DENELA 5 Per Cent Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE, PRILOCAINE

Available from:

Teva B.V.

ATC code:

N01BB20

INN (International Name):

LIDOCAINE, PRILOCAINE

Dosage:

5 Per Cent

Pharmaceutical form:

Cream

Prescription type:

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

Therapeutic area:

Amides

Authorization status:

Authorised

Authorization date:

2017-11-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DENELA 5% CREAM
(FOR 5 G AND PRE-MEDICATION PACKS)
(FOR 30 G SURGICAL PACKS)
LIDOCAINE & PRILOCAINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse
has told 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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What DENELA CREAM is and what it is used for?
2.
What you need to know before you use DENELA CREAM
3.
How to use DENELA CREAM
4.
Possible side effects
5.
How to store DENELA CREAM
6.
Contents of the pack and other information
1.
WHAT DENELA CREAM IS AND WHAT IT IS USED FOR
Denela Cream contains two active substances called lidocaine and
prilocaine. These belong to a
group of medicines called local anaesthetics.
Denela Cream works by numbing the surface of the skin for a short
time. It is put on the skin
before certain medical procedures. This helps to stop pain on the
skin; however you may still
have the feelings of pressure and touch.
_ _
_Adults, Adolescents and Children: _
It can be used to numb the skin before:
-
Having a needle put in (for example, if you are having an injection or
a blood test).
-
Minor skin operations.
_Adults and Adolescents: _
It can also be used on adults to numb the genitals before:
-
Having an injection.
-
Medical procedures such as removal of warts.
A doctor or nurse should supervise the use of Denela Cream on the
genitals.
_Adults: _
It can also be used to numb the skin before:
-
Cleansing or removal of damaged skin of leg ulcers
For other purposes than application to int

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Denela 5% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 25 mg of lidocaine and 25 mg of
prilocaine.
Excipient with known effect: macrogolglycerol hydroxystearate. Each
gram of cream contains 19 mg of
macrogolglycerol hydroxystearate (hydrogenated polyoxyl castor oil)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White soft cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Denela 5% Cream is indicated for:
-
Topical anaesthesia of the skin in connection with:
-
needle insertion and injections eg. intravenous catheters, blood
sampling or vaccination;
-
superficial surgical procedures, e.g.laser treatment and hair removal
-
in adults and in the paediatric population.
-
Topical anaesthesia of the genital mucosa, e.g. prior to superficial
surgical procedures or infiltration
anaesthesia in adults and adolescents
12 years.
-
Topical anaesthesia of leg ulcers to facilitate mechanical
cleansing/debridement in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents_
The details of the Indications or Procedures for use, with Dosage and
Application Time are provided in Tables 1
and 2.
For further guidance on the appropriate use of the product in such
procedures, please refer to_ Method of_
_administration_.
TABLE 1 ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE
INDICATION/PROCEDURE
DOSAGE AND APPLICATION TIME
SKIN
Minor procedures e.g. needle insertion and
surgical treatment of localised lesions.
2 g (approx. half a 5 g tube) or approx. 1.5g/10cm
2
for
1 to 5 hours
1)
Dermal surgical procedures on larger areas in a
hospital setting e.g. split skin grafting.
Approx. 1.5-2 g/10 cm
2
for 2 to 5 hours
1)
Dermal procedures on newly shaven skin of large
Maximum recommended dose: 60g.
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