INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo 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 as an oral rinse, 3 hourly. Do not swallow.
As a Spray:
5-10 sprays directly onto the painful or inflamed area. Repeat every 1½ to 3 hours as required. Contact with the eyes should be avoided.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Gastro-intestinal disorders:
Have been reported (frequency unknown): Oral numbness, a burning or stinging sensation has also been reported. Dry mouth, thirst, gastro-intestinal disturbances, nausea, vomiting, tingling and a warm feeling in the mouth are other local adverse effects that may occur. An altered sense of taste may also occur. Prolonged use may result in reversible discolouration of the teeth or tongue and silicate or composite restorations.

SPECIAL PRECAUTIONS:
Do not use continuously for more than 7 days except under medical supervision. Allow at least 30 minutes between the use of toothpaste and ANDOSEPT-CO.
Contact with the eyes should be avoided.
The main consequence of ingestion is mucosal irritation but systemic toxicity is rare.
Adverse central nervous system effects have been known to occur following overdosage with high doses of ANDOSEPT-CO.
As there is no specific antidote for benzydamine, treatment should be symptomatic and supportive.
Refer to "SIDE-EFFECTS AND SPECIAL PRECAUTIONS" for further information.

IDENTIFICATION:
A bright, clear, pale pink solution with a slightly fruity, thymol odour and flavour and a bitter aftertaste.

PRESENTATION:
Round, 200 mL clear PET bottle with a tamper evident screw cap.

STORAGE INSTRUCTIONS:
Store below 25ºG.
Store in the carton to protect from light.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER:
A41/16.5/0190

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF PACKAGE INSERT:
4 December 2006

575233

New addition to this site: June 2008
Source: Pharmaceutical Industry

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