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Novartis Consumer Health
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Telephone: +44 (0)1403 210 211
Fax: +44 (0)1403 323 919
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1403 218 111
Medical Information Fax: +44 (0)1403 324 024

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Summary of Product Characteristics last updated on the eMC: 14/01/2009
SPC Savlon Antiseptic Liquid


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1. NAME OF THE MEDICINAL PRODUCT

Savlon Antiseptic Liquid


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients: Cetrimide 3.0% w/v
  Chlorhexidine Gluconate 0.3% w/v

For excipients, see Section 6.1.


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3. PHARMACEUTICAL FORM

Liquid


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

A general antiseptic for external first-aid use.


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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 ½ litre of warm water
- Personal hygiene and midwifery 2 capfuls (30ml) to a ½ litre of warm water
- Bathing5 capfuls (75ml) to the bathwater

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4.3 Contraindications

None known.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

No known restriction.


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4.7 Effects on ability to drive and use machines

The ability to drive or use machines is not affected.


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4.8 Undesirable effects

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


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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.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Isopropyl alcohol

Terpineol

Liquid deodoriser S53272TP

Benzyl benzoate

D-Gluconolactone

Sodium hydroxide

Purified water


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6.2 Incompatibilities

None


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6.3 Shelf life

36 months


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6.4 Special precautions for storage

Do not store above 25°C


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6.5 Nature and contents of container

Colourless (clear) or blue (clear) blow moulded PVC plastic bottles 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.


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6.6 Special precautions for disposal and other handling

Medicines should be kept out of the reach of children.


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7. MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Limited

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00030/0126


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23 May 2003


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10. DATE OF REVISION OF THE TEXT

21 November 2008.

Legal category: GSL



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21041/SPC/


Active Ingredients/Generics

 
  cetrimide
  chlorhexidine gluconate