding, unless your doctor

says it is safe.

the

expiry

date

printed

on

the

pack has passed.

the packaging is torn or shows

signs of tampering

Tell your doctor if:

You must tell your doctor if:

you

are

allergic

to

foods,

dyes,

preservatives

or

any

other

medicines.

you

have

had

to

stop

taking

another medicine for your nausea

or vomiting.

you

are

taking

any

other

medicines,

including

medicines

you buy without a prescription.

you have or used to have liver

problems.

You are breastfeeding, pregnant

or trying to become pregnant.

Some medicines may affect the way

others

work.

Your

doctor

pharmacist will be able to tell you

what

when

taking

AURO-

ONDANSETRON

with

other

medicines.

How to take

AURO-ONDANSETRON

How

much

to

take

AURO-

ONDANSETRON

Take

AURO-ONDANSETRON

directed by your doctor or pharmacist.

Do

NOT

take

MORE

TABLETS

than

your

doctor

or

pharmacist

tells you.

Do

NOT

take

the

tablets

MORE

OFTEN

than

your

doctor

or

pharmacist tells you.

If you vomit within one hour taking

your

first

AURO-ONDANSETRON

of each course prescribed to you, you

should take the same dose again. If

continue

vomit,

tell

your

doctor.

How

to

take

AURO-

ONDANSETRON

Swallow each tablet with a drink of

water. Do not crush the tablet. If you

have trouble swallowing your tablet,

please tell your doctor.

How

long

to

take

AURO-

ONDANSETRON for

Do

not

stop

taking

AURO-

ONDANSETRON,

or

change

the

dose

without

first

checking

with

your doctor.

If

you

forget

to

take

AURO-

ONDANSETRON

If you miss your dose and you do not

feel sick, take your next dose when

you are meant to

If you miss your dose and you feel

sick, take the missed dose as soon as

possible, then go back to taking your

AURO-ONDANSETRON

would normally. 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 you take too much (overdose)

Immediately telephone your doctor

or

Poisons

Information

Centre

(telephone

131126)

for

advice,

if

you think you or anyone else may

have

taken

too

much

AURO-

ONDANSETRON, even if there are

no signs of discomfort or poisoning.

If

you

are

not

sure

what

to

do,

contact your doctor or pharmacist.

AURO-ONDANSETRON

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 2 of 3

While you are taking

AURO-ONDANSETRON

Things you must do

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as directed.

Otherwise, your doctor may think that

it was not working as it should and

change your treatment unnecessarily.

Things you must not do

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do

not

use

AURO-

ONDANSETRON

to

treat

any

other complaints unless your doctor

says to.

Side Effects

Check with your doctor as soon as

possible

if

you

think

you

are

experiencing

any

side

effects

or

allergic

reactions

due

to

taking

AURO-ONDANSETRON,

even

if

the problem is not listed below.

Like

other

medicines,

AURO-

ONDANSETRON

cause

some

side effects. If they occur, they are

most

likely

minor

temporary.

However,

some

serious and need medical attention.

most

commonly

reported

side-

effects are:

headache

a sensation of warmth or flushing

mild stomach cramps

constipation or diarrhoea

dry mouth

hiccups

These are all mild side effects. There

is no immediate reason to stop taking

your tablets unless you are concerned.

Tell your doctor immediately if you

notice any of the following:

'wheezy' symptoms

chest

pain

or

tightness

of

the

chest

changes

in

the

way

your

heart

beats, e.g. if you notice it beating

faster or slower than normal, or

if

it

beats

irregularly

or

if

it

'throbs'

low blood pressure

fits or convulsions

swelling of the eyelids, face, lips,

mouth or throat which may cause

difficulty

in

swallowing

or

breathing

skin rash, skin lumps or hives

These

are

all

serious

side

effects.You

may

need

urgent

medical

attention.

Serious

side

effects are rare.

This

complete

list

possible

side

effects.

Others

occur in some people and there may

be some side effects not yet known.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

If your nausea (feeling of sickness)

or vomiting does not go away, ask

your doctor what to do.

certain

illnesses

treatments

where AURO-ONDANSETRON has

been used, blood vessel blockage has

occurred.

However, it is important to note that

blood

vessel

blockage

also

occurred

these

illnesses

treatments

when

AURO-

ONDANSETRON

have

been

used. Discuss this with your doctor if

you have any concerns.

feel

unwell

have

symptoms that you do not understand,

should

tell

your

doctor

immediately.

After taking

AURO-ONDANSETRON

Keep this medicine where children

cannot reach it, such as in a locked

cupboard.

Keep AURO-ONDANSETRON in a

cool, dry place where it stays below

25 degrees C, and away from bright

sunlight.

Do not leave in a car, on window sill

or in bathroom.

Keep

AURO-ONDANSETRON

in

their blister pack until time to take.

Return

any

unused

or

expired

medicine to your pharmacist.

Product Description

What it looks like

AURO-ONDANSETRON 4 & 8 (4 &

ondansetron

as hydrochloride

dihydrate) are presented in pack size

of 4, 10, 30 & 90 tablets in blister.

AURO-ONDANSETRON 4 (AUST R

173184)

White to off-white, oval shaped, film-

coated tablets debossed with ‘E’ on

one side and ‘01’ on the other side.

AURO-ONDANSETRON 8 (AUST R

173182)

Yellow

colored,

oval

shaped,

film-

coated tablets debossed with ‘E’ on

one side and ‘02’ on the other side.

Ingredients

Active Ingredient:

Ondansetron hydrochloride dihydrate

Each tablet contains either 4 mg or 8

mg of Ondansetron.

Other Ingredients:

Lactose anhydrous

Cellulose microcrystalline

Magnesium stearate

Starch-pregelatinised maize

tablet

also

contains

glycerol triacetate, titanium dioxide

and hypromellose.

tablet

also

contains

Opadry

yellow

03K52033

(PI-

ARTG No. 106488).

Please

read

this

leaflet

carefully

before

start

taking

AURO-

ONDANSETRON.

wish

to keep it to read again.

AURO-ONDANSETRON

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 3 of 3

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

27 September 2011