Betadine suppositories vaginal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

povidone-iodine

Available from:

Alkaloid AD-Skopje

ATC code:

G01AX11

INN (International Name):

povidone-iodine

Dosage:

200mg

Pharmaceutical form:

suppositories vaginal

Units in package:

(14/2x7/)

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2021-05-25

Summary of Product characteristics

BETADINE
®
200 mg vaginal suppositories
_Module 1.3.2 Summary of Product Characteristics _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
BETADINE
®
200 mg vaginal suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal suppository contains 200 mg of povidone-iodine,
equivalent to 20 mg of
available iodine.
_ _
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM

vaginal suppository
Dark brown to red, bullet-shaped pessary.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Betadine
vaginal
suppositories
are
indicated
for
acute
and
chronic
vaginal
infections
(vaginitis)
caused
by
mixed
infections,
non-specific
infections,
Trichomonas
vaginalis
infections and mycotic (Candida albicans) infections, especially after
antibiotic or steroid
therapy.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Once a day, at bedtime, in lying position, insert previously
water-wetted vaginal pessary
deeply into the vagina.
Unless the doctor prescribes otherwise, usual therapy lasts 14 days,
in any time of the
menstrual cycle, including the days of menstrual bleedings.
Since leaking of the medicine out of the vagina can not always be
prevented, sanitary pads,
but not tampons are recommended.
This medicine is not intended for use in pre-pubertal children.
4.3.
CONTRAINDICATION
Betadine vaginal suppositories are contraindicated in:

known hypersensitivity to iodine;

hyperthyroidism;

dermatitis herpetiformis;

before
and after radioiodotherapy.
BETADINE
®
200 mg vaginal suppositories
_Module 1.3.2 Summary of Product Characteristics _
2
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Regular or prolonged use of povidone-iodine should be avoided in
patients on lithium therapy,
renal failure and thyroid disease.
Povidone-iodine is not recommended for use in patients with renal
failure due to the potential
for metabolic acidosis and nephrotoxicity.
Povidone-iodine is also not recommended for use in patients with
hepatic failure.
Betadine vaginal