ONSETRON ODT 4 ondansetron 4 mg orally disintegrating tablet blister pack

Main information

  • Trade name:
  • ONSETRON ODT 4 ondansetron 4 mg orally disintegrating tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ONSETRON ODT 4 ondansetron 4 mg orally disintegrating tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176761
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176761

ONSETRON ODT 4 ondansetron 4 mg orally disintegrating tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

13/12/2011

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. ONSETRON ODT 4 ondansetron 4 mg orally disintegrating tablet blister pack

Product Type

Single Medicine Product

Effective date

20/05/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Al/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

4 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

White, round 6.6 mm plus-minus 0.2 mm diameter flat-faced bevel-edged

oral dispersible tablets

Active Ingredients

Ondansetron

4 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 12:33:03 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

CMI 030414

ONSETRON

®

ODT

contains the active ingredient ondansetron

CONSUMER MEDICINE INFORMATION

What is in this leaflet?

Please read this leaflet carefully

before you start taking ONSETRON

ODT.

This leaflet answers some common

questions about ONSETRON ODT. 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 risks of

you taking ONSETRON ODT against

the benefits this medicine is expected

to 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 ONSETRON ODT are

used for

ONSETRON ODT belongs to a group

of medicines called antiemetics.

ONSETRON ODT works by helping

to stop the nausea (sick feeling) and

vomiting which can occur after

certain treatments. ODT used in the

product name stands for Oral

Dispersible Tablet. This type of tablet

is placed on the tongue where it is

rapidly dispersed and can then be

swallowed with or without water. It is

easier to swallow than ordinary

tablets. ONSETRON ODT should

only be used to treat the nausea and

vomiting for which it has been

prescribed.

Your doctor may have prescribed

ONSETRON ODT for another

reason.

Ask your doctor if you have any

questions about why ONSETRON

ODT has been prescribed for you.

ONSETRON ODT is not addictive.

Before you take ONSETRON

ODT

When you must not take them

Do not take ONSETRON ODT if

you are taking apomorphine (used

to treat Parkinson’s disease).

Do not take ONSETRON ODT if

you have ever had an allergic

reaction to ondansetron or any of

the ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction may

be mild or severe. They usually

include some or all of the following:

wheezing, swelling of the lips/mouth,

difficulty in breathing, hayfever,

lumpy rash ("hives") or fainting.

Do not take ONSETRON ODT if

you are pregnant, trying to become

pregnant or breastfeeding, unless

your doctor says you should.

Your doctor will discuss the risks and

benefits of using ONSETRON ODT

if you are pregnant or breastfeeding.

Do not take ONSETRON ODT

after the expiry date (EXP) printed

on the pack.

If you take it after the expiry date has

passed, it may not work as well.

Do not take ONSETRON ODT if

the packaging is torn or shows signs

of tampering.

If you're not sure whether you

should be taking ONSETRON

ODT, talk to your doctor.

Before you start to take them

You must tell your doctor if:

you are allergic to foods, dyes,

preservatives or any other

medicines.

you have, or used to have, liver

problems

you suffer from severe

constipation or have a blockage

in your gut

you have phenylketonuria, as

ONSETRON ODT contains

aspartame.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may be affected by

ONSETRON ODT, or may affect

how well it works. These include:

medicines to treat epilepsy

tramadol, a pain reliever

Your doctor or pharmacist will be

able to tell you what to do if you are

taking any of these medicines.

If you are not sure whether you are

taking any of these medicines, check

with your doctor or pharmacist.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

ONSETRON ODT.

Use in children

There is limited experience in

children. ONSETRON ODT can be

taken by children over 4 years of age.

How to take

ONSETRON

ODT

Follow all directions given to you by

your doctor and pharmacist

carefully.

CMI 030414

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the packaging, ask

your doctor or pharmacist for help.

How much to take

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 of

taking your first ONSETRON ODT

of each course prescribed for you, you

should take the same dose again. If

you continue to vomit, tell your

doctor.

How to take them

Place the ONSETRON ODT on top of

your tongue. It will disperse very

quickly, then swallow as normal.

When to take them

Your doctor or pharmacist will be

able to tell you when you should take

your ONSETRON ODT.

How long to take them

Your doctor or pharmacist will be

able to tell you how long you should

take your ONSETRON ODT.

If you forget to take them

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

ONSETRON ODT as you 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

If you take too much

(overdose)

Immediately telephone your doctor,

or the Poisons Information Centre

(telephone 13 11 26), or go to

Accident and Emergency at the

nearest hospital, if you think you or

anyone else may have taken too

much ONSETRON ODT. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

ONSETRON ODT

Things you must do

Before starting any new medicine,

tell your doctor or pharmacist that

you are taking ONSETRON ODT.

Tell your doctor if you become

pregnant or are trying to become

pregnant.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed.

Otherwise, your doctor may think that

it was not effective 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 ONSETRON ODT to

treat any other complaints unless

your doctor says to.

Side-Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

ONSETRON ODT.

Like other medicines, ONSETRON

ODT can cause some side-effects. If

they occur, they are most likely to be

minor and temporary. However, some

may be serious and need medical

attention.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

headache

a sensation of warmth or flushing

mild stomach cramps

constipation or diarrhoea

dry mouth

hiccups

dizziness or light-headed feeling

Tell your doctor or pharmacist

immediately if you notice any of the

following:

chest pain or tightness of 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

abnormal muscular body

movements or shaking

involuntary upward movement of

the eyes

unusual muscle tone causing

distortion of the body

fits or convulsions

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

If you think you are having an

allergic reaction to ONSETRON

ODT, tell your doctor immediately

or go to the casualty department of

your nearest hospital.

Symptoms usually include some or all

of the following:

wheezing

swelling of the lips/mouth

difficulty in breathing

hay fever

lumpy rash ("hives")

fainting

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feeling unwell, even if it is not on

this list.

Do not be alarmed by this list of

possible side-effects. You may not

experience any of them.

If your nausea or vomiting does not

go away, ask your doctor what to

do.

In certain illnesses and treatments

where ONSETRON ODT has been

used, blood vessel blockage has

CMI 030414

occurred. However, it is important to

note that blood vessel blockage has

also occurred in these illnesses and

treatments when ONSETRON ODT

has not been used. Discuss this with

your doctor if you have any concerns.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

After taking ONSETRON

ODT

Storage

Keep this medicine where young

children cannot reach it.

A locked cupboard at least one-and-a

half metres above the ground is a

good place to store medicines.

Keep ONSETRON ODT in a cool,

dry place where it stays below

25°C.

Do not store it, or any other

medicine, in a bathroom or near a

sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep your ONSETRON ODT in their

pack until it is time to take them.

If taken out of their pack, they may

not keep well.

Disposal

If your doctor tells you to stop

taking ONSETRON ODT, or they

have passed their expiry date, ask

your pharmacist what to do with

any left over.

Product description

What it looks like

ONSETRON ODT is a special type of

tablet called an Oral Dispersible

Tablet.

ONSETRON ODT 4 mg tablet is a

white, round, flat-faced, bevel-edged

tablet. It is available in blister packs

of 4 or 10 tablets.

ONSETRON ODT 8 mg tablet is a

white, round, flat-faced, bevel-edged

tablet. It is available in blister packs

of 4 or 10 tablets.

Ingredients

Each ONSETRON ODT contains 4

mg or 8 mg of the active ingredient

ondansetron.

The inactive ingredients are:

Lactose

Hydroxypropylcellulose

Crospovidone

Calcium silicate

Aspartame

Peppermint NAEFCO P0551

957685 (ARTG 2890) flavour

Colloidal anhydrous silica

Magnesium stearate.

ONSETRON ODT tablets do not

contain gluten.

Sponsor

Medis Pharma Pty Ltd

Level 3, 5 Essex St

The Rocks NSW 2000

Australia

Distributor

Actavis Pty Ltd

Level 5, 117 Harrington St

The Rocks NSW 2000

Australia

Phone: 1800 554 414

Australian Registration

Numbers

ONSETRON ODT 4 mg

:

AUST R

176761

ONSETRON ODT 8 mg: AUST R

176762

Date of preparation:

3 April 2014

® Registered Trade Mark