Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Zopiclone 3.75mg;
Teva Pharma (New Zealand) Limited
Zopiclone 3.75 mg
3.75 mg
Film coated tablet
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
Class C5 Controlled Drug
Centaur Pharmaceuticals Private Limited
Short term treatment of insomnia in adults (7-14 days).
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
2013-06-14
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 Прочитајте комплетан документ