IMREST zopiclone 7.5mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

zopiclone, Quantity: 7.5 mg

Beschikbaar vanaf:

Alphapharm Pty Ltd

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: lactose; calcium hydrogen phosphate; magnesium stearate; maize starch; povidone; titanium dioxide; hypromellose; macrogol 400

Toedieningsweg:

Oral

Eenheden in pakket:

30 Tablets, 14 Tablets, 2 Tablets, 100 Tablets, 10 Tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Short-term treatment of insomnia (7 - 14 days).

Product samenvatting:

Visual Identification: White, film coated, oval tablet, embossed Z breakline Z on one side and 7.5 on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Licence status A

Autorisatie datum:

2004-11-30

Bijsluiter

IMREST
®
I
M
R
E
S
T
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IMREST?
IMREST contains the active ingredient zopiclone. IMREST is used to
help people over 18 years 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 (7-14 days) of insomnia.
For more information, see Section 1. Why am I using IMREST? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMREST?
Do not use if you have ever had an allergic reaction to IMREST or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
IMREST? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IMREST and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE IMREST?
•
IMREST should only be taken when you are able to get a full night's
sleep (7 to 8 hours) before you need to be active again.
•
The standard adult dose of IMREST is one tablet just before you go to
bed.
More instructions can be found in Section 4. How do I use IMREST? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMREST?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist who you visit that you are
using IMREST.
•
If you become pregnant while you are taking this medicine, stop taking
it and tell your doctor or
pharmacist immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take more than the recommended dose unless your doctor tells
you.
DRIVING
OR USING
MACHINES
•
Because IMREST will make you sleepy, you should not operate dangerous
machinery or drive motor
vehicles for 12 hours af

Productkenmerken

AUSTRALIAN PRODUCT INFORMATION
IMREST
®
_Zopiclone tablets _
1
NAME OF THE MEDICINE
Zopiclone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IMREST tablet contains 7.5 mg of zopiclone as the active
ingredient.
Excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
IMREST tablets are white, film coated, oval tablets embossed with
“Z” breakline “Z” on one side and “7.5”
on the other.
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.
IMREST should be taken in a single intake and not be readministered
during the same night.
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 WARNING AND PRECAUTIONS FOR
USE – DEPENDENCE
for advice of gradual dose decrease after prolonged use.
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 WARNING AND PRECAUTIONS FOR USE
).
PAEDIATRIC
Zopiclone is contraindicated in children. Dosage has not been
established.
HEPATIC INSUFFICIENCY
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.
IMREST – PRODUCT INFORM