APO-Zopiclone zopiclone 7.5mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
04-08-2022
Summary of Product characteristics
(SPC)
04-08-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
zopiclone, Quantity: 7.5 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Zopiclone
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: maize starch; purified talc; sodium starch glycollate type A; colloidal anhydrous silica; magnesium stearate; povidone; titanium dioxide; hypromellose; lactose monohydrate; macrogol 6000; calcium hydrogen phosphate dihydrate
Administration route:
Oral
Units in package:
30, 7, 14
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Short term treatment of Insomnia (7 -14 days)
Product summary:
Visual Identification: White to off white oval film coated tablets with breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-09-04
Patient Information leaflet
APO- ZOPICLONE
1
APO- 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 (7-14 days) of insomnia.
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
•
have previously experienced
sleep behaviours when taking
zopiclone
DO NOT TAKE THIS MEDICINE IF YOU
RE
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Summary of Product characteristics
1
AUSTRALIAN
PRODUCT
INFORMATION
–
APO-ZOPICLONE
(ZOPICLONE) TABLETS
1
NAME OF THE MEDICINE
Zopiclone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg of the active ingredient zopiclone.
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 (7 – 14 days).
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral use only.
Use the lowest effective dose for short term treatment (7-14 days).
Extension beyond the maximum treatment period should not take place
without re-evaluation
of the patient's status, since the risk of abuse and dependence
increases with the duration of
treatment.
Zopiclone should be taken in a single intake and not be readministered
during the same
night.
USE IN ADULTS
7.5 mg by oral administration shortly before retiring. This dose
should not be exceeded.
Depending on clinical response, the dose may be lowered to 3.75 mg.
Zopiclone is for short term treatment (7-14 days). _SEE SECTION 4.4
SPECIAL WARNINGS AND _
_PRECAUTIONS FOR USE – DEPENDENCE _for advice of gradual dose
decrease after prolonged
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 Section 4.4 Special warnings and precautions for
use).
2
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
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