Betadine 10 mg/ml Gargle and Mouthwash

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Iodinated povidone

متاح من:

Ayrton Saunders Ltd

ATC رمز:

D08AG02

INN (الاسم الدولي):

Iodinated povidone

جرعة:

10 milligram(s)/millilitre

الشكل الصيدلاني:

Mouthwash

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

povidone-iodine

الوضع إذن:

Not marketed

تاريخ الترخيص:

1983-04-01

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine 10 mg/ml Gargle and Mouthwash
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 1% w/v (equivalent to 0.1% w/v of available
iodine).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gargle, Mouthwash
Clear red-brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic in the management of local infections of the mouth
and oropharynx in dental surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral, as a gargle and mouthwash. The product should not be swallowed.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
History of abnormal thyroid function or goitre (in
particular nodular colloid goitre, endemic goitre and Hashimoto’s
thyroiditis). Use in children under six years of age.
Regular use should be avoided in patients on concurrent lithium
therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this preparation may interfere with tests of thyroid function.
Regular use must be avoided as prolonged use may
lead to the absorption of a significant amount of iodine particularly
in patients with renal insufficiency. Do not use for
more than 14 days. If symptoms occur suggesting changes in thyroid
function, these should be investigated.
In patients
with impaired renal function, blood levels of iodine should be
monitored.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Betadine Gargle and Mouthwash can permanently discolour white gold
jewellery and it is recommended that this type
of jewellery should be removed before using Betadine Gargle and
Mouthwash.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Use with concurrent lithium therapy has been shown to exhibit additive
hypothyroidic effects. Absorption of iodine
from povidone iodine through either intact skin or broken skin may
interfere with thyroid function tests. Contamination
with