SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Savlon Antiseptic Wound Wash

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Gluconate 0.45% w/v For excipients, see Section 6.1.

3.    PHARMACEUTICAL FORM

Cutaneous spray, solution A clear, colourless liquid with a citrus odour.

4    CLINICAL PARTICULARS

4.1.    Therapeutic indications

For the cleansing and disinfection of minor wounds, cuts, grazes and minor abrasions including insect bites and stings.

4.2.    Posology and Method of Administration

Use undiluted and apply as required to the affected area.

The product is primarily intended to be used for children, but can also be used by adults.

The route of administration is cutaneous only.

4.3    Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

4.4    Special warnings and precautions for use

For external use only.

Avoid contact with the eyes middle ear, meninges and other nervous tissues. If accidentally splashed into the eye, the open eye should be irrigated for at least 10 minutes.

Savlon Antiseptic Woundwash contains:

• Chlorhexidine which is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of Chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Savlon Antiseptic Woundwash should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections

4.3 and 4.8).

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with the topical forms.

4.6    Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of chlorhexidine in pregnant women. The potential risk for humans is unknown but is most likely very low since chlorhexidine is poorly absorbed following topical application (see section 5.2).

Breast-feeding

It is not known whether chlorhexidine is excreted in breast milk. There is no adequate data from the use of chlorhexidine in breast-feeding women. However, it is unlikely that the product is excreted in breast milk, since the product is poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breast-feeding.

Fertility

No data are available on fertility outcomes.

4.7    Effects on ability to drive and use machines

Savlon has no influence on the ability to drive and use machines

4.8    Undesirable effects

Within each system organ class, the adverse drug reactions are presented in order of decreasing seriousness.

The frequency categories for each adverse drug reaction include: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

The listed adverse events have estimated frequencies from post-marketing reporting.

Immune system disorders

Very rare: Anaphylactic reaction Very rare: Angioedema, urticaria

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

Skin and subcutaneous tissue disorders

Very rare: Skin irritation

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters

Paediatric population

No investigations in children have been performed. However, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

4.9 Overdose

While accidental ingestion is unlikely to cause any systemic effects due to the poor absorption of chlorhexidine, ingestion of high concentrations could cause irritation of the gastrointestinal mucosa/gastritis. Gastric lavage might be needed. Symptomatic treatment should be employed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiseptics and disinfectants, ATC Code: D08AC02

The product is a topical solution for external use and is not intended for internal use. No general pharmacological studies on chlorhexidine are available.

Because of its strongly cationic nature, the active agent chlorhexidine gluconate binds to skin surfaces, mucosa or tissues and is consequently poorly absorbed and its effects on internal organs are minimal.

5.2. Pharmacokinetic Properties

Chlorhexidine gluconate is very poorly absorbed when administered orally in any species and no detectable blood levels have been found in man following oral use.

Due to the binding properties of chlorhexidine gluconate, the pharmacokinetics of this formulation at the strength of 0.45% are not considered relevant.

5.3 Preclinical safety data

There is minimal systemic absorption of chlorhexidine following topical administration. Preclinical data do not show genotoxic risk for chlorhexidine. Reproductive studies with chlorhexidine gluconate in animals have not revealed any teratogenic potential nor risk to the foetus.

6.1. List of Excipients

Polyoxyethylene polyoxypropylene block co-polymer Lauryl dimethyl amine oxide Herbacol 1 5393/T (perfume)

Polysorbate 20 D-gluconolactone Sodium hydroxide Purified water

6.2    Incompatibilities

Chlorhexidine is incompatible with anionic substances (e.g. soap, toothpaste).

6.3    Shelf life

18 months

6.4. Special Precautions for Storage

Do not store above 25°C

6.5. Nature and Contents of Container

Container:

PET container with snap pump spray or

PVC bottle with polypropylene screw cap closure.

Pack sizes:

100, 115, 125, 150 ml

Containers may be provided as items in first aid kit containers.

6.6. Instructions for Use, Handling and Disposal

None.

7    MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Limited

T/A Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 SAB

8. MARKETING AUTHORISATION NUMBER

PL 00030/0121

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Granted: 14^th September 1997

10 DATE OF REVISION OF THE TEXT

30/12/2014