Vobolon 700 mg Medicated Plaster
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-02-2018
Summary of Product characteristics
(SPC)
18-09-2021
Active ingredient:
Lidocaine
Available from:
Grunenthal Pharma Ltd
ATC code:
N01BB; N01BB02
INN (International Name):
Lidocaine
Dosage:
700 milligram(s)
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:
2018-01-19
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOBOLON 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 Vobolon is and what it is used for
2.
What you need to know before you use Vobolon
3.
How to use Vobolon
4.
Possible side effects
5.
How to store Vobolon
6.
Contents of the pack and other information
1.
WHAT VOBOLON IS AND WHAT IT IS USED FOR
Vobolon contains lidocaine, a local analgesic, which works by reducing
the pain in your skin.
You have been given Vobolon 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 VOBOLON
DO NOT USE VOBOLON
-
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 Vobolon.
If you have severe liver disease, or severe heart problems, or severe
kidney problems, you should talk to your
doctor before using Vobolon.
Vobolon 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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
17 September 2021
CRN00CCSH
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vobolon 700 mg Medicated Plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 cm x 14 cm plaster contains 700 mg lidocaine (equivalent to
5%w/w)
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 14 mg
Propyl parahydroxybenzoate (E216) 7 mg
Propylene glycol (E1520) 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
Vobolon 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 Vobolon after this period (during
the wearing time an
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