Cetraben Protect Antimicrobial 1% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eczmol 1% w/w Cream
Cetraben Protect Antimicrobial 1% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 1% w/w.
(incorporated as Chlorhexidine Gluconate Solution 5.0 % v/w)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A white, smooth, pourable cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Chlorhexidine gluconate 1% Cream is an antimicrobial emollient which can also be used as an alternative to soap in the management of dry and pruritic skin conditions including eczema and dermatitis.
4.2 Posology and method of administration
For cutaneous use. For external use only.
For adults, the elderly, infants and children
For application to the skin
Apply to the affected areas as often as necessary.
For use as a soap substitute
Chlorhexidine gluconate 1% w/w Cream may also be used as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.
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 section 4.4 and 4.8)
4.4 Special warnings and precautions for use
Chlorhexidine gluconate 1% w/w 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.
Chlorhexidine gluconate 1% w/w 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 topical application only. Keep out of the eyes and ears and avoid contact with the brain and meninges.
Hypersensitivity to some of the ingredients of Chlorhexidine gluconate 1% w/w Cream may be more common in patients with leg ulcer or stasis dermatitis. This medicine should therefore be used in caution in these patients.
Chlorhexidine gluconate 1% w/w Cream contains the ingredient cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing chlorhexidine.
4.6 Fertility, pregnancy and lactation
There is no evidence of any adverse effects on the foetus arising from the use of chlorhexidine during pregnancy and lactation. Therefore no special precautions are recommended.
4.7 Effects on ability to drive and use machines
None have been reported or are known.
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).
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
Accidental Ingestion
Chlorhexidine taken orally is poorly absorbed. Since there is very little absorption of chlorhexidine in the digestive tract, accidental ingestion is very unlikely to cause systemic effects. Symptoms of an overdose resemble those of alcohol intoxication (drunkenness). Nausea, vomiting, slurred speech, a staggering walk, and drowsiness may develop. In the case of massive ingestion gastro-intestinal irritation may be observed, and also hepatotoxicity. Give a glass of milk or water and employ supportive measures as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Biguanides and amidines, ATC Code: D08A C02
Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is inactive against bacterial spores except at elevated temperatures.
5.2 Pharmacokinetic properties
Because of its cationic nature, chlorhexidine binds strongly to skin mucosa and other tissues and is thus very poorly absorbed. There are, as a consequence, no general pharmacological studies on chlorhexidine available and its effects on internal organs are minimal. No detectable blood levels have been found in man following oral use and percutaneous absorption, if it occurs at all, is insignificant.
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.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Cetostearyl Alcohol Macrogol Cetostearyl Ether Isopropyl Alcohol Liquid Paraffin white Soft Paraffin Purified Water
6.2 Incompatibilities
Chlorhexidine is incompatible with soap and other anionic agents.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 30°C.
6.5 Nature and contents of container
250ml HDPE Bottle with a polypropylene cap
250ml HDPE shower bottle with a polypropylene cap
250ml HDPE soap dispenser pump pack
200ml polypropylene pump pack
50ml polypropylene pump pack
50ml HDPE sample pack with a polypropylene cap
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Genus Pharmaceuticals Limited Linthwaite,
Huddersfield,
HD7 5QH, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 06831/0242
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/01/2011
10 DATE OF REVISION OF THE TEXT
02/04/2015