Imovane

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Zopiclone 7.5mg; Zopiclone 7.5mg

Dostopno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (mednarodno ime):

Zopiclone 7.5 mg

Odmerek:

7.5 mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Zopiclone 7.5mg Excipient: Calcium hydrogen phosphate dihydrate Ethanol Hypromellose Lactose monohydrate Magnesium stearate Purified water   Sodium starch glycolate Titanium dioxide Wheat starch Active: Zopiclone 7.5mg Excipient: Calcium hydrogen phosphate dihydrate Lactose monohydrate Magnesium stearate Opadry white OY-S-38906 Purified water   Sodium starch glycolate Wheat starch

Enote v paketu:

Blister pack, 1 x 10, 10 tablets

Razred:

Prescription

Tip zastaranja:

Class C5 Controlled Drug

Izdeluje:

Sanofi Chimie

Terapevtske indikacije:

Zopiclone is indicated for the short-term treatment of insomnia in adults.

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Sample - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Datum dovoljenje:

1985-09-26

Navodilo za uporabo

IMOVANE®
1
IMOVANE
®
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 IMOVANE?
Imovane contains the active ingredient zopiclone. Imovane is used to
help people over 18 years of age 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 Imovane?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMOVANE?
Do not use if you have ever had an allergic reaction to Imovane 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
Imovane?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Imovane 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 IMOVANE?
•
Imovane 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 Imovane is one tablet just before you go to
bed.
More instructions can be found in Section 4. How do I use Imovane?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMOVANE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Imovane.
•
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 to.
DRIVING OR USING
MACHINES
•
Because Imovane will make you sleepy, you should not operate dangerous
machinery or drive motor

Lastnosti izdelka

imovane-ccdsv13-dsv16-19dec22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Imovane 7.5 mg film coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imovane tablets contain 7.5 mg of the active ingredient zopiclone.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
The tablets are scored white or almost white, elliptical, biconvex,
film coated tablets.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zopiclone is indicated for the short-term treatment of insomnia in
adults (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.
Imovane 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.
Extension beyond the maximum treatment period should not take place
without re-evaluation of
imovane-ccdsv13-dsv16-19dec22
Page 2
the patient’s status, since the risk of abuse and dependence
increases with the duration of
treatment. 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.
Elderly Patients
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).
Paediatric Population
Zopic