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

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

NOCTAMID TABLETS

Hypnotic

COMPOSITION
1 Noctamid tablet contains lormetazepam (7-chloro-5-(2-chlorophenyl)-3-hydroxy-1-methyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one) 1,0 mg.

PHARMACOLOGICAL CLASSIFICATION
A. 2.2 Hypnotic.

PHARMACOLOGICAL ACTION
Lormetazepam has sedative, hypnotic properties.

INDICATIONS
Difficulty in falling asleep; disturbed sleep.
Noctamid is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.

CONTRA-INDICATIONS
Noctamid may not be used in pathologically increased fatigability of certain groups of muscles (myasthenia gravis) and in narrow-angle glaucoma. Noctamid should not be used during pregnancy or lactation.

DOSAGE AND DIRECTIONS FOR USE
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
Unless otherwise directed, adults take 1 tablet Noctamid (1 mg) as a single dose. Elderly and debilitated patients take half a tablet (0,5 mg). It is possible to double the dose in individual cases.
The tablets are taken with a little liquid shortly before going to bed.
After daily long-term use (more than 2 weeks) Noctamid should not be withdrawn suddenly, since sleep disturbances may then recur temporarily in a heightened form. It is therefore advisable to conclude the treatment by reducing the dose step by step.
Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks, with a maximum, including tapering off process, of four weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Noctamid is not recommended for the primary treatment of psychotic illness. Noctamid should not be used alone to treat depression or anxiety with depression (suicide may be precipitated in such patients). Noctamid should be used with extreme caution in patients with a history of alcohol or drug abuse.
Headaches, sleepiness, drowsiness, dizziness and unsteady movements can occur on the following day in particularly sensitive persons such as debilitated patients and elderly persons, and after ingestion of an excessive dose. Less commonly depression of mood and affect, disorientation or confusion and lethargy may be produced. A reciprocal intensification of effects is to be expected if Noctamid is taken with centrally depressing drugs and/or alcohol.
Dependence
There is a potential for abuse and the development of physical and psychic dependence, especially with prolonged use and high doses. The risk of dependence is also greater in patients with a history of alcohol or drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound effects
The transient syndrome whereby the symptoms that led to treatment with Noctamid recur in an enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment it is recommended that the dosage is decreased gradually.
Reactions (active participation in road traffic, machine operation), can be impaired depending on the time of ingestion, the individual sensitivity and dosage.
Depressive patients might, as with other hypnotics with this type of action, experience aggravation of their symptoms.
Paradoxical reactions such as acute hyperexcitable states with rage may occur. If these occur, Noctamid should be discontinued.
Given during labour Noctamid crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking.
Particular caution should be exercised in the following instances:

•	elderly and debilitated patients - 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 should be cautioned regarding the additive effect of alcohol.

Duration of treatment
The duration of treatment should be as short as possible (see “Dosage and directions for use”), but should not exceed 4 weeks of insomnia, including tapering off process. Extension beyond these periods should not take place without reevaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms, should they occur while the product is being discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of overdosage are respiratory and cardiovascular depression, hypotension, drowsiness, ataxia and slurred speech. Treatment is symptomatic. Gastric lavage may be useful if performed soon after ingestion.

IDENTIFICATION
Round, white, flat-sided tablets with bevelled edges. Upper side: impressed with CF in an equilateral hexagon. Lower side: scored.

PRESENTATION
Packs containing 30 tablets.

STORAGE INSTRUCTIONS
Store below 30°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER
P/2.2/16

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
10 November 1981

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry
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