Chemmart

Main information

  • Trade name:
  • Chemmart Zopiclone zopiclone 7.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Chemmart Zopiclone zopiclone 7.5mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213074
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213074

Chemmart Zopiclone zopiclone 7.5mg 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

4/09/2014

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. Chemmart Zopiclone zopiclone 7.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

15/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Short term treatment of Insomnia (2 - 4 weeks)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Chemmart Zopiclone zopiclone 7.5mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white oval film coated tablets with breakline on one side and

plain on the other side.

Active Ingredients

Zopiclone

7.5 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 26.11.2017 at 11:35:16 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

CHEMMART

ZOPICLONE

Contains the active ingredient zopiclone

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 zopiclone. 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

Chemmart Zopiclone Tablet. It

contains the active ingredient

zopiclone.

It is used to help people with

sleeping difficulties, also called

insomnia. It can help you fall asleep

and to reduce the number of times

you wake up during the night. It is

used for short term treatment (2-4

weeks) of insomnia. It is not

recommended for use for more than 4

weeks at a time.

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.

Use in children

This medicine should not be used in

children. The safe and effective dose

of this medicine in children and

adolescents under 18 years of age has

not been established.

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:

-

sleep apnoea (a condition where

you temporarily stop breathing

while you sleep)

-

myasthenia gravis (a condition

in which the muscles become

weak and tire easily)

-

severe liver problems

-

severe lung problems.

You recently had alcohol or

believe that you may have

alcohol in your bloodstream.

You have had a stroke.

You are hypersensitive to, or

have had an allergic reaction to,

zopiclone 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

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.

CHEMMART ZOPICLONE TABLETS

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Do not give this medicine to

children or adolescents under 18

years of age

The safe and effective dose of this

medicine in children and adolescents

under 18 years of age has not been

established.

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 the

following:

thyroid problems

depression, psychosis or

schizophrenia

epilepsy

kidney problems

liver problems

lung problems or breathing

problems.

You have a disability.

You are or have been addicted to

alcohol or any drug or medicine.

You frequently consume alcohol.

You are taking medication for a

mental illness.

You are currently pregnant or you

plan to become pregnant.

Do not take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed.

Do not take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have surgery

or an anaesthetic.

10. You are currently receiving or are

planning to receive dental

treatment.

11. 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

zopiclone. These include:

medicines to treat depression,

anxiety and mental illness

other sedatives or tranquillisers

strong pain relievers, such as

codeine

muscle relaxants

antihistamines

antipsychotics

antiepileptics such as

carbamazepine, phenobarbital and

phenytoin

certain antibiotics such as

rifampicin, clarithromycin and

erythromycin

ketoconazole and itraconazole,

medicines to treat fungal

infections

ritonavir, used to treat HIV

St John's Wort.

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 zopiclone.

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 standard adult dose is one tablet

just before you go to bed.

Elderly people and people with liver

problems may need smaller doses.

Your doctor may have prescribed a

different dose. This depends on your

condition and whether or not you are

taking any other medicines.

This medicine should not be given

to children or adolescents less than

18 years of age.

How to take it

Swallow the tablet with a full glass

of water.

When to take it

This medicine should be taken when

you are able to have a full night sleep

and immediately before you go to

bed. It helps put you to sleep quite

quickly.

If you take this medicine on an

empty stomach it may work more

quickly.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

This medicine should only be used

for short periods (eg 2 to 4 weeks).

Continuous long term use is not

recommended unless advised by your

doctor.

If you forget to take it

If you forget to take the tablet before

you go to bed, and you wake up late

in the night or very early in the

morning, do not take it.

You may have trouble waking at

your normal time.

Take the next dose the following

night when you are meant to.

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:

CHEMMART ZOPICLONE TABLETS

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

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Take more than the recommended

dose unless your doctor tells you

to. This can increase the risk of

side effects.

Take for a longer time than the

doctor has prescribed.

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.

Drink alcohol before or after

taking this medicine. Do not

drink alcohol with this medicine.

Things to be careful of

This medicine will cause

drowsiness. You should not

operate dangerous machinery or

drive motors for 8 hours after you

take it. You should be careful the

next morning when you wake up.

Make sure you know how you react

to this medicine before you drive a

car or operate machinery. This is

very important if you are taking other

drugs that also make you drowsy.

Be careful if you are over 65 and

unwell or taking other medicines.

You may be more sensitive to some

of the side effects of this medicine.

You should not drink alcohol while

you are taking this medicine.

The effects of alcohol could be made

worse while taking this medicine.

Some medicines can cause

dependence, especially when they are

used regularly for longer than a few

weeks. People who have been

dependent on alcohol or other drugs

in the past may have a higher chance

of becoming addicted to sleep

medicines. If you have been addicted

to alcohol or drugs in the past, it is

important to tell your doctor before

starting this medicine.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking zopiclone 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:

headaches

dry mouth

bitter taste in your mouth

drowsiness

fatigue

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:

heartburn

nausea, vomiting and/or diarrhoea

change in appetite

stomach pain

rash

agitation

depression

confusion

anxiety

dizziness

blurred vision

impotence

sleep walking or other behaviours

whilst asleep

Alcohol can increase the risk of sleep

walking or other behaviours such as

driving or eating food whilst asleep.

This risk is also increased if you take

more than the recommended dose.

Some sleep medicines may cause a

short-term memory loss. When this

occurs, a person may not remember

what has happened for several hours

after taking the medicine. This is

usually not a problem since most

people fall asleep after taking the

medicine.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to zopiclone, 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

CHEMMART ZOPICLONE TABLETS

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

After taking it

Sometimes when medicines are

stopped suddenly, after being used

for a long time, withdrawal

symptoms may occur. Symptoms of

withdrawal may include insomnia,

confusion, headache, muscle cramps

and sweating.

Tell your doctor if you have any

problems when you stop taking this

medicine.

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. Protect from light.

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 Chemmart Zopiclone

tablets looks like

7.5mg film-coated tablets

White to off white oval film coated

tablets with breakline on one side and

plain on the other side.

Blister packs of 30 tablets

Ingredients

Each tablet contains 7.5 mg of

zopiclone as the active ingredient.

It also contains the following inactive

ingredients:

calcium hydrogen phosphate

lactose

sodium starch glycollate type A

povidone

maize starch

colloidal anhydrous silica

magnesium stearate

hypromellose

macrogol 6000

titanium dioxide

purified talc

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

Chemmart Zopiclone 7.5mg Tablets

(Blisters): AUST R 213074.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in

September 2014

CHEMMART ZOPICLONE TABLETS