Savlon Bites & Stings Pain Relief Gel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Savlon Bites & Stings Pain Relief Gel Or
Savlon Dual Action Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Lidocaine Hydrochloride 2.0% w/w
Zinc Sulphate 1.0% w/w
Cetrimide 0.5% w/w
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel
Colourless, viscous gel with a characteristic menthol odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of pain, itching, irritation, and for antiseptic protection. For use in insect bites and stings, and skin reactions such as nettle rash, caused by contact with plants.
4.2 Posology and method of administration
Adults and children over 12 years: Apply a small amount to the affected area with a fingertip. Repeat if required up to 3-4 times daily.
Children under 12 years: Not recommended (insufficient data available).
Route of administration: For cutaneous use.
Patients with a known hypersensitivity to any ingredient should not use the product.
4.4 Special warnings and precautions for use
Contact with the eyes should be avoided. For external use only.
Not suitable for animal bites.
Keep out of the sight and reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No known interactions with other drugs.
4.6 Fertility, Pregnancy and lactation
There are no known adverse effects in normal use of this product in pregnancy and lactation.
Exposure to systemically absorbed lidocaine from the product is low. The active ingredients have been in use for many years and no special precautions are considered necessary.
4.7 Effects on ability to drive and use machines
There are no known adverse effects on driving and using machinery.
The active ingredients have been in use for many years at much higher levels of exposure and no precautions are considered necessary for use in driving and using machinery.
4.8 Undesirable effects
Rarely, skin irritation and sensitisation may occur.
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.
Overdosage effects are unlikely as the systemic dose from this topical product is likely to be very low.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Three pharmacological effects are provided:
Lidocaine hydrochloride is a local anaesthetic of the amide type which is widely used for local application to the skin and mucous membranes. It produces surface anaesthesia by diminishing or preventing the conduction of sensory nerve impulses.
Cetrimide is a quaternary ammonium antiseptic. As well as having emulsifying and detergent properties, it has antibacterial activity against gram-positive organisms and to a lesser extent against some gram-negative organisms.
Zinc sulphate has astringent and soothing properties.
5.2 Pharmacokinetic properties
The product is intended for local action. Lidocaine hydrochloride is well-absorbed through mucous membranes and more slowly absorbed through intact skin.
5.3 Preclinical safety data
No relevant information is available other than that given in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydroxyethylmethylcellulose
Polysorbate 20 Nonoxynol 9 Propylene Glycol Levomenthol Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
Shelf life after opening of the tube: 3 months
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
Laminated tube consisting of aluminium foil coated internally and externally with low density polyethylene or high density polyethylene.
Pack size: 3g, 20g
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0110
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/10/2006
10
DATE OF REVISION OF THE TEXT
24/02/2016