Summary of Product Characteristics (SmPC) - Hibitane Obstetric cream
1 NAME OF THE MEDICINAL PRODUCT
Hibitane Obstetric Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 1% w/w
(Incorporated as Chlorhexidine Gluconate Solution Ph. Eur.5.0 v/w)
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
‘Hibitane’ Obstetric Cream is an antimicrobial preparation for use as an antiseptic and lubricant in obstetric and gynaecological practice.
4.2 Posology and method of administration
Adults
Apply liberally to the skin around the vulva and perineum of the patient, and to the gloved hands of the midwife or doctor.
Elderly and Children
There are no special dosage recommendations for either elderly patients or children.
4.3 Contraindications
‘Hibitane’ preparations are contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine. However, such reactions are extremely rare.
4.4 Special warnings and precautions for use
For topical application only. Keep out of the eyes and ears and avoid contact with the brain and meninges.
Local stinging and/or chemical burns have been reported following off-label use of gauze packs soaked in Hibitane Obstetric Cream and left intra-vaginally for prolonged periods.
4.5 Interaction with other medicinal products and other forms of interaction
See section 6.2.
4.6 Fertility, pregnancy and lactation
There is no evidence of any adverse effects on the foetus arising from the use of ‘Hibitane’ Obstetric Cream 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
Irritative skin reactions can occasionally occur. Generalised allergic reactions to chlorhexidine including anaphylaxis have also been reported but are extremely rare.
Individual cases of local stinging and/or chemical burns have been reported following off-label use of gauze packs soaked in Hibitane Obstetric Cream and left intra-vaginally for prolonged periods.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
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
5.1 Pharmacodynamic properties
Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeast, 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetostearyl Alcohol
Cetostearyl Alcohol/Ethylene Oxide Condensate
Isopropyl Alcohol
Linalyl Acetate
Liquid Paraffin
White Soft Paraffin
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
3 years
6.4 Special precautions for storage
Store below 30ºC
6.5 Nature and contents of container
White HDPE bottle containing either 50 ml or 250 ml.
Pack sizes: 1 x 50 ml, 10 x 50 ml, 1 x 250 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Use undiluted
7 MARKETING AUTHORISATION HOLDER
Derma UK Ltd
The Toffee Factory
Lower Steenbergs Yard, Quayside
Ouseburn, Walker Rd
Newcastle upon Tyne
Tyne and Wear NE1 2DF
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 19876/0009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/08/1998
10 DATE OF REVISION OF THE TEXT
02/07/2021