Clinical studies
For the treatment and prevention of sore throats
Benzydamine hydrochloride is used as an adjunct in the symptomatic relief of painful inflammatory conditions of the throat and mouth. 3,4
After dental surgery
Rinsing with benzydamine after dental surgery reduced pain and inflammation and improved healing of the surgical site.3
For post-tonsillectomy and post-operative sore throat (POST)
Benzydamine hydrochloride is a simple and effective method to reduce the incidence and severity of POST.5,6
Studies suggest gargling benzydamine hydrochloride 0.15% has been found to reduce the incidence and severity of postoperative sore throat5. Similarly, benzydamine hydrochloride oral rinse was effective and well tolerated for prophylactic treatment of radiation-induced oral mucositis.7
Difflam™ contains the active ingredient benzydamine hydrochloride which, after topical administration, is absorbed locally becoming concentrated in the inflamed tissue.1
Benzydamine hydrochloride is classed as a locally acting, non-steroidal
anti-inflammatory drug (NSAID), but has a different mechanism of action from other NSAIDs. In fact, benzydamine hydrochloride has local anaesthetic effects and gastroprotective effects (where topical administration is not associated with the gastrointestinal irritation seen with systemic NSAIDs).2
Benzydamine hydrochloride exerts an anti-inflammatory and analgesic effect by stabilising the cellular membrane and inhibiting prostaglandin synthesis.4,5
The information above outlines the findings of a number of studies supporting benzydamine hydrochloride, the active ingredient in Difflam.
References
- Cioli V et al. Review of Pharmacological Data on Benzydamine. Int J Tissue React. 1985; 7(3): 205-13.
- Quane PA et al. Pharmacology of benzydamine. Inflammopharmacology 1998; 6(2): 95-107.
- Difflam™ Spray, Summary of Product Characteristics. Accessed on www.medicines.ie. Accessed January 2024
- Difflam™ Oral Rinse, Summary of Product Characteristics. Accessed on www.medicines.ie. Accessed January 2024
- Agarwal A et al. An evaluation of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective sore throat: a prospective, randomized, single-blind study. Anesth Analg 2006; 103(4): 1001-1003.
- Hung NK et al. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg 2010; 111(4): 882-886.
- Kazemian A et al. Benzydamine for prophylaxis of radiation-induced oral mucositis in head and neck cancers: a double-blind placebo controlled randomized clinical trial. Eur J Cancer Care (Engl) 2009;18(2):174-178.
PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) FOR FULL PRESCRIBING INFORMATION
- Difflam™ Spray Patient information leaflet
- Difflam™ Spray Summary of Product Characteristics
- Difflam™ Oral Rinse Patient Information Leaflet
- Difflam™ Oral Rinse Summary of Product Characteristics
Reporting of adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie
Adverse reactions/events should also be reported to the marketing authorisation holder at email address: pv.ireland@viatris.com or phone 0044 (0) 800 1218267.
