APO-BETAHISTINE

Main information

  • Trade name:
  • APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217105
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217105

APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

20/10/2014

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. APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack

Product Type

Single Medicine Product

Effective date

5/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting); hearing loss (hardness of hearing); tinnitus.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White or almost white, round, flat bevelled edged tablets embossed "B16"

on one side and scored on the other side.

Active Ingredients

betahistine dihydrochloride

16 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 26.11.2017 at 06:54:59 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

APO-Betahistine

Contains the active ingredient betahistine dihydrochloride

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about betahistine. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Betahistine Tablet. It contains the

active ingredient betahistine

dihydrochloride.

It is used to treat Meniere's

Syndrome, a disorder of the inner

ear.

Meniere's Syndrome may include one

or more of the following symptoms,

in one or both ears:

ringing in the ears (tinnitus)

Loss of clear hearing

Problems with balance (vertigo)

These symptoms may also be

associated with nausea and vomiting.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

Keep this leaflet with your medicine.

You may want to read it again.

How it works

Betahistine works by improving the

blood flow of the inner ear and

restoring it to normal. It also acts on

the nerve endings in the inner ear to

normalise the way in which the

nerves respond to outside influences.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children less than 18 years of age.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

-

pheochromocytoma, a rare

abnormality of the adrenal

gland

-

peptic ulcer.

You are pregnant.

Betahistine may affect your

developing baby if you take it

during pregnancy.

You are breastfeeding.

Betahistine may pass into human

breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

betahistine dihydrochloride or

any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

APO-BETAHISTINE TABLET

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Do not give this medicine to a child

under the age of 18 years.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially

asthma.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding.

.You are planning to have surgery

or an anaesthetic.

.You are currently receiving or

are planning to receive dental

treatment.

.You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

betahistine. These include:

any anti-histamine medications,

which are used to treat allergies

and allergic reactions

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with betahistine.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

The usual adult starting dose is 8 to

16mg taken three times a day.

The maximum total daily dose

recommended is 48mg.

However your doctor may prescribe

a different dose depending on the

severity of your condition.

How to take it

Swallow the tablet with a full glass

of water.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

The tablets may be taken with or

without food. If gastrointestinal upset

occurs, it is recommended that the

tablets be taken with meals.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

If you follow your doctor's

instructions this medicine should

start working within a few days,

although in some cases it may take a

few weeks. The length of time that

you should take this medicine varies

from patient to patient. Some patients

respond rapidly to treatment and

others may take some time. Please be

patient with your treatment and take

your medicine regularly.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise, take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

APO-BETAHISTINE TABLET

you are going to have surgery or

an anaesthetic or are going into

hospital.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking betahistine or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

skin irritations

stomach upsets

dizziness

fast heart beat

headache.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

skin reaction

difficulty breathing.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to betahistine, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine 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

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO-Betahistine

Tablet looks like

16mg Tablet:

White or almost white, round, flat

bevelled edged tablets embossed B16

on one side and scored on the other

side.

Available in blister packs (Clear

PVC/PVDC/Aluminium silver foil)

of 25 tablets.

Ingredients

Each tablet contains 16 mg of

Betahistine as the active ingredient.

It also contains the following inactive

ingredients:

Povidone

Microcrystalline cellulose

Lactose

Colloidal anhydrous silica

Crospovidone

Stearic acid

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

APO-Betahistine 16mg Tablet:

AUST R 217105.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in

October 2014.

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