Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Lennon
INDICATIONS [/za_1305.html#1] [/za_1305.html#1] [/za_1305.html#1] CONTRA-INDICATIONS [/za_1305.html#1] [/za_1305.html#1] DOSAGE [/za_1305.html#1] [/za_1305.html#1] SIDE-EFFECTS [/za_1305.html#1] [/za_1305.html#1] [/za_1305.html#1] PREGNANCY [/za_1305.html#1] [/za_1305.html#1] OVERDOSE [/za_1305.html#1] IDENTIFICATION [/za_1305.html#1] [/za_1305.html#1] PATIENT INFORMATION INSOM TABLETS SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): INSOM TABLETS COMPOSITION: Each tablet contains 2 mg FLUNITRAZEPAM . PHARMACOLOGICAL CLASSIFICATION: A 2.2 Sedatives and hypnotics PHARMACOLOGICAL ACTION: Flunitrazepam is a benzodiazepine which has anxiolytic, sedative, muscle relaxant and anticonvulsant properties. INDICATIONS: Flunitrazepam is indicated for the short-term treatment of insomnia. CONTRA-INDICATIONS: Insom is contra-indicated in children, pregnancy and lactation. Patients with a known sensitivity to Flunitrazepam or other benzodiazepines. Pre-existing central nervous system depression or coma. Psychotic patients, and those suffering from mental depression or suicidal tendencies, unless there is a marked component of anxiety in their illness. Patients with acute closed-angle glaucoma and myasthenia. Severe chronic hypercapnia. Acute porphyria. WARNINGS: KEEP OUT OF REACH OF CHILDREN. There is potential for abuse. Prolonged use may lead to the development of dependence of the barbiturate-alcohol type. The withdrawal of Flunitrazepam should be gradual after long-term use. Even after short-term use, a tapering-off regime is recommended. Insom may enhance the effects of other central nervous system depressants. Insom causes drowsiness and sedation. Patients should be warned not to drive motor vehicles, operate machinery or climb dangerous heights, until the individual effect on th Les hele dokumentet