SAVLON ANTISEPTIC LIQUID - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Savlon Antiseptic Liquid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients: Cetrimide 3.0% w/v

Chlorhexidine Gluconate 0.3% w/v

3 PHARMACEUTICAL FORM

Liquid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A general antiseptic for external first-aid use.

4.2 Posology and method of administration

Adults, children and elderly:

Savlon Antiseptic Liquid is for external use only and must be diluted with water as follows:

– First aid for cuts, grazes, minor burns and bites 2 capfuls (30ml) to a ^ litre of warm water

– Personal hygiene and midwifery                2 capfuls (30ml) to a ^ litre of

warm water

– Bathing                                        5 capfuls (75ml) to the bathwater

4.3 Contraindications

None known.

4.4 Special warnings and precautions for use

Keep all medicines out of the reach of children.

Keep out of the eyes and ears.

Treat accidental splashes by washing open eyes with water for at least ten minutes, seek medical advice.

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Savlon Antiseptic Liquid, care must be taken to ensure no excess product is present prior to application of the dressing.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation No known restriction.

4.7 Effects on ability to drive and use machines

The ability to drive or use machines is not affected.

4.8 Undesirable effects

In rare cases, skin irritation may occur; stop using and seek medical advice.

Chemical burns in neonates (frequency unknown)

4.9 Overdose

If swallowed, wash out of mouth and drink plenty of milk or water; seek medical advice and show the container to the doctor.

5.1 Pharmacodynamic properties

Chlorhexidine is an effective antiseptic with a wide range of activity against micro organisms, including gram positive and gram negative bacteria, fungi and viruses.

Cetrimide is a quaternary ammonium compound with surfactant and antiseptic properties.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6.1

Isopropyl alcohol

Terpineol

Liquid deodoriser S53272TP

Benzyl benzoate D-Gluconolactone

Sodium hydroxide Purified water

6.2

None.

6.3

36 months.

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Colourless (clear) or blue (clear) blow moulded PVC plastic bottle with polypropylene screw cap.

White HDPE bottle with a polypropylene screw cap.

Pack sizes: 115 ml, 125 ml, 250 ml, 450 ml, 495 ml, 500 ml, 550 ml, 600 ml, 750 ml, 900 ml, 5000 ml.

6.6 Special precautions for disposal

Medicines should be kept out of the reach of children.

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 44673/0115

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

Date of renewal: 1 November 1997