Chemmart Zopiclone zopiclone 7.5mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
12-06-2019
Summary of Product characteristics
(SPC)
12-06-2019
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
zopiclone
Available from:
Apotex Pty Ltd
INN (International Name):
Zopiclone
Authorization status:
Registered
Patient Information leaflet
CHEMMART
ZOPICLONE
_Zopiclone_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
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.
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.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Zopiclone is used to help people with
sleeping difficulties (insomnia). It
helps you fall asleep and reduces 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.
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 AN ALLERGY TO:
•
zopiclone
•
any of the ingredients listed at the
end of this leaflet.
Some of the 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
•
hay fever-like symptoms.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
sleep apnoea
•
myasthenia gravis
•
severe liver problems
•
severe lung problems.
•
stroke
DO NOT TAKE THIS MEDICINE IF YOU
RECENTLY HAD ALCOHOL OR BE
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –CHEMMART ZOPICLONE
(ZOPICLONE) TABLETS
1
NAME OF THE MEDICINE
Zopiclone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg of the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
The tablets are white to off white oval film coated tablets with
breakline on one side and plain
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term treatment of insomnia (2 to 4 weeks).
4.2
DOSE AND METHOD OF ADMINISTRATION
USE IN ADULTS
7.5 mg by oral administration shortly before retiring for a maximum of
2-4 weeks. This dose
should not be exceeded. Depending on clinical response, the dose may
be lowered to 3.75
mg. Zopiclone is not recommended for long term use (i.e. periods of
more than 4 weeks). If
used for long periods, treatment should be withdrawn gradually. (See
‘4.4 Special warnings
and precautions for use’)
USE IN THE ELDERLY
In the elderly and/or debilitated patient an initial dose of 3.75 mg
is recommended. The dose
may be increased to a maximum of 7.5 mg if the starting dose does not
offer adequate
therapeutic effect, but in clinical trials, 25% of elderly patients
treated with zopiclone
experienced CNS side-effects at the higher dose. Zopiclone should be
used with caution in
these patients. (See also ‘4.4 Special warnings and precautions for
use’).
USE IN CHILDREN
Zopiclone is contraindicated in children. Dosage has not been
established.
USE IN PATIENTS WITH RENAL IMPAIRMENT
In patients with renal insufficiency: although no accumulation of
zopiclone or of its metabolites
has been detected in cases of renal insufficiency, it is recommended
that patients with
impaired renal function should start treatment with 3.75 mg.
2
USE IN PATIENTS WITH HEPATIC IMPAIRMENT
The recommended dose is 3.75 mg depending on acceptability and
efficacy. Up to 7.5 mg
may be used with caution in appropriate cases.
ALTERNATIVE THERAPY
For long term t
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