Rapydan 70 mg/70 mg medicated plaster

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Lidocaine; Tetracaine

Предлага се от:

Eurocept International BV

АТС код:

N01BB; N01BB52

INN (Международно Name):

Lidocaine; Tetracaine

дозиране:

70 mg/70 milligram(s)

Лекарствена форма:

Medicated plaster

Вид предписание :

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

Терапевтична област:

Amides; lidocaine, combinations

Статус Оторизация:

Not marketed

Дата Оторизация:

2008-01-25

Листовка

RAPY IE+UK en var016 PIL Mar2017
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAPYDAN 70MG/70MG MEDICATED PLASTER
Lidocaine/Tetracaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Rapydan is and what it is used for
2.
Before you use Rapydan
3.
How to use Rapydan
4.
Possible side effects
5
How to store Rapydan
6.
Further information
1.
WHAT RAPYDAN IS AND WHAT IT IS USED FOR
Rapydan contains two local anaesthetics – lidocaine and tetracaine.
These medicines are used to numb a
small area of skin before a procedure that might be painful, such as
an injection or a minor surgical
procedure.
2.
BEFORE YOU USE RAPYDAN
DO NOT USE RAPYDAN
-
if you are allergic (hypersensitive) to lidocaine, tetracaine or
sodium borate or any of the other
ingredients of Rapydan (see section 6).
-
if you are allergic (hypersensitive) to other local anaesthetics.
-
if you are allergic (hypersensitive) to para-aminobenzoic acid, a
compound that is formed when your
body breaks down tetracaine.
Do not use Rapydan on broken or damaged skin or on mucous membranes,
e.g. inside the mouth or nose.
TAKE SPECIAL CARE WITH RAPYDAN
Tell your doctor or pharmacist
-
if you have problems with your liver, kidney or heart.
-
if you are very unwell or in poor physical condition, because you may
be more sensitive to the effects
of lidocaine and tetracaine.
Rapydan should be used with caution close to the eyes. If Rapydan
comes into contact with your eye,
immediately rinse your eye with water or salt solution and protect it
until feeling returns.
Rapydan contains a heat-releasing component that may reac

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rapydan 70 mg/70 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated plaster contains 70 mg of lidocaine and 70 mg of
tetracaine.
Excipients:
0.35 mg methyl parahydroxybenzoate, 0.07 mg propyl parahydroxybenzoate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster.
Oval, light brown plaster (approximate dimensions: 8.5 cm x 6.0 cm)
with a removable opaque plastic tray.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Surface anaesthesia of the skin in connection with needle puncture and
in cases of superficial surgical procedures (such
as excision of various skin lesions and punch biopsies) on normal
intact skin in adults.
Surface anaesthesia of the skin in connection with needle puncture on
normal intact skin in children from 3 years of
age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including elderly):_ 1 or at most 4 plasters simultaneously.
Maximum 4 plasters per 24 hours.
_Children from 3 years of age:_ 1 or at most 2 plasters
simultaneously. Maximum 2 plasters per 24 hours.
_Application time:_ 30 minutes.
The plaster should be applied for the duration of 30 minutes before
needle puncture or a
superficial surgical procedure is conducted as a shorter duration may
result in a decreased efficacy.
Please note that the medicated patch contains a heat-releasing
component that may reach a maximum temperature of
40°C, with a mean temperature of 26-34°C.
If considered necessary, hairs in the affected area can be cut off
(not shaved) before the plaster is applied to ensure that
there is adequate contact between the skin and the plaster.
Rapydan medicated plasters are for single use only, and should be used
immediately once the sachet has been opened.
Used plasters should be discarded carefully in accordance with
instructions given in section 6.6.
_Children under 3 years of age:_
Use of Rapydan is strongly discouraged for children under the age of 3
years due to insufficient clin