Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Medlock Medical Ltd
10 %w/v
Vaginal Gel
2005-02-11
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 ___________________________________ Read the complete document