Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Schering
COLOFAC 135 mg TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): COLOFAC 135 mg TABLETS COMPOSITION 1 tablet contains mebeverine HCl (veratric acid, 4-[ethyl(p-methoxy-alpha-methylphenethyl)amino] butyl ester hydrochloride), 135 mg. PHARMACOLOGICAL CLASSIFICATION A. 11.2 Gastro-intestinal anti-spasmodics and cholinolytics. PHARMACOLOGICAL ACTION Colofac 135 mg is a musculotropic spasmolytic agent with a selective action, especially on smooth muscle spasms of the gastro-intestinal tract. In vivo studies showed Colofac 135 mg to have spasmolytic properties, especially on the sphincter of Oddi (20-40 times greater than with papaverine), on the cardia and on the ileum. Little or no antispasmodic effect was seen on the uterus and the bronchial muscles. Gastric emptying time and intestinal propulsion were affected much less than by papaverine. No significant inhibition of normal peristalsis has been observed. INDICATIONS Primary irritable colon characterised by persistent diarrhoea, alternating constipation and diarrhoea, abdominal pain and postprandial distension. Secondary irritable colon due to organic lesions such as regional enteritis, diverticulitis, specific and non-specific inflammatory conditions of the gastro-intestinal tract. CONTRA-INDICATIONS Hypersensitivity to any ingredient in the product. DOSAGE AND DIRECTIONS FOR USE 135 mg mebeverine hydrochloride (1 tablet) 3 times daily, preferably before meals. After a period of a few weeks when the desired effect has been obtained, the dosage may be gradually reduced. As atropine-like effects are absent, Colofac 135 mg is not contra-indicated in patients with glaucoma or prostatic hypertrophy. SIDE-EFFECTS AND SPECIAL PRECAUTIONS After the administration of Colofac 135 mg cases of depression, headache, dizziness, diarrhoea and constipa Lugege kogu dokumenti