Hibiscrub 4.0% w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine gluconate

Available from:

Regent Medical Overseas Limited

ATC code:

D08AC; D08AC02

INN (International Name):

Chlorhexidine gluconate

Dosage:

4.0 percent weight/volume

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Biguanides and amidines; chlorhexidine

Authorization status:

Marketed

Authorization date:

1980-05-30

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HIBISCRUB® 4% W/V CUTANEOUS SOLUTION
Chlorhexidine gluconate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse
have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hibiscrub is and what it is used for
2.
What you need to know before you use Hibiscrub
3.
How to use Hibiscrub
4.
Possible side effects
5.
How to store Hibiscrub
6.
Contents of the pack and other information
1.
WHAT HIBISCRUB IS AND WHAT IT IS USED FOR
Hibiscrub belongs to a group of medicines called antiseptics. This
means that it helps to prevent
infections by killing germs on the skin.
Hibiscrub cutaneous solution contains the active ingredient
chlorhexidine gluconate 4% w/v
(40 mg/ml), which has antimicrobial properties.
Hibiscrub is used to disinfect the hands and skin prior to or after an
operation or clean procedure (pre-
and post-operative hand and skin disinfection / antisepsis).
Hibiscrub is also used to disinfect hands after handling infected
materials (antiseptic handwashing).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HIBISCRUB
DO NOT USE HIBISCRUB
-
if you are allergic (hypersensitive) to chlorhexidine gluconate or any
of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Hibiscrub.
-
Avoid contact with the eyes, brain, meninges (the membranes
surrounding the brain and spinal
cord) and middle ear. If Hibiscrub comes into contact with the eyes,
wash out immediately and
thoroughly with water.
-
In patients with head or spinal injuries or a perforated ear drum (

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2019
CRN009FLX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hibiscrub 4.0% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 40 mg/ml (4.0% w/v).
(incorporated as Chlorhexidine Digluconate Solution).
Excipient with known effect
Herbacol 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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution
A clear or slightly opalescent red aqueous detergent antiseptic
solution with a characteristic citrus odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
'Hibiscrub' is an antimicrobial preparation for pre-operative surgical
hand disinfection, antiseptic hand washing on the ward,
pre-operative skin preparation for patients undergoing elective
surgery and post-operative skin antisepsis for the patient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Pre-operative surgical hand disinfection
Wet the hands and forearms, apply 5 ml of 'Hibiscrub' and wash for one
minute cleaning the fingernails with a brush or
scraper.Rinse, apply a further 5 ml of 'Hibiscrub' and continue
washing for a further two minutes. Rinse thoroughly and dry.
Antiseptic hand wash on the ward
Wet the hands and forearms, apply 5 ml of 'Hibiscrub' and wash for one
minute.Rinse thoroughly and dry.
Pre-operative skin preparation for patients undergoing elective
surgery
This involves two stages:
First phase(e.g. on ward): The patient may prepare himself by
undertaking whole-body disinfection with ‘Hibiscrub’.
On at least two occasions, usually the