LIDOCAINE GRUNENTHAL

Adults and elderly patients 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 can be applied during the day or during the night. 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. 1). Long-term use of Lidocaine Grünenthal 700 mg medicated plaster in clinical studies showed that the number of plasters used decreased over time. Therefore 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.

Renal impairment In patients with mild or moderate renal impairment a dosage adjustment is not required. 4). Hepatic impairment In patients with mild or moderate hepatic impairment a dosage adjustment is not required. 4). Paediatric population The safety and efficacy of Lidocaine Grünenthal 700 mg medicated plaster in children below 18 years has not been established.

No data are available.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Approximately 16% of patients can be expected to experience adverse reactions. These are localised reactions due to the nature of the medicinal product.

The most commonly reported adverse reactions were administration site reactions (such as burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles). The table below lists adverse reactions that have been reported in studies of post herpetic neuralgia patients receiving the plaster.

They are listed by system organ class and frequency. Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Body system Adverse drug reaction Skin and subcutaneous tissues disorders Uncommon Skin lesion Injury, poisoning and procedural complications Uncommon Skin injury General disorders and administration site conditions Very common Administration site reactions The following reactions have been observed in patients receiving the plaster under post-marketing conditions: Body system Adverse drug reaction Injury, poisoning and procedural complications Very rare Open wound Immune system disorders Very rare Anaphylactic reaction, hypersensitivity All adverse reactions were predominantly of mild and moderate intensity.

Of those less than 5% lead to treatment discontinuation. 2). 9). Reporting of suspected 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.

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The plaster should not be applied to mucous membranes. Eye contact with the plaster should be avoided. The plaster contains propylene glycol (E1520) which may cause skin irritation. It also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

The plaster should be used with caution in patients with severe cardiac impairment, severe renal impairment or severe hepatic impairment. 3). Secondary metabolites have been shown to be mutagenic. The clinical significance of this finding is unknown.

2).

1. g. bupivacaine, etidocaine, mepivacaine and prilocaine. The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds.