PLIAGLIS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE ; TETRACAINE

Available from:

Galderma (UK) Ltd

ATC code:

N01BB52

INN (International Name):

LIDOCAINE ; TETRACAINE

Dosage:

70+70 mg/g

Pharmaceutical form:

Cream

Prescription type:

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

Therapeutic area:

lidocaine, combinations

Authorization status:

Not Marketed

Authorization date:

2012-07-20

Patient Information leaflet

70 mg/g + 70 mg/g, cream
(lidocaine & tetracaine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLIAGLIS 70 MG/G + 70 MG/G CREAM
Lidocaine and Tetracaine
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 Pliaglis is and what it is used for
2.
What you need to know before you use Pliaglis
3.
How to use Pliaglis
4.
Possible side effects
5.
How to store Pliaglis
6.
Contents of the pack and other information
1.
WHAT PLIAGLIS IS AND WHAT IT IS USED FOR
Pliaglis is a cream containing local anaesthetics, lidocaine and
tetracaine which are used to numb an area of skin before a
painful procedure such as needle insertion or laser treatments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PLIAGLIS
DO NOT USE PLIAGLIS
- if you are allergic to lidocaine or tetracaine, any similar local
anaesthetics or any of the other ingredients of this medicine
(listed in section 6).
- if you know that you are allergic to para-aminobenzoic acid
(sometimes called PABA), a substance that is made when
your body breaks down tetracaine, methyl parahydroxy-
benzoate (E218) or propyl parahydroxybenzoate (E216)
- on broken or irritated skin
- on mucous surfaces such as your mouth
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Pliaglis
- if you have problems with your liver, kidney or heart
- if you are very ill or physically weak as you may be more
sensitive to Pliaglis
Take care to avoid contact with the eyes. If Pliaglis comes into
contact with your eye, immediately rinse your eye with water
or salt solution and prot

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pliaglis 70mg/g + 70mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of cream contains 70 mg lidocaine and 70 mg tetracaine.
Excipients with known effect:
methyl parahydroxybenzoate (E218)
0.5 mg/g
propyl parahydroxybenzoate (E216) 0.1 mg/g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White to off-white viscous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pliaglis is indicated in adults to produce local dermal anaesthesia on
intact skin prior to dermatological procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For use in adults and elderly:
For dermatological procedures such as pulsed-dye laser therapy,
laser-assisted hair removal, non-ablative laser facial
resurfacing, dermal filler injections and vascular access, Pliaglis
should be applied onto intact skin at a thickness of
approximately 1mm for 30 minutes (approximately 1.3 g of cream per 10
cm
2
). After the required time, the peel must
then be removed from the skin prior to the procedure.
For dermatological procedures such as laser-assisted tattoo removal,
and laser leg vein ablation, Pliaglis should be
applied onto intact skin at a thickness of approximately 1mm for 60
minutes (approximately 1.3 g of cream per
10 cm
2
).
After the required time, the peel must then be removed from the skin
prior to the procedure.
The maximum application area should not exceed 400 cm
2
.
Surface Area of Treatment Site
(cm2)
Approximate weight of Pliaglis
Dispensed (g)
10
1.3
2 fingertip units
50
6.5
Half content of a 15g tube
100
13
Full content of a 15g tube
200
26
Full content of a 30g tube
400
52
Full content of two 30g tubes
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___