Summary of Product Characteristics (SmPC) - Hibiscrub
1 NAME OF THE MEDICINAL PRODUCT
'Hibiscrub'
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 4% w/v
(incorporated as Chlorhexidine Gluconate Solution)
Excipient with known effect
Citrus perfume 0.5 mg/ml, fragrance with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amyl cinnamal, Amylcinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamal, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Oak moss and Tree moss. The fragrance also contains Bergamot oil (containing bergapten), Soya oil, Ethanol, Methyl benzoate, Benzoic acid, Balsam of Peru, Formaldehyde and Sodium laurilsulfate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Hibiscrub is an antimicrobial preparation for pre-operative surgical hand disinfection, antiseptic hand washing on the ward and pre-operative and post-operative skin antisepsis for patients undergoing elective surgery.
4.2 Posology and method of administration
For external use only.
Pre-operative surgical hand disinfection
Wet the hands and forearms, apply 5ml of Hibiscrub and wash for one minute cleaning the fingernails with a brush or scraper. Rinse, apply a further 5ml of Hibiscrub and continue washing for a further 2 minutes. Rinse thoroughly and dry.
Antiseptic handwash on the ward
Wet the hands and forearms, apply 5ml of Hibiscrub and wash for 1 minute. Rinse thoroughly and dry.
Pre-operative skin antisepsis for the patient
The patient washes his whole body in the bath or shower on at least 2 occasions, usually the day before and the day of operation as follows: The day before operation the patient washes with 25ml of Hibiscrub beginning with the face and working downwards paying particular attention to areas around the nose, axillae, umbilicus, groin and perineum. The body is then rinsed and the wash repeated with a further 25ml, this time including the hair. Finally the patient rinses his entire body thoroughly and dries on a clean towel. This procedure should be repeated the following day. Patients confined to bed can be washed with Hibiscrub using a standard bed-bath technique. Conventional disinfection of the operation site will then be performed when the patient is in theatre.
Post-operative skin antisepsis for the patients
The patient washes his whole body, excluding the operation wound, in the bath or shower usually on the third day after operation using the procedure described above.
Children and elderly patients
There are no special dosage recommendations for either elderly patients or children. The normal adult dose is appropriate unless recommended by the physician.
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).
Hibiscrub contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
4.4 Special warnings and precautions for use
Hibiscrub 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. Hibiscrub 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).
There have been reports where prolonged exposure of Chlorhexidine due to inadequate postoperative cleansing of the region or exposure to a large surface area (especially in young patients or patients with broken skin) may sensitise the patients. Re-exposure to chlorhexidine via surgical or nonsurgical chlorhexidine-containing products may contribute to delayed hypersensitivity reactions up to 28 days post exposure.
The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Hibiscrub, care must be taken to ensure no excess product is present prior to application of the dressing.
Hibiscrub is flammable. Do not use with electrocautery procedures or other ignition sources until dry.
For external use only. Avoid contact with the brain, meninges and middle ear. In patients with head or spinal injuries or perforated ear drum, the benefit of use in pre-operative preparation should be evaluated against the risk of contact.
Hibiscrub must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that Hibiscrub does not migrate beyond its intended application site into the eyes. Particular care should be taken in anaesthetised patients, who are unable to immediately report ocular exposure. If Hibiscrub solutions come into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist’s advice should be sought.
Do not inject or use in body cavities.
Isopropyl alcohol
Isopropyl alcohol may very rarely cause skin irritations such as erythema, dryness, contact allergies, burning sensation.
Citrus perfume
This medicine contains fragrance with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1- yl)-3-buten-2-one, Amyl cinnamal, Amylcinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamal, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxymethylpentyl-
cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Oak moss and Tree moss. These may cause allergic reactions.
The fragrance also contains Bergamot oil (containing bergapten), Soya oil, Ethanol, Methyl benzoate, Benzoic acid, Balsam of Peru, Formaldehyde and Sodium laurilsulfate.
Bergamot oil (containing bergapten) may increase sensitivity to UV light (natural and artificial sunlight).
Ethanol may cause burning sensation on damaged skin.
Benzoic acid, Benzyl benzoate and Methyl benzoate may cause local irritation. Benzoic acid, Benzyl benzoate and Methyl benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Balsam of Peru may cause skin reactions.
Formaldehyde may cause local skin reactions (e.g. contact dermatitis).
Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
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 Hibiscrub as a handwash 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
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).
Skin and subcutaneous tissue disorders:
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters. Delayed hypersensitivity including allergic contact dermatitis.
Immune system disorders:
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
Eye Disorder:
Frequency not known: Corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*
Injury, poisoning and procedural complications:
Frequency not known: Chemical burns in neonates.
Footnote: Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 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:
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
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
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antiseptics and disinfectants, ATC code: D08AC02
Mode of action – chlorhexidine has a wide range of antimicrobial activity. 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. Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found in man following oral use and percutaneous absorption, if it occurs at all, is insignificant.
5.2 Pharmacokinetic properties
Retention and uptake kinetics and factors influencing the pharmacokinetics. Chlorhexidine appears to be very poorly absorbed. No blood levels were detected during a 3-week simulated clinical use of Hibiscrub.
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
Poloxamer 237
Isopropyl alcohol
Lauryl dimethyl amine oxide
Glycerol
Macrogol-7 Glycerol Cocoate
Gluconolactone
Citrus perfume
Ponceau 4R (E124)
Purified water
Sodium hydroxide (for pH-adjustment)
6.2 Incompatibilities
Chlorhexidine is incompatible with soap and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics, which have previously been in contact with preparations containing chlorhexidine.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25ºC.
6.5 Nature and contents of container
HDPE bottles containing 125 ml, 250 ml, 500 ml and 5 litres.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
See section 4.4.
7 MARKETING AUTHORISATION HOLDER
Regent Medical Ltd
Medlock Street
Oldham
Lancashire
OL1 3HS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 22099/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21/04/1977 / 08/10/2003
10 DATE OF REVISION OF THE TEXT
01/10/2024