Source: Health Products Regulatory Authority (ZA) Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530
ZOPIVANE is indicated for the short-term treatment of insomnia in adults.
7,5 mg (one tablet) taken orally shortly before retiring at night. This dose should not be exceeded.
Treatment should be started with the lowest recommended dose and the maximum dose should not be exceeded.
3,75 mg taken orally shortly before retiring at night, initially. This may be increased to 7,5 mg depending on the effectiveness and tolerance of the tablets.
Although accumulation of zopiclone has not been observed in patients with renal insufficiency, it is recommended that treatment should be initiated with 3,75 mg.
ZOPIVANE should not be prescribed to children younger than 18 years old.
Overdosage usually presents with varying degrees of central nervous system depression, ranging from drowsiness to coma, according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia; hypotension, respiratory depression and coma. When the overdosage is combined with alcohol or other CNS depressants, it may be life-threatening. Other risk factors such as the presence of concomitant illness and the debilitated state of the patient may contribute to the severity of the symptoms and can result in fatal outcome.
Symptomatic and supportive treatment in an adequate clinical environment, is recommended, with special attention to respiratory and cardiovascular functions. Gastric lavage is of value only if performed soon after ingestion. Flumazenil may be useful as an antidote. Haemodialysis is of no value due to the large volume of distribution of ZOPIVANE.
24 months.
Store in a cool, dry place at or below 25°C. Protect from light.
ZOPIVANE tablets are supplied in blister strips of 10 tablets, packed in 30’s in a carton.
No special requirements.
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