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Nitrazepam Tablets
 Active Ingredients:
Each tablet contains 10 mg Nitrazepam
COMPOSITION
Each tablet contains 10 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.
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