Savlon Antiseptic and Pain Relief Gel

Gel Colourless, viscous gel with a characteristic menthol odour.

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.4.3 Contraindications 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. **Excipient warnings**: This medicine contains 10%w/w propylene glycol (E1520) per application, which may cause skin irritation.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.4.9 Overdose Overdosage effects are unlikely as the systemic dose from this topical product is likely to be very low.

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.

6.1 List of excipients Hypromellose Polysorbate 20 Nonoxinol 9 Propylene Glycol (E1520) Levomenthol Purified Water6.2 Incompatibilities None known.6.3 Shelf life 36 months. Shelf life after opening of the tube: 3 months6.4 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, 20g6.6 Special precautions for disposal and other handling No special requirements.