EMLA PATCH TRANSDERMAL THERAPEUTIC SYSTEM

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

TRANSDERMAL THERAPEUTIC SYSTEM

Composition:

EACH PATCH CONTAINS LIDOCAINE 25,0 mg PRILOCAINE 25,0 mg

Authorization status:

Registered

Authorization date:

2000-01-02

Patient Information leaflet

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S1
EMLA PATCH 25 MG/ 25 MG TRANSDERMAL THERAPEUTIC SYSTEM
LIDOCAINE, PRILOCAINE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
EMLA PATCH is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use EMLA PATCH carefully to get the
best results from
it.
•
Keep this leaflet. You may need to read it again.
•
Do not share EMLA PATCH with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve within
a few
days.
WHAT IS IN THIS LEAFLET
1.
What ELMA PATCH is and what it is used for
2.
What you need to know before you use EMLA PATCH
3.
How to use EMLA PATCH
4.
Possible side effects
5.
How to store EMLA PATCH
6.
Contents of the pack and other information
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1.
WHAT EMLA PATCH IS AND WHAT IT IS USED FOR
EMLA PATCH is local anaesthetic which is used for pain relief on the
skin prior to
procedures such as needle insertion, minor and superficial skin
surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EMLA PATCH
DO NOT USE EMLA PATCH:
•
if you are hypersensitive (allergic) to lidocaine, prilocaine or any
other ingredients of
EMLA PATCH, or to any local anaesthetics.
•
in infants younger than 12 months who are being treated at the same
time with
other medicines that affect methaemoglobin levels in the blood. Ask
your doctor,
pharmacist or other healthcare provider.
WARNINGS AND PRECAUTIONS
Take special care with EMLA PATCH:
•
If you have had an allergic, unpleasant or unusual reaction to EMLA
PATCH or to
any other medicine.
•
Do not use EMLA PATCH on areas with skin rash, cuts, grazes or other
open
wounds. If any of these problems are present, check with your doctor
or pharmacist
before using the patch.
•
Avoid getting EMLA PATCH

Summary of Product characteristics

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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S1
1.
NAME OF THE MEDICINE
EMLA PATCH 25 MG/ 25 MG transdermal therapeutic system
2.
QUALITATIVE AND QUATITATIVE COMPOSITION
Each EMLA PATCH contains 25 mg of lidocaine and 25 mg of prilocaine.
For full list of excipients, see section 6.1
3.
PHARMACETICAL FORM
Patches
EMLA PATCH is a unit-dose formulation of lidocaine and prilocaine in
the form of an
occlusive dressing. An absorbent cellulose disc, saturated with 1 g of
EMLA
emulsion 5 %, is affixed to a laminate backing equipped with an
adhesive tape
frame. The contact surface area of the EMLA saturated disc is
approximately
10 cm
2
.
EMLA emulsion is an oil-in-water emulsion system in which the oil
phase consists of
a eutectic mixture of the base forms of lidocaine and prilocaine in
the ratio of 1:1.
EMLA PATCH consists of an occlusive dressing (user part) and a
protective liner
(closure part).
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The user part is composed of an absorbent white or off-white circular
cellulose disc
with a diameter of 3,5 cm, affixed to a thin, flexible backing
(aluminium/plastic
laminate) equipped with an adhesive tape around the cellulose disc.
The cellulose
disc is impregnated with 1 g of EMLA 5 % emulsion.
The closure part is composed of a closure laminate (aluminium/plastic
laminate)
comprising a recessed portion for the cellulose disc and a release
liner for the
adhesive. There is a hermetic peel-off seal between the backing and
the closure
laminate around the cellulose disc.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
EMLA PATCH is indicated for:
Topical anaesthesia of intact skin for minor procedures, such as
needle insertion and
superficial surgical treatment of localised lesions, where application
of EMLA PATCH
1 hour before the procedure is feasible.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
One or more patch(es) are applied to the skin area(s) se