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

Logo ORMODON TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ORMODON TABLETS

COMPOSITION:
Each tablet contains 5 mg
Nitrazepam

PHARMACOLOGICAL CLASSIFICATION:
2.2 Sedatives, hypnotics

PHARMACOLOGICAL ACTION:
Nitrazepam is a hypnotic of the benzodiazepine group which acts in 30 to 60 minutes to produce sleep lasting for 6 to 8 hours. It has a half-life of 21-25 hours.

INDICATIONS:
Relief of insomnia.

CONTRA-INDICATIONS:
Apart from the rare cases of myasthenia gravis in which the additional muscle-relaxing effect of Ormodon could have deleterious consequences, there are no known contra-indications for Ormodon.

WARNINGS
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
The usual adult dose is 5 - 10 mg at bedtime
The initial dose should be reduced in elderly and debilitated patients.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
With Ormodon, as with other hypnotics, patients should avoid taking alcohol while under the influence of treatment, since the individual response cannot be foreseen. Like all medicaments of this type, Ormodon may modify the patient's reactions (driving ability, behaviour in traffic etc.) to a varying extent, depending on dosage, administration and individual susceptibility. In elderly patients with cerebrosclerosis or cardio-respiratory insufficiency, dosage of Ormodon should be adjusted with particular caution to individual tolerance.
Ormodon should be used with caution in patients taking monoamine oxidase inhibitors or phenothiazines.
The established medical principle of prescribing medicaments in early pregnancy only when absolutely indicated should be observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
Treatment: Gastric lavage can be performed up to 2 hours after ingestion. In case of marked sedation, analeptics, e.g. caffeine or Nikethamide can be given.

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

IDENTIFICATION:
White tablet with score mark. Diameter 12,5 mm.

PRESENTATION:
Containers of 20

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.

REGISTRATION NUMBER:
K/2.2/140

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Ormed Limited, Howard Studios, Howard Drive
Pinelands 7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1/11/86

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