Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
MOUTHWASH
**DOSAGE AND ADMINISTRATION** Difflam® should generally be used undiluted, but if stinging occurs it may be diluted with water. The solution should be expelled from the mouth after use. Uninterrupted treatment should not exceed seven days. **Dosage in Adults** When used as a gargle, the usual dose Difflam® is 15 mL (approximately one tablespoon) which should be gargled for at least 30 seconds at 1½ to 3 hourly intervals, as needed. When used as a rinse for oral lesions, the usual dose is again 15 mL (approximately one tablespoon) which should be held in the mouth and swirled around for at least 30 seconds, with repeat use every 1½ to 3 hours throughout the day. **Dosage in Children** 5–15 mL as a gargle if able to do so, or as an oral rinse. **With Impaired Renal Function** Since absorbed benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with severe renal impairment. **With Impaired Liver Function** Since absorbed benzydamine is highly metabolised in the liver, possibility of systemic effects should be considered in patients with severe hepatic impairment.
ORAL
Medical Information
**INDICATIONS** Difflam® is indicated for the relief of painful conditions of the oral cavity including: tonsilitis, sore throat, radiation mucositis, aphthous ulcers, post orosurgical and periodontal procedures.
**CONTRAINDICATIONS** Difflam® is contraindicated in patients with known hypersensitivity to benzydamine or to any of the components of the vehicle.
A01AD02
benzydamine
Manufacturer Information
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Ensign Laboratories Pty Ltd
Active Ingredients
Documents
Patient Information Leaflets
Difflam Solution_PIL_Clean_.pdf
Approved: July 2, 2020