Lidotec 700 mg medicated plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine

Available from:

Grunenthal Pharma Ltd

ATC code:

N01BB; N01BB02

INN (International Name):

Lidocaine

Dosage:

5 percent

Pharmaceutical form:

Medicated plaster

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amides; lidocaine

Authorization status:

Not marketed

Authorization date:

2017-01-27

Summary of Product characteristics

Health Products Regulatory Authority
17 October 2019
CRN009DPC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lidotec 700 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 cm x 14 cm plaster contains 700 mg lidocaine (5%w/w)
Excipients with known effect:
Methyl parahydroxybenzoate 14 mg
Propyl parahydroxybenzoate 7 mg
Propylene glycol 700 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
White hydrogel plaster containing adhesive material, which is applied
to a non-woven polyethylene terephthalate backing
embossed with “Lidocaine 5%” and covered with a polyethylene
terephthalate film release liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lidotec is indicated for the symptomatic relief of neuropathic pain
associated with previous herpes zoster infection
(post-herpetic neuralgia, PHN) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_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. If there has
been no response to Lidotec after this period (during
the wearing time and/or during the plaster-free interval