Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
LOZENGE
**DOSAGE AND ADMINISTRATION** Difflam Anti-inflammatory Lozenges should not be chewed. They should be slowly dissolved in the mouth. One lozenge should be sucked slowly every one to two hours as required up to a maximum of 12 lozenges per day. Uninterrupted treatment should not exceed seven days. **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 the possibility of systemic effects should be considered in patients with severe hepatic impairment.
ORAL
Medical Information
**INDICATIONS** For the temporary relief of painful conditions of the oral cavity including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, post-orosurgical and periodontal procedures, pharyngitis, swelling, redness and inflammatory conditions.
**CONTRAINDICATIONS** Patients with known hypersensitivity to benzydamine or to any of the components of the vehicle.
A01AD02
benzydamine
Manufacturer Information
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Unique Pharmaceuticals Laboratories
Active Ingredients
Documents
Patient Information Leaflets
Difflam Lozenge 3mg PIL.pdf
Approved: August 16, 2018