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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Ear Drops.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine 5 % w/v
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ear drops, solution.
Iodine-coloured, clear, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an
antiseptic for the management of superficial ear infections.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For topical administration.
Three to four drops instilled by dropper four times daily,
or as directed by the physician.
4.3 CONTRAINDICATIONS
1.
Use in patients who are iodine-sensitive.
2.
Use in patients with perforated ear drum.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Care must be taken when applying the product to areas of broken
skin, as excessive absorption of iodine may occur.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None stated.
4.6 PREGNANCY AND LACTATION
Use in pregnancy and lactation should be limited and although no
adverse effects are anticipated when used at the
recommended dose, caution is recommended
and therapeutic benefit must be balanced
against possible effects of the
absorption of iodine on foetal thyroid function and development.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 24/10/2005_
_CRN 2016054_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
Povidone iodine may produce local skin reactions although
it is considered to be less irritant than iodine.
4.9 OVERDOSE
In the case of accidental ingestion
of large quantities of Betadine, symptomatic and
supportive treatment should be
provided with special attention to electrolyte balance and
renal and thyroid function.
5 PHARMACOLOGICAL PROPERT
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