LIDOTEC 5 Per Cent Medicated Plaster

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE

Available from:

Grünenthal Ltd

ATC code:

N01BB02

INN (International Name):

LIDOCAINE

Dosage:

5 Per Cent

Pharmaceutical form:

Medicated Plaster

Prescription type:

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

Therapeutic area:

Amides

Authorization status:

Authorised

Authorization date:

2017-01-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIDOTEC 700 MG MEDICATED PLASTER
Lidocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lidotec is and what it is used for
2.
What you need to know before you use Lidotec
3.
How to use Lidotec
4.
Possible side effects
5.
How to store Lidotec
6.
Contents of the pack and other information
1.
WHAT LIDOTEC IS AND WHAT IT IS USED FOR
Lidotec contains lidocaine, a local analgesic, which works by reducing
the pain in your skin.
You have been given Lidotec to treat a painful skin condition called
post-herpetic neuralgia. This is generally
characterised by localised symptoms such as burning, shooting or
stabbing pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LIDOTEC
DO NOT USE LIDOTEC
-
if you are allergic to lidocaine or any of the other ingredients of
this medicine (listed in section 6)
-
if you have had an allergic reaction to other products which are
similar to lidocaine, such as bupivacaine,
etidocaine, mepivacaine or prilocaine
-
on injured skin or open wounds
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Lidotec.
If you have severe liver disease, or severe heart problems, or severe
kidney problems, you should talk to your
doctor before using Lidotec.
Lidotec should only be used on the areas of skin after the shingles
has healed. It should not be used on, or
near the eyes or mouth.
Lidocaine is broken down in your liver to several compounds. One of
these compounds is 2,6 xylidine which
has been shown to cause tumours in rats whe

Summary of Product characteristics

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),
treatment must be discontinued as potential risks may
outweigh benefits