⚠️ Warnings
Particular caution is required in patients with hepatic impairment, circulatory insufficiency, hypotension, bradycardia, conduction disturbances, shock, renal insufficiency, and epilepsy, in whom dose reduction is necessary. Special care is likewise advised when treating injured mucous membranes (which increase the absorption of lidocaine) and/or inflamed areas, the elderly or debilitated patients, and patients who are already receiving a lidocaine-type medicinal product or taking it for cardiac conditions.
Lidocaine EGIS cutaneous spray is potentially porphyrinogenic; for this reason, its use in patients with acute porphyria is only acceptable in urgent indications.
At the moment of application, the spray produces a burning sensation.
When the spray is applied to anaesthetise the buccal mucosa, the tongue is also affected by the anaesthetic, increasing the risk of bite injury. A portion of the dose may be swallowed by the patient and subsequently metabolised in the liver.
When applying Lidocaine EGIS cutaneous spray, the container must be held in an upright position. The product must not come into contact with the eyes. Entry of the spray into the airways must likewise be prevented (risk of aspiration). Application to the pharynx requires particular caution. A rapid rise in plasma lidocaine concentrations may occur, with an increased risk of systemic toxicity.
Hypersensitivity reactions to Lidocaine EGIS cutaneous spray occur very rarely.
Before use of the spray in procedures involving the pharynx or nasopharynx, the following must be borne in mind: lidocaine suppresses the gag reflex, reaches the larynx and trachea, and also suppresses the cough reflex, which may result in bronchopneumonia.
Lidocaine EGIS cutaneous spray must not be applied to the cuffs of endotracheal tubes made of plastic (PVC, but also others), as it may damage the cuff (forming pinhole defects), which may lead to loss of cuff pressure.
Paediatric population
Use of Lidocaine EGIS is not recommended for topical anaesthesia prior to tonsillectomy and adenoidectomy in children under 4 years of age. This warning is particularly important in children, as the swallowing reflex occurs more frequently in them than in adults. Owing to numbing of the tongue and buccal mucosa, there is a risk of bite injury.
Lidocaine is well absorbed through mucous membranes (especially the trachea) and also through broken skin. This must be taken into account, particularly in children when large areas are treated.
This medicinal product contains 31.72 mg of ethanol (alcohol) per dose.
Use on the skin:
On broken skin, it may cause a burning sensation.
Use on mucous membranes:
The amount of alcohol in one dose of this medicinal product is equivalent to less than 1 mL of beer or 1 mL of wine.
Such a small amount of alcohol in this medicinal product has no perceptible effects.
This medicinal product contains approximately 10.5 mg of propylene glycol per dose (spray).
Use on the skin:
Propylene glycol may cause skin irritation.
