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

Logo BETADINE* DOUCHE

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BETADINE* DOUCHE

COMPOSITION:
Each 1 mL contains
povidone-iodine 100 mg, equivalent to 10 mg available iodine.

PHARMACOLOGICAL CLASSIFICATION:
A 18.6 Vaginal Preparations

PHARMACOLOGICAL ACTION:
Povidone-iodine is a multivalent broad spectrum local antiseptic having bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Many viruses, protozoa, yeasts, cysts and spores are also susceptible.

INDICATIONS:
1. Trichomonal, monilial, bacterial and non-specific vaginitis.
2. Cleansing and deodorising douche.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. Patients with non-toxic nodular colloid goitre should not use povidone-iodine. This product is spermicidal and should not be used when conception is desired.

WARNINGS:
1. Not to be used by persons who are allergic to iodine.
2. Not to be used in pregnancy or by lactating women.

DOSAGE AND DIRECTIONS FOR USE:
As a Therapeutic Douche - Add two medicine measurefuls (10 mL) of BETADINE* DOUCHE to the anatomically shaped applicator bottle (340 mL) and fill it with lukewarm water to the indicated filling line. Use once per day for 7-14 days, or as directed by the physician.

As a Cleansing and Deodorising Douche - Add one medicine measureful (5 mL) of BETADINE* DOUCHE to the anatomically shaped applicator bottle (340 mL) and fill it with lukewarm water to the indicated filling line. Use once or twice weekly, or as directed by the physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Povidone-iodine sensitivity may develop in certain individuals. If irritation, discomfort, redness, swelling or other signs of sensitivity occur, the patient should discontinue use and consult her physician. Alkalis will reduce the activity of this preparation. Absorption of povidone-iodine may interfere with thyroid function tests. This product is spermicidal and should not be used when conception is desired.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic effects include metabolic acidosis, hypernatraemia and renal impairment. Treatment is symptomatic and supportive.

IDENTIFICATION:
BETADINE* DOUCHE
is a dark brown, pleasantly perfumed aqueous liquid.

PRESENTATION:
Plastic printed bottle of 250 mL (the actual container that holds the undiluted douche), and an unprinted douche bottle (used for diluting, mixing and application of the douche) as well as a nozzle and plastic measuring cup.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
C/18.6/143

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
Bryanston 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 September 1993

Under licence from :
Mundipharma AG; Switzerland

* BETADINE is a Registered Trade Mark

New addition to this site: April 2004
Source: Pharmaceutical Industry

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