Zopiclone Actavis

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Zopiclone 3.75mg;  

Disponible des:

Teva Pharma (New Zealand) Limited

Designació comuna internacional (DCI):

Zopiclone 3.75 mg

Dosis:

3.75 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Zopiclone 3.75mg   Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Hypromellose Indigo carmine aluminium lake Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate Titanium dioxide

tipo de receta:

Class C5 Controlled Drug

Fabricat per:

Centaur Pharmaceuticals Private Limited

indicaciones terapéuticas:

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

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/Al in outer cardboard carton - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Al in outer cardboard carton - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, white HDPE, with white screw cap and cap liner - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, white HDPE, with white screw cap and cap liner - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Data d'autorització:

2013-06-14

Fitxa tècnica

Version 1.1
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Zopiclone Actavis
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.75 mg or 7.5 mg of zopiclone.
Excipient with known effect:
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Zopiclone Actavis 3.75 mg tablets are blue coloured, round biconvex
film coated tablets, plain on
both sides.
Zopiclone Actavis 7.5 mg tablets are white to off-white, oval shaped
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 in adults (7-14 days).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
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 Actavis 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 the patient’s
status, since the risk of abuse and dependence increases with the
duration of the 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.
SPECIAL POPULATIONS
_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 Special
warni