INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DORMÉ 15 mg tablets
SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

DORMÉ 15 mg tablets

COMPOSITION
Per tablet:
Quazepam         15 mg

PHARMACOLOGICAL CLASSIFICATION
A 2.2 Sedatives, hypnotics

PHARMACOLOGICAL ACTION
DORMÉ (quazepam) is a benzodiazepine-type hypnotic. In vitro, quazepam binds relatively selectively to benzodiazepine-1 receptors.

INDICATIONS
Short-term treatment of insomnia

CONTRA-INDICATIONS
Quazepam is contra-indicated in patients with a known sensitivity to the active or other benzodiazepines; in patients with an established or suspected sleep apnoea and in patients with narrow angle glaucoma.

DOSAGE AND DIRECTIONS FOR USE
DOSAGE SHOULD BE INDIVIDUALISED ACCORDING TO THE SEVERITY OF SYMPTOMS AND THE RESPONSE OF THE PATIENT.
Adults: One tablet on retiring is generally adequate. In more severe cases and in acute insomnia two tablets can be administered.
Elderly or debilitated patients: Initial dose of one tablet at bedtime until individual responses are determined. In some cases half a tablet may be the desired dose.
THE RESPONSE OF THE PATIENT TO SEVERAL DAYS TREATMENT WILL PERMIT THE PHYSICIAN TO ADJUST THE DOSE UPWARD OR DOWNWARD.
Hospitalised patients scheduled for surgery: Two tablets at bedtime.

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. Less common are depression of mood, disorientation or confusion, lethargy, and ataxia.
Paradoxical reactions such as acute hyperexcitable states with rage may occur. If these occur, the medicine should be discontinued.
There is a potential for abuse. Withdrawal symptoms (including convulsions) have occurred following abrupt cessation, especially in patients receiving large doses for prolonged periods.
Special precautions:
Long-term safety in humans has not been established. Prolonged administration ie not advisable, since insomnia is often transient and intermittent and appropriate patient evaluation may be required with careful consideration of different forms of treatment in addition to treatment of the underlying disorder.

Particular caution should be exercised with the elderly and debilitated - who are at particular risk of oversedation, respiratory depression and ataxia (the initial oral dosage should be reduced in these patients); patients with pulmonary disease and limited pulmonary reserve; patients suffering from impairment of renal or hepatic function; patients suffering from anxiety accompanied by an underlying depressive disorder; patients receiving barbiturates or other central nervous system depressants. There is a synergistic risk of central nervous system depression when these medicines are taken together; patients should be cautioned regarding the additive effect of alcohol.

Pregnancy and lactation: the medicine should be used judiciously during pregnancy and preferably avoided. 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.

Note: Patients should be advised, particularly at the initiation of therapy, not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery. In these situations, impaired decision-making could lead to accidents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT :
See side-effects.
Treatment is symptomatic and supportive.

IDENTIFICATION
Round, white to off-white, biconvex tablet, scored on one side

PRESENTATION:
Tablets: 30' in blister packs

STORAGE INSTRUCTIONS
Store below 30°C. Protect from excessive moisture and from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
Q/2.2/188

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
17 March 1993

NORISTAN LABORATORIES
Division of
NORISTAN LIMITED, WALTLOO PRETORIA
Under licence to Baker Cummins Pharmaceuticals Incorporated Miami, Florida, USA

D 294/01

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