Savlon Dry Antiseptic

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Povidone-iodine

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

D08AG; D08AG02

INN (International Name):

Povidone-iodine

Dosage:

1.14 percent weight/weight

Pharmaceutical form:

Cutaneous spray, powder

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Iodine products; povidone-iodine

Authorization status:

Not marketed

Authorization date:

1986-05-12

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Savlon Dry Antiseptic.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Spray powder containing 1.14% w/w of Povidone Iodine with an available
iodine content of 5% w/w in the powder.
_For full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Cutaneous spray, powder.
Pressurised Cutaneous Spray.
Orange/brown micronised powder and propellants.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the topical prophylaxis and treatment of superficial infections or
injuries of skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply to the affected area by spraying from a distance of 15 to 22 cm.
Special populations;
_Children:_ There are no special dosage recommendations for children.
However, povidone-iodine is not recommended
for regular use in neonates and is contra-indicated in very low birth
weight infants (below 1500g).
_Renal Impairment:_
Avoid regular application to inflammed or broken skin.
4.3 CONTRAINDICATIONS
Savlon Dry is contraindicated in patients with thyroid disorders, in
particular overactive thyroid (hyperthyroidism),
nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis.
Hypersensitivity to povidone iodine or any other ingredient of the
spray.
Povidone iodine containing products are contra-indicated for preterm
neonates gestational age under 32 weeks.
Use near nose or mouth.
Scheduled radioiodine therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Iodine absorption may interfere with tests of thyroid function.
Application to extensive areas of broken skin may lead to excessive
absorption of iodine.
Regular or prolonged use should be avoided in patients receiving
lithium therapy (refer to section 4.5).
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