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 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 and other handling

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

Company Contact Details
Reckitt Benckiser Healthcare (UK) Ltd
Address

RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK

Telephone

0333 2005 345

Customer Care direct line

0333 2005 345

WWW

http://www.reckittbenckiser.com

Medical Information Direct Line

0333 2005 345