(and dosage form):
Each capsule contains 5 mg Nitrazepam
A 2.2 Sedatives, hypnotics
Nitrazepam is a hypnotic of the benzodiazepine group which acts in 30 to 60 minutes to produce sleep lasting for 6 to 8 hours. Plasma concentration declines with a half-life of 21 - 25 hours.
Nitrazepam is contra-indicated in patients with a known hypersensitivity towards it.
DOSAGE AND DIRECTIONS FOR USE:
The usual dose is 5 - 10 mg taken at bedtime but it may be increased to 10 mg if necessary.
For the elderly, 5 mg is usually adequate.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects most commonly encountered are drowsiness and oversedation. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses. Depression of mood and effect, disorientation and confusion, lethargy and ataxia may also occur.
Paradoxical reactions such as acute hyperexcitability states with rage may occur. If these occur, the medicine should be discontinued.
There is potential for abuse. Withdrawal symptoms (including convulsions) have occurred following abrupt cessation, especially in patients receiving large doses for prolonged periods. Nightmares may occur in the elderly.
Particular caution should be exercised with the elderly and debilitated who are at particular risk of oversedation, respiratory depression and ataxia. In these patients the initial oral dose should be reduced.
Nitrazepam should be used with caution in patients with pulmonary disease and limited pulmonary reserve, in patients suffering from impairment of renal or hepatic function and in patients suffering from anxiety accompanied by an underlying depressive disorder.
Caution should be exercised when nitrazepam is used for patients receiving barbiturates or other central nervous system depressants as there is an additive risk of central nervous system depression when these medicines are taken together. Patients should be cautioned regarding the additive effect of alcohol.
Nitrazepam should be used judiciously during pregnancy and preferably avoided. When given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking. It should not be administered to lactating mothers.
Patients should be advised, particularly at the initiation of therapy, not to drive a motor-vehicle, climb dangerous heights or operate dangerous machinery. In those situations, impaired decision making could lead to accidents.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
The stomach should be emptied by aspiration and lavage.
Treatment should be supportive and symptomatic.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
Purple and yellow capsules.
Containers of 30, 200 and 1000 capsules.
Store in a well-closed container and protect from light and moisture. Store in a cool place (below 25°C).
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABS. LIMITED
1 Manchester Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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