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

Logo 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 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 of 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. 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 discoloration 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.
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.
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, green solution with a spearmint odour and flavour.

PRESENTATION
ANDOSEPT will be packed in the following containers:
200 mL, round clear glass bottle with a white plastic tamper evident screw cap, packed in a printed cardboard unit carton or
200 mL, clear plastic bottle with a white plastic tamper evident screw cap, packed in a printed cardboard unit carton.

STORAGE INSTRUCTIONS
Store below 25ºC. Protect from light. Keep bottles well-closed.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER
A40/16.5/00718

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Pharmacare Limited
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2191

DATE OF PUBLICATION OF PACKAGE INSERT
3 October 2007

Updated on this site: July 2009
Source: Pharmaceutical Industry

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