Betadine Vaginal Douche 10% w/v

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

POVIDONE, IODINE

Available from:

Mundipharma Pharmaceuticals Limited 13 Othellos Street, Dhali Industrial Zone, Nicosia, Cyprus

ATC code:

G01AX11

INN (International Name):

POVIDONE-IODINE 10 % (W/V)

Pharmaceutical form:

VAGINAL SOLUTION

Composition:

POVIDONE-IODINE 10 % (W/V)

Prescription type:

OTC

Therapeutic area:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Authorization status:

Authorised

Authorization date:

2006-05-26

Patient Information leaflet

PILBVDMT01v2.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE
® VAGINAL DOUCHE 10%W/V
Povidone-Iodine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BETADINE
® VAGINAL DOUCHE is and what it is used for
2.
What you need to know before you use BETADINE
® VAGINAL DOUCHE
3.
How to use BETADINE
® VAGINAL DOUCHE
4.
Possible side effects
5.
How to store BETADINE
® VAGINAL DOUCHE
6.
Contents of the pack and other information
1.
WHAT BETADINE
® VAGINAL DOUCHE IS AND WHAT IT IS USED FOR
BETADINE
® VAGINAL DOUCHE is an antiseptic containing Povidone-Iodine, which is
broad-
spectrum germicide (destructive to germs). It is effective for all
vaginal infection. It offers rapid
relief of symptoms such as burning or irritation.
It is used as a vaginal cleanser for the treatment of vaginitis
(inflammation of the vagina) due
to candidal, trichomonal, non-specific or mixed infections and for
preoperative disinfection of
the vagina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETADINE
® VAGINAL DOUCHE
-
If you are allergic to Povidone-Iodine or any of the other excipients
of this medicine (listed
in section 6).
-
In patients hypersensitive to iodine or any other of the excipients
listed in section 6.
-
In patients with thyroid disorders (in particular nodular colloid
goiter, endemic goiter and
Hashimoto’s thyroiditis).
-
In patients taking lithium.
-
In pre-pubertal children.
-
before, during and after radio-iodine administration.
-
in patients using products containing mercury.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using BETADINE
® VAGINAL DOUCHE
-
Special caution is needed when regular applications to

Summary of Product characteristics

Page 1 of 5
SPCBVDMT01v2.01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BETADINE
®
VAGINAL DOUCHE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-Iodine Ph. Eur. 10% w/v.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BETADINE
®
VAGINAL DOUCHE is indicated for vaginal infections (Intra-Vaginal
use). It offers
rapid relief of symptoms such as burning or irritation.
It is used as vaginal cleanser for the treatment of vaginitis
(inflammation of the vagina) due to
candidal, trichomonal, non-specific or mixed infections and for
pre-operative disinfection of the
vagina.
BETADINE
®
VAGINAL DOUCHE contains Povidone-Iodine, which is broad-spectrum
germicide.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
BETADINE
®
VAGINAL DOUCHE is contraindicated in pre-puberty children (see section
4.3).
Method of administration
For Intra-Vaginal use. Adults and the elderly.
Use once a day preferably in the morning for up 14 days (including
days of the menstrual
cycle) or as directed by the doctor.
•
Add two measuring capfuls of the concentrate to the squeeze bottle.
•
Fill the squeeze bottle with lukewarm water.
•
Screw the applicator to the squeeze bottle and shake gently.
•
Carefully insert the applicator high into the vagina without causing
discomfort. Expel as much
cleansing liquid as possible by gentle pressure on the sides of the
squeeze bottle, allowing
solution to run freely from the vagina.
•
Remove the applicator from the vagina allowing air to enter the
squeeze bottle, so that it
regains its original shape.
•
Re-insert
the
applicator
into
the
vagina
squeezing
once
again
to
cleanse
the
vagina
thoroughly.
•
Repeat until all the BETADINE
® VAGINAL DOUCHE has been used.
•
Finally rinse away the excess solution from around the vagina with a
clean sponge or a flannel.
Dry the vaginal area with a clean cloth or paper towel.
•
Rinse clean the empty bottle and applicat