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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Vaginal Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine 10 % w/w.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
Dark red-brown in colour with a smooth consistency.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for use in the management of vaginitis due to organisms sensitive to iodine and in pre-operative
vaginal preparation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravaginal administration.
One applicator full nightly.
Remove cap from tube and screw tube into threaded open end of applicator. Pull plunger back to limit. Fill applicator
with vaginal gel and detach from tube. In a reclining position, gently insert applicator high in vagina and depress
plunger to deposit vaginal gel.
Insert an applicator full of gel (5g) every night for up to 14 days. If menstruation occurs during treatment it is important
to continue treatment during the days of the period.
4.3 CONTRAINDICATIONS
1. Known or suspected iodine hypersensitivity.
2. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre,
endemic goitre and Hashimoto’s thyroiditis).
3. Use in pre-pubertal children.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1. 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.
2. If no improvement occurs the doctor should be consulted.
3. Special caution is needed when regular applications to inflamed or broken vaginal mucosa are made to patients
IRISH MEDICINES BOARD
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