Betadine VC Kit 10% w/v.

Povidone Iodine USP 10% w/v.

Solution.

As a vaginal cleanser in the treatment of vaginitis due to candidal, trichomonal, non-specific or mixed infections and for pre-operative preparation of the vagina.

For intravaginal use. Adults and the elderly: Once a day (preferably in the morning) for a 14 day period, including days of menstruation. The Betadine VC Concentrate should be diluted 1:10 using the measuring cap, and used according to the patient instruction leaflet provided. The applicators should only be used for the administration of the diluted VC Kit solution. This product may be used in combination with Betadine Vaginal Pessaries. Children: Contra-indicated for use in pre-pubertal children.

Known or suspected iodine hypersensitivity. Regular use is contra-indicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

Absorption of iodine from povidone iodine through either intact or broken skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.

None known.

If local irritation, redness or swelling develops, discontinue treatment. Iodine is absorbed from the vagina and following prolonged use, thyroid dysfunction may develop. The product may be spermicidal and should not be used when conception is desired.

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

Povidone iodine is a complex of iodine which retains the broad spectrum germicidal activity of elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

Betadine VC Concentrate is applied topically to the affected area.

None stated.

Nonoxynol 9; Fleuroma Bouquet 477; purified water.

Compatibility with barrier contraceptives has not been established. Therefore this product should not be used with such methods of contraception as their reliability may be affected.

36 months.

Store at or below 25^oC.

Carton containing a white polypropylene container with a white polypropylene wadless cap containing 250ml Betadine VC Concentrate, an empty turquoise low density polypropylene squeeze bottle and a vaginal applicator.

None stated.

Seton Healthcare Group plc, Tubiton House, Oldham, OL1 3HS.

PL 0223/0020.

28^th April 1993 / 17^th November 1998.

April 2003.