Lidotec 700 mg pleister

Country: Holland

Tungumál: hollenska

Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Virkt innihaldsefni:

LIDOCAÏNE

Fáanlegur frá:

Grunenthal B.V.

ATC númer:

N01BB02

INN (Alþjóðlegt nafn):

LIDOCAINE

Lyfjaform:

Pleister

Samsetning:

ALUMINIUMGLYCINAAT MONOHYDRAAT ; DINATRIUMEDETAAT 2-WATER ; GELATINE (E 441) ; KAOLIEN ; METHYLPARAHYDROXYBENZOAAT (E 218) ; POLYACRYLAAT NATRIUM ; POLYACRYLZUUR ; POLYVINYLALCOHOL (E1203) ; PROPYLEENGLYCOL (E 1520) ; PROPYLPARAHYDROXYBENZOAAT (E 216) ; SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420) ; UREUM (E 927B) ; WATER, GEZUIVERD ; WIJNSTEENZUUR (D-,L-),

Stjórnsýsluleið:

Cutaan gebruik

Lækningarsvæði:

Lidocaine

Vörulýsing:

Hulpstoffen: ALUMINIUMGLYCINAAT MONOHYDRAAT; DINATRIUMEDETAAT 2-WATER; GELATINE (E 441); KAOLIEN; METHYLPARAHYDROXYBENZOAAT (E 218); POLYACRYLAAT NATRIUM; POLYACRYLZUUR; POLYVINYLALCOHOL (E1203); PROPYLEENGLYCOL (E 1520); PROPYLPARAHYDROXYBENZOAAT (E 216); SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420); UREUM (E 927B); WATER, GEZUIVERD; WIJNSTEENZUUR (D-,L-);

Leyfisdagur:

2017-06-20

Upplýsingar fylgiseðill

Lidotec 700 mg medicated plaster
Page 1 of 6
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIDOTEC 700 MG PLEISTER
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 be

Vara einkenni

Lidotec 700 mg medicated plaster
Page 1 of 8
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lidotec
700 mg
pleister
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 discontinue