Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
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 After daily long-term use (more than 2 weeks) Noctamid should not be withdrawn suddenly, since sleep disturbances may then recur temporarily in a heightened form.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 recomm Read the complete document