SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

‘Hibitane’ Antiseptic Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Gluconate 1% w/w.

(incorporated as Chlorhexidine Gluconate Solution Ph.Eur)

For a full list of excipients, see Section 6.1

3    PHARMACEUTICAL FORM

Cream.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

‘Hibitane’ Antiseptic Cream is an antimicrobial preparation designed for application to broken skin surfaces. It may also be applied to the hands of nurses, surgeons and other hospital staff as a barrier against bacterial infection.

4.2    Posology and method of administration

Posology

For use by adults, children and the elderly

There are no special dosage recommendations for either elderely patients or children.

Method of Administration For cutaneous use only

Apply liberally to the wound and surrounding skin, or to the hands.

4    CLINICAL PARTICULARS

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

Hibitane Antiseptic Cream contains chlorhexidine. Chlorhexidine 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. Hibitane Antiseptic Cream 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).

For external use only. Keep out of the eyes and avoid contact with the brain, meninges and ears. As with any other antiseptic agents, antimicrobial activity may be diminished through incompatibility or tin the presence of significant quantities of organic matter.

Hibitane Antiseptic Cream contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should avoid Hibitane Antiseptic Cream

4.5    Interaction with other medicinal products and other forms of interaction

See section 6.2.

4.6    Fertility, pregnancy and lactation

Pregnancy

There is no evidence of any adverse effects on the foetus arising from the use of ‘Hibitane’ Antiseptic Cream during pregnancy and lactation. Therefore no special precautions are recommended

Lactation

There is no evidence of any adverse effects on the foetus arising from the use of ‘Hibitane’ Antiseptic Cream during pregnancy and lactation. Therefore no special precautions are recommended.

4.7    Effects on ability to drive and use machines

Hibitane Antiseptic Cream has no or negligible influence on the ability to drive and use machines

4.8 Undesirable effects

Skin disorders:

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

Immune disorders:

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

System Organ Class	Common ( ^ 1% < 10%)	Uncommon ( *0.1% < 1%)	Rare 0.01%<0.1%)	Frequency not known (* 0.001%<0.01%)
Skin and Subcutaneous Tissue Disorders		Irritation (Skin)		Allergic skin reactions
Immune System Disorders				Hypersensitivity anaphylactic shock

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, Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

This has not been reported.

Accidental ingestion

Chlorhexidine taken orally is poorly absorbed. Treat with gastric lavage using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5 PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

ATC code: D08AC02

Hibitane Antiseptic Cream is a topical agent for external use only and is not intended to be administered orally or parenterally. Because of its cationic nature,

Chlorhexidine binds strongly to skin surfaces, mucosa or tissues and is thus poorly absorbed. There are, as a consequence, no general pharmacological studies on Chlorhexidine available and its effects on internal organs are minimal. If absorbed, there is no evidence of metabolic cleavage of the drug.

Chlorhexidine gluconate is a broad spectrum topical antimicrobial agent with activity against a wide range of gram-positive and gram-negative bacteria, dermatophytes (including the yeast-like fungus Candida) and enveloped viruses (including Human Immunodeficiency Virus (the AIDS virus).

5.2 Pharmacokinetic properties

Chlorhexidine gluconate has been found to be very poorly absorbed when administered by all routes in the various species tested and no detectable blood levels have been found in man following oral use. Attempts to detect percutaneous absorption in man were made using three different studies -single application repeated application and hospital usage, chlorhexidine being applied either as a 5% aqueous solution or as a 4% formulated hand wash. Samples of skin, faeces and urine were tested for up to 10 days together with blood samples taken over 24 hours. From all these studies it is concluded that the percutaneous absorption of chlorhexidine, if it occurs at all, it is exceedingly small and insignificant - the limit of detection used being in the order of 0.005pg/ml.

It is unlikely that the pharmacokinetic properties of chlorhexidine gluconate will be altered significantly in special situations such as hepatic failure, renal failure, treatment of children, the elderly or in pregnancy and lactation.

5.3 Preclinical safety data

Chlorhexidine is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Arachis oil

Butylated hydroxytoluene Cetostearyl Alcohol.

Cetostearyl Alcohol/Ethylene Oxide condensate

d-Gluconolactone

Liquid Paraffin

Methyl hydroxybenzoate.

Perfume

Propyl hydroxybenzoate Purified Water

6.2 Incompatibilities

Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing chlorhexidine.

Chlorhexidine is incompatible with soap and other anionic agents.

6.3 Shelf life

2 years.

6.4    Special precautions for storage

Do not store above 25 ^oC.

6.5    Nature and contents of container

Internally lacquered collapsible aluminium tube (50g).

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

QP Services UK Limited 46 High Street,

Yatton,

Somerset,

BS49 4HJ,

United Kingdom.

MARKETING AUTHORISATION NUMBER(S)

PL 29498/0001

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/01/2006

DATE OF REVISION OF THE TEXT

06/01/2016