Apo-Zopiclone

Apo-Zopiclone

zopiclone

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Zopiclone
Indications/Uses
Symptomatic relief of transient & short-term insomnia.
Dosage/Direction for Use
Duration of treatment: Should not exceed 7-10 consecutive days. Adult 7.5 mg at bedtime. Elderly &/or debilitated patient Initially 3.75 mg at bedtime. May be increased to 7.5 mg. Hepatic impairment or chronic resp insufficiency 3.75 mg at bedtime, may be used up to 7.5 mg depending on acceptability & efficacy.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ myasthenia gravis, sleep apnea syndrome & severe hepatic insufficiency; who previously manifested paradoxical reactions to alcohol &/or sedative medications.
Special Precautions
Do not use for insomnia where disturbed sleep results in impaired daytime functioning. History of substance or alcohol abuse. Unrecognized psychiatric or physical disorder. Potential anterograde, transient global & traveller's amnesia; do not use under circumstances in which a full night’s sleep & drug clearance from the body are not possible before resuming to full activity. Patients w/ history of violent behavior & of unusual reactions to sedatives including alcohol & benzodiazepines or benzodiazepine-like agents. Increased daytime anxiety &/or restlessness. Patients w/ depression signs & symptoms. Discontinue use for patients w/ somnambulism & other associated behaviours. Avoid abrupt discontinuation. Hepatic or renal impairment, or severe pulmonary insufficiency. Patients w/ compromised resp function. May impair ability to operate machinery or drive a motor vehicle. May cause fetal damage when used during pregnancy. Not recommended during lactation. Higher risk of confusion in the elderly & patients w/ cerebral impairment. Monitor elderly for potential inappropriate heavy sedation which may result in accidental event/falls. Not for patients <18 yr.
Adverse Reactions
Bitter taste. Somnolence, asthenia, dizziness, confusion, anterograde amnesia or memory impairment, feeling of drunkenness, euphoria, anxiety or nervousness, depression, coordination abnormality, hypotonia, speech disorder.
Drug Interactions
Potential additive CNS depressant effects in co-administration w/ alcohol, sedative antihistamines, anticonvulsants, or psychotropics. Zopiclone activity may be enhanced w/ cytochrome P450 inhibiting compd (eg, cimetidine or erythromycin).
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CF01 - zopiclone ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Presentation/Packing
Form
Apo-Zopiclone tab 7.5 mg
Packing/Price
100's
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