INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ANDOSEPT-CO (oral rinse)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ANDOSEPT-CO (oral rinse)

COMPOSITION:
Each 15 mL contains 22,5 mg of BenzydamineHydrochloride
18 mg of ChlorhexidineGluconate
9% v/v Alcohol (contains no sugar)

PHARMACOLOGICAL CLASSIFICATION:
Category A.16.5 Ear, nose and throat preparations.

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.
Chlorhexidine gluconate is an antiseptic and a disinfectant.
It is bactericidal or bacteriostatic against a wide range of Gram-positive and Gram-negative bacteria.
The Chlorhexidine gluconate is absorbed onto the cell walls of micro-organisms, and causes leakage of the intracellular components.
Pharmacokinetics:
Approximately 30% of chlorhexidine gluconate is retained in the oral cavity following rinsing. It is subsequently released slowly into the oral fluids. Chlorhexidine is poorly absorbed from both the gastrointestinal tract and skin.

INDICATIONS:
ANDOSEPT-CO can be used for the relief of minor infections as well as painful inflammatory conditions of the mouth and throat.
Chlorhexidine can be used for the reduction of dental plaque.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients in the formulation.
ANDOSEPT-CO should not be used in children under 6 years of age.
The safety in pregnancy and lactation has not been established.

WARNINGS:
ANDOSEPT-CO should not be used uninterrupted for longer than 7 days except under medical supervision.

INTERACTIONS:
Toothpastes may contain anionic surfactants (e.g. sodium laurylsulphate), which are incompatible with chlorhexidine.
(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-CO is generally used undiluted, but the solution can be diluted with water should stinging occur.
Children (6 to 12 years):
Use 5 mL to 15 mL (one to three medicine measures) as a gargle if they are able to do so, otherwise use a