Lidoderm patch is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).
The painful area should be covered with the plaster once daily for up to 12 hours within a 24 hours period. Only the number of plasters that are needed for an effective treatment should be used. When needed, the plasters may be cut into smaller sizes with scissors prior to removal of the release liner. In total, not more than three plasters should be used at the same time.
The plaster must be applied to intact, dry, non-irritated skin (after healing of the shingles).
Each plaster must be worn no longer than 12 hours. The subsequent plaster-free interval must be at least 12 hours.
The plaster must be applied to the skin immediately after removal from the sachet and following removal of the release liner from the gel surface. Hairs in the affected area must be cut off with a pair of scissors (not shaved).
Treatment outcome should be re-evaluated after 2-4 weeks. If there has been no response to Versatis after this period or if any relieving effect can solely be related to the skin protective properties of the plaster, treatment must be discontinued as potential risks may outweigh benefits in this context (see sections 4.4 and 5.1). Treatment should be reassessed at regular intervals to decide whether the amount of plasters needed to cover the painful area can be reduced, or if the plaster-free period can be extended.
The most commonly reported adverse reactions were administration site reactions including erythema, rash, application site pruritus, application site burning, application site dermatitis, application site erythema, application site vesicles, dermatitis, skin irritation, and pruritus.
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