BETADINE VAGINAL 200mg Milligram Pessary

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

POVIDONE-IODINE

Beschikbaar vanaf:

Seton Healthcare Group PLC

INN (Algemene Internationale Benaming):

POVIDONE-IODINE

Dosering:

200mg Milligram

farmaceutische vorm:

Pessary

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-07-07

Productkenmerken

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Vaginal Pessaries.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine 200mg
For excipients see section 6.1
3 PHARMACEUTICAL FORM
Pessary
Smooth dark-brown in colour and tapered.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
As an antiseptic in the management of vaginitis due to
organisms sensitive to iodine and in pre-operative vaginal 
preparation
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For intravaginal administration.
Using the applicator, insert a pessary morning and night for up
to 14 days. Each pessary should be wetted with water 
immediately prior to insertion, thus ensuring maximum dispersion
of the active constituent and avoiding risk of local 
irritation.
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 SPECIAL 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
 with pre-existing renal insufficiency.
4. 
Regular use should be avoided in patients on
concurrent lithium therapy.
IRISH MEDICINES BOARD
____________________________________________________________________________________________________________________