Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ANDOSEPT (oral rinse) SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): ANDOSEPT (oral rinse) COMPOSITION: Each 15 mL contains 22,5 mg of Benzydamine Hydrochloride. Alcohol 9.98% v/v Contains Tartrazine Preservatives: Sodium methyl parahydroxybenzoate 0.180% m/v Sodium propyl parahydroxybenzoate 0.020% m/v PHARMACOLOGICAL CLASSIFICATION Category A.16.5 Ear, nose and throat preparations - other. PHARMACOLOGICAL ACTION Benzydamine hydrochloride has local analgesic and anti-inflammatory properties. Benzydamine hydrochloride exerts this action by stabilizing the cell membrane and inhibiting the synthesis of prostaglandins. INDICATIONS ANDOSEPT can be used for the relief of minor infections as well as painful inflammatory conditions of the mouth and throat. CONTRA-INDICATIONS Hypersensitivity to any of the ingredients in the formulation. ANDOSEPT should not be used in children under 6 years of age. The safety in pregnancy and lactation has not been established. WARNINGS ANDOSEPT should not be used uninterrupted for longer than 7 days except under medical supervision. INTERACTIONS (See “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”). PREGNANCY AND LACTATION The safety of this formulation in pregnancy and lactation has not been established. DOSAGE AND DIRECTIONS FOR USE For use as a gargle: Gargle with 15 mL (approximately one tablespoon) for at least 30 seconds. Repeat at 1½ to 3 hourly intervals, as required. Do not swallow. For use as a rinse for oral lesions: Rinse with 15 mL (approximately one tablespoon). Hold the solution in the mouth and swirl around for at least 30 seconds. Repeat at 1½ to 3 hourly intervals throughout the day as required. Do not swallow. ANDOSEPT is generally used undiluted, but the solution can be diluted with water should stinging o Read the complete document