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

Logo OROSEPT (mouthwash)

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

OROSEPT (mouthwash)

COMPOSITION:
Each 100 mL of solution contains:
  Chlorhexidine gluconate solution 20% 1 mL
  Alcohol 96% (as preservative) 20% v/v
PHARMACOLOGICAL CLASSIFICATION:
A.16.4 Naso-pharyngeal and bucco-pharyngeal antiseptics.

PHARMACOLOGICAL ACTION:
Chlorhexidine is a bactericidal cationic antiseptic. It acts by destroying the cell membrane and precipitating the cell cytoplasm. It has been shown that chlorhexidine binds on to the hydroxyapatite of tooth enamel, onto the pellicle of the tooth surface and on to salivary mucins. It slowly desorbs from these sites to exert a prolonged bactericidal effect for several hours.

INDICATIONS:
OROSEPT mouthwash is an antibacterial solution which inhibits the formation of dental plaque. It is indicated as an aid in the treatment and prevention of gingivitis, and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (e.g. following periodontal and other oral surgery or in mentally or physically handicapped patients).

CONTRA-INDICATIONS:
OROSEPT is contra-indicated in patients hypersensitive to chlorhexidine.

DOSAGE AND DIRECTIONS FOR USE:
Use 10 mL (2 medicine measuresful) undiluted, or diluted with a small quantity of warm water and thoroughly rinse the mouth for about one minute twice daily. For the treatment of gingivitis, a course of about one month is advisable, although some variation in response is to be expected. In oral candidal infections, treatment should be continued for 48 hours after clinical resolution. For the treatment of denture stomatitis, the dentures should be cleansed and soaked in the solution for 15 minutes twice daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local skin sensitivity reactions may occur. Prolonged use may cause discolouration of the teeth.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic effects such as acute alcohol poisoning due to ingestion should be treated by gastric lavage. Further treatment is supportive and symptomatic.

IDENTIFICATION:
Clear, orange red viscous liquid.

PRESENTATION:
Amber glass bottles: 100 mL.

STORAGE INSTRUCTIONS:
Store in a cool place below 25° C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
R/16.4/220

NAME AND BUSINESS ADDRESS OF APPLICANT:
Triomed (Pty) Limited
Building No. 3
Parc Du Cap
Corner Mispel Road and Willie van Schoor Road
BELVILLE
7530.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23.01.1989

        M985

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