Prosil Details

PROSIL Logo Abridged Prescribing Information:

Composition: Lidocaine IP…….. 2.5% w/w, Prilocaine IP………. 2.5% w/w, Gel Base q.s

Indications & Dosage: Topical anaesthesia of the skin in connection with needle insertion, e.g. intravenous catheters or blood sampling; superficial surgical procedures; in adults and in the paediatric population, topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥ 12 years, topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only.

Contraindications: Hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients.

Adverse effects: Burning sensation, application site pruritus, application site erythema, application site oedema, application site warmth, application site pallor are the reported adverse drug effects.

Warning: When applied in the vicinity of the eyes, Lidocaine 2.5% w/w and Prilocaine 2.5 % w/w cream should be used with particular care since it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns.