Source: Health Products and Food Branch (CA) Revision Year: 2019
Benzydamine hydrochloride is contraindicated in subjects with a history of hypersensitivity to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
The use of undiluted PHARIXIA and PHARIXIA ALCOHOL FREE may produce local irritation manifested by burning sensation in patients with mucosal defects. If necessary, it may be diluted (1:1) with lukewarm water.
Since benzydamine hydrochloride is absorbed from oral mucosa and then excreted mostly unchanged in the urine, a possibility of its systemic action has to be considered in patients with renal impairment.
The safety of benzydamine hydrochloride has not been established in pregnant patients. Risk to benefit ratio should be established if PHARIXIA and PHARIXIA ALCOHOL FREE is to be used in these patients.
Safety and dose directions have not been established for children five years of age and younger.
The most frequent adverse reactions reported are: local numbness (9.7%), local burning or stinging sensation (8.2%), nausea and/or vomiting (2.1%).
The least frequent were reports of throat irritation, cough, dryness of the mouth associated with thirst, drowsiness and headache.
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