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

Logo NORMISON® 10 mg Capsules
NORMISON® 20 mg Capsules

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

NORMISON® 10 mg Capsules
NORMISON® 20 mg Capsules

COMPOSITION:
Chemically temazepam is known as
7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one.
Capsules contain 10 mg or 20 mg
temazepam.
PRESERVATIVES:
Ethyl sodium parahydroxybenzoate         0,29% m/m
Propyl sodium parahydroxybenzaoate         0,15% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.2 Sedative, hypnotic.

PHARMACOLOGICAL ACTION:
The exact mechanism of action of benzodiazepines has not yet been elucidated., however, benzodiazepines appear to work through several mechanisms. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system either by potentiating the effects of synaptic or presynaptic inhibition mediated by gamma-aminobutyric acid or by directly affecting the action potential generating mechanisms.
Mean serum elimination half-life after single evening administration is approximately 8,3 hours. In studies where NORMISON (temazepam) was given in the morning, the half-life usually ranged from 5 - 15 hours. Peak plasma levels of temazepam occur 1,25 - 1,5 hours after administration when given orally. With multiple dosing steady state is obtained by the third day, and there is little or no accumulation of parent drug or metabolites.
NORMISON (temazepam) is metabolised principally in the liver where most of the unchanged temazepam is directly conjugated to the glucuronide and excreted in the urine. Some temazepam is demethylated to oxazepam and eliminated as the glucuronide. The glucuronides of NORMISON (temazepam) have no demonstrable central nervous system activity. Following a single dose, 80% of the dose appears in the urine, mostly as the conjugates, and 12% of the dose appears in the faeces. Less than 2% of the dose is excreted unchanged in the urine. Approximately 96% of unchanged temazepam is bound to plasma proteins.

INDICATIONS:
1. NORMISON (temazepam) is indicated for use as a hypnotic or night-time sedative in adults. The prolonged administration of NORMISON (temazepam) is not recommended.
2. NORMISON (temazepam) is indicated for the use as a premedicant taken 30 - 60 minutes prior to surgical or other procedures.

CONTRA-INDICATIONS:
Idiosyncrasy to benzodiazepine derivatives. Insomnia due to depression.

WARNINGS:
Patients receiving NORMISON (temazepam) should be warned not to operate dangerous machinery or motor vehicles or climb dangerous heights until they know that they do not become drowsy or dizzy from temazepam therapy.
Patients should be advised that their tolerance for alcohol and other central nervous system depressants will be diminished and these substances should either be eliminated or given in reduced dosage in the presence of temazepam.
Withdrawal from the medication should be gradual. As with other sedative-hypnotics when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after long term daily use of temazepam.
It is recommended that the need for continued therapy of NORMISON (temazepam) be determined periodically.

DOSAGE AND DIRECTIONS FOR USE:
The recommended adult dose in 10 mg to 30 mg thirty minutes before retiring.
For use as a premedicant, the recommended adult dose is 20 mg to 30 mg thirty to sixty minutes prior to surgical or other procedures.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS
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 affect, disorientation or confusion, lethargy and ataxia.
Morning headaches, transient rashes and gastro-intestinal disturbances have been reported.
Paradoxical reactions such as acute hyperexcitable states with rage may occur. If these occur temazepam should be discontinued.
Transient amnesia or memory impairment may occur.

SPECIAL PRECAUTIONS:
1. Patients should be cautioned against driving or operating machinery, or climbing dangerous heights. While taking temazepam judgement on critical decisions may be impaired.
2. Patients taking NORMISON (temazepam) should be warned that their tolerance to alcohol or other central nervous system depressants may be lowered. If temazepam is to be combined with other central nervous system - active agents, careful consideration should be given to the pharmacology of the agents employed. Caution should be exercised against the possibility of dependence.
3. Particular caution should be exercised with the elderly and debilitated who are at particular risk of oversedation, respiratory depression and ataxia. (The initial oral dose should be reduced in these patients).
4. Patients with pulmonary disease and limited pulmonary reserve should be treated with caution.
5. Caution should be exercised in treating patients suffering from anxiety accompanied by an underlying depressive disorder.
6. Elderly patients, or those suffering from cerebral vascular changes, such as arteriosclerosis are likely to respond to smaller doses.
7. NORMISON (temazepam) should not be used for extended periods.
8. Some patients on temazepam have developed blood dyscrasias, and some have had elevations in liver enzymes. Periodic blood counts and liver function tests are recommended.
9. Given prior to or during labour benzodiazepines cross the placenta and may cause the floppy infant syndrome characterised by central respiratory depression, hypothermia and poor sucking.
10. It is not known whether temazepam is excreted in human milk. Caution should be exercised when temazepam is given to a nursing woman since there is evidence that benzodiazepines are excreted in human breast milk.
11. Caution should be exercised in the treatment of patients with acute narrow-angle glaucoma.
12. The usual precautions for treating patients with impaired renal or hepatic function should be observed.
13. The safety and effectiveness of temazepam has not been established in children less than 16 years of age.
Use during pregnancy:
Safety in pregnancy has not been established.
Abuse and Dependence:
Abuse:
There is a potential for abuse.
Addiction-prone individuals such as drug addicts and alcoholics, should be under careful surveillance when receiving NORMISON (temazepam) because of the predisposition of such patients to habituation and dependence.
Dependence:
The use of benzodiazepines may lead to dependence. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of benzodiazepine drugs. These symptoms can range from mild dysphoria and insomnia to a major syndrome which may include convulsions, tremor, abdominal and muscle cramps, vomiting and sweating. These symptoms, especially the more serious ones, are more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels. Accordingly, temazepam should be terminated gradually to help avoid occurrence of withdrawal symptoms.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
Induce vomiting and/or gastric lavage should be undertaken followed by general supportive care. The value of dialysis has not been determined for temazepam.
Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy.
In more serious cases, symptoms may include ataxia, hypotonia, hypotension, hypnosis, stages one (1) to three (3) coma, and very rarely death.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
The NORMISON 10 mg capsule is a clear, colourless, oval soft gelatine capsule, containing a clear colourless liquid gel, –10,9 mm in length.
The NORMISON 20 mg capsule is a clear, colourless, oval soft gelatine capsule, containing a clear colourless liquid gel, –14,85 mm in length.

PRESENTATION:
NORMISON 10 mg capsules are supplied in bottles of 60 and 250 capsules.
NORMISON 20 mg capsules are supplied in amber glass bottles of 30 and 100 capsules and amber glass vials of 4 capsules.

STORAGE DIRECTIONS:
Store in a cool (below 25°C), dry place. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
NORMISON 10 mg capsule: L/2.2/125
NORMISON 20 mg capsule: M/2.2/205

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
Building 12, Healthcare Park, Woodlands Drive, Woodmead, Sandton 2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 DECEMBER 1989

® REGISTERED TRADE MARK

Product and trademark under licence of WYETH-AYERST LABORATORIES. U.S.A.

308431        030708        Harry's Printers -K30354 G03

Updated on this site: October 2004
Source: Community Pharmacy

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