DIFFLAM SPRAY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
BENZYDAMINE HYDROCHLORIDE
Available from:
PCO Manufacturing
Dosage:
0.15 %w/v
Pharmaceutical form:
Oromucosal Spray
Authorization date:
2011-05-20
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difflam Spray, 0.15% w/v, Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each puff (175 microlitres) contains 262.5 micrograms of benzydamine hydrochloride (0.15% w/v).
Excipient(s) : includes methyl parahydroxybenzoate (E218) and ethanol
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oromucosal spray
_Product imported from the UK_
Difflam spray is a metered dose spray containing a clear, colourless oromucosal spray solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the symptomatic relief of painful inflammatory conditions of the throat and mouth.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
FOR OROMUCOSAL ADMINISTRATION.
ADULTS AND ELDERLY: 4 to 8 puffs, 1½-3 hourly.
CHILDREN (6-12): 4 puffs, 1½-3 hourly.
CHILDREN UNDER 6: One puff to be administered per 4 kg body weight, up to a maximum of 4 puffs, 1½-3 hourly.
Because of the small amount of drug applied, elderly patients can receive the same dose as adults.
The spray should be directed onto the affected area. Uninterrupted treatment should not exceed seven days, except
under medical supervision.
4.3 CONTRAINDICATIONS
Use in patient with a known hypersensitivity (eg bronchospasm, rhinitis, urticaria) to this product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
If the condition is aggravated or not improved use should cease.
Contains methyl parahydroxybenzoate (E218). May cause allergic reactions (possibly delayed).
This medicinal product contains small amounts of ethanol (alcohol) less than 100mg per dose.
IRISH MEDICINES BOARD
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_Date Printed 25/05/2011_
_CRN 2067086_
_page numbe
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