Lanacane 3% cream

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Benzocaine

Beschikbaar vanaf:

Reckitt Benckiser Healthcare (UK) Ltd

ATC-code:

D04AB04

INN (Algemene Internationale Benaming):

Benzocaine

Dosering:

30mg/1gram

farmaceutische vorm:

Cutaneous cream

Toedieningsweg:

Cutaneous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 13030000; GTIN: 5010934001481 5010934001511

Bijsluiter

Reckitt Benckiser
0002 PL 00063/0671 CCDS update
1.3.2 Mock-up-leaflet-proposed
Lanacane Medicated Skin Cream EU National
Page 1

Productkenmerken

OBJECT 1
LANACANE CREME
Summary of Product Characteristics Updated 05-Mar-2015 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Lanacane Creme
2. Qualitative and quantitative composition
Active Ingredient
%
Specification
Benzocaine
3.0
E.P.
3. Pharmaceutical form
Emulsion creme in an aluminium tube.
4. Clinical particulars
4.1 Therapeutic indications
For symptomatic relief of minor pain, itching, and irritation in the
following localised skin conditions,
such as insect bites, nettle stings, minor skin abrasions, and
external genital and external anal itching.
4.2 Posology and method of administration
For short term use only. If pain persists for more than 7 days, or
worsens, seek medical advice.
POSOLOGY
For adults, the elderly and children aged12 years and over:
Apply a small amount to the affected area up to 3 times a day.
METHOD OF ADMINISTRATION
For topical administration.
4.3 Contraindications
Hypersensitivity to benzocaine or to any of the excipients listed in
section 6.1 or paraaminobenzoic acid
(PABA), parabens or paraphenylenediamine or to commercial hair dyes as
there is cross-sensitivity
between these products.
A history of allergy to local anaesthetics such as procaine, butacaine
or any other 'caine' anaesthetics.
In patients who have a history of or are suspected to have
methaemoglobinaemia (see section 4.8).
Do not use with sulphonamides (see section 4.5).
Do not use with cholinesterase inhibitors (see section 4.5).
Do not apply to large areas of skin, eczematous, sunburnt, infected or
broken skin.
4.4 Special warnings and precautions for use
Local anaesthetics should not be used in patients with complete heart
block.
Not for use on extensive body area or on the mouth or eyes or under
conditions in which significant
inhalation is likely.
4.5 Interaction with other medicinal products and other forms of
interaction
SULPHONAMIDES: Benzocaine is metabolised to para-aminobenzoic acid and
may antagonise the effects of
sulphonamides.
CHOLINESTERASE INHIBITORS: Cholinesterase inhibit