Lanacane Creme
SUMMARY OF PRODUCT CHARACTERISTICS
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 inhibitors inhibit the metabolism of benzocaine.
4.6 Fertility, pregnancy and lactation
Do not use in pregnancy or during breast feeding without first consulting a
doctor.
Pregnancy
There are limited amounts of data from the use of benzocaine in pregnant women.
Breast feeding
There is insufficient information on the excretion of benzocaine metabolites in human milk.
Fertility
No known effects
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Adverse events which have been associated with benzocaine are given below, listed by system organ class and frequency. Frequencies are defined as: very common (> 1/10), common (>1/100 and <1/10), uncommon (> 1/1000 and <1/100), rare (> 1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
|
System Organ Class |
Frequency |
Adverse Event |
|
Blood and Lymphatic System Disorders |
Not known |
Methaemoglobinaemia |
|
Immune System Disorders |
Not known |
Hypersensitivity reactions, dermatitis allergic |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Symptoms
There have been no reports of over dosage with the use of benzocaine with this dosage form.
Management
In the unlikely case of over dosage, treatment should be symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antipruritics, incl. Antihistamines, Anesthetics, etc;
ATC Code: D04 AB04
Benzocaine applied to the skin acts as a topical local anaesthetic, acting on nerve endings and receptors, temporarily reducing the itching and minor pain associated with various thermal, mechanical or chemical stimuli. The vanishing creme base also helps soothe, lubricate, and protect irritated skin.
5.2 Pharmacokinetic properties
When used as directed, some benzocaine applied topically may be absorbed through the skin and mucous membranes and is hydrolysed by esterases in the plasma and in the liver, but this should be of negligible consequence. Benzocaine has the quickest onset and shortest duration of action of the commonly used topical anaesthetics.
5.3 Preclinical safety data
None
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorothymol, diethylene glycol monoethyl ether, docusate sodium, fragrance, glycerine, glycerol monostearate, isopropyl alcohol, stearic acid, sulfonated castor oil, triethanolamine, water, zinc oxide.
6.2 Incompatibilities
None known.
6.3 Shelf life
Five years.
6.4 Special precautions for storage
Store at room temperature (below 30°C).
6.5 Nature and contents of container
In 30 gram and 60 gram aluminium tubes with a membrane covered nozzle and white high density polyethylene cap, overpacked in a printed folding cardboard unit carton
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0671
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26th April 1990 / 23rd July 1996
10 DATE OF REVISION OF THE TEXT
25/02/2015