Hibiscrub 40 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Hibiscrub 40 mg/ml cutaneous solution
chlorhexidine digluconate
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Hibiscrub is and what it is used for
- What you need to know before using Hibiscrub
- How to use Hibiscrub
- Possible adverse effects
- How to store Hibiscrub
- 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 and disinfectants.
It is indicated for use in adults and children as an antiseptic for surgical handwashing by healthcare personnel, and as a pre- and post-operative skin antiseptic.
2. What you need to know before using Hibiscrub
Do not use Hibiscrub
- if you are allergic to chlorhexidine digluconate or to any of the other ingredients of this medicine (listed in section 6).
- Hibiscrub contains soya oil. Do not use this medicine if you are allergic to peanuts or soya.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Hibiscrub.
- For external use on the skin only. Do not swallow.
- In case of accidental contact with ears, rinse immediately with plenty of water.
- Hibiscrub must not come into contact with the eyes due to the risk of visual injury. If contact occurs, wash eyes immediately and thoroughly with plenty of water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately. Serious cases of persistent corneal injury have been reported when similar products accidentally came into contact with the eyes during surgical procedures in patients under general anaesthesia (deep, painless unconsciousness).
- Do not use on deep or extensive wounds.
- Repeated applications, applications over large areas of skin, or use of dressings covering the treated area may increase the absorption of the product through the skin and lead to unwanted effects.
- Clothing that has been in contact with Hibiscrub should not be washed with bleach or other hypochlorites, as this may cause a brownish discoloration of the fabric. Instead, wash with household detergents based on sodium perborate.
- Use with caution in neonates, especially premature infants. Hibiscrub may cause chemical skin burns.
- Hibiscrub is flammable. Do not use near sources of ignition until it is completely dry.
Children and elderly patients
There are no special dosage recommendations for children or elderly patients. The normal adult dose is appropriate unless otherwise advised by a doctor.
Other medicines and Hibiscrub
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
The simultaneous or sequential use of several disinfectants should be avoided, except with other cationic compounds.
Hibiscrub must not be used in combination with, or after the use of, anionic soaps, acids, heavy metal salts, or iodine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There is no evidence of adverse effects on the fetus from the use of this medicine for handwashing during pregnancy and breastfeeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported after using this medicine.
Hibiscrub contains isopropyl alcohol and citrus fragrance
This medicine contains 40 mg of isopropyl alcohol per ml. Dryness, irritation, redness, or a burning sensation of the skin may occur. Allergic contact dermatitis or contact allergies are very rare.
This medicine contains fragrances including 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amyl cinnamaldehyde, Amyl cinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamaldehyde, Cinnamyl alcohol, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Oakmoss extract, and Moss extract. These may cause allergic reactions.
The fragrance also contains Bergamot oil containing bergapten, Soya oil, Ethanol, Methyl benzoate, Benzoic acid, Peru balsam, Formaldehyde, and Sodium lauryl sulfate.
Bergamot oil containing bergapten may increase sensitivity to UV light (natural or artificial daylight).
Ethanol may cause a 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 the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
Peru balsam may cause skin reactions.
Formaldehyde may cause local skin reactions (such as contact dermatitis).
Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medicines when applied to the same area.
3. How to use Hibiscrub
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For cutaneous use only.
Antiseptic handwash for surgery:
Wet hands and forearms, apply 5 ml of Hibiscrub and wash for 1 minute, cleaning under the nails with a brush; rinse and apply another 5 ml for 2 minutes; rinse and dry.
Antiseptic handwash for healthcare personnel:
Wet hands and forearms, apply 5 ml of Hibiscrub and wash for 1 minute; rinse and dry.
Pre-operative antiseptic skin wash:
Wash the entire body (bath or shower) at least twice, usually the day before and on the day of surgery, as follows: the day before surgery, wash from the face downwards using 25 ml of Hibiscrub, paying special attention to the areas around the nose, armpits, navel, groin, and perineum. Then rinse and repeat the wash with another 25 ml, including the hair. Finally, rinse and dry. Repeat this procedure the following day. For bedridden patients, apply the standard bed-bathing technique. Perform the conventional antiseptic washing of the surgical area with the patient in the operating room.
Post-operative antiseptic skin wash:
Starting on the third day after surgery, wash the entire body, excluding the surgical site, following the pre-operative antiseptic skin wash procedure.
If you use more Hibiscrub than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects:
Frequency not known (cannot be estimated from available data):
- Serious allergic reactions (anaphylactic reaction) which may cause difficulty breathing, weakness, collapse and death, and which may sometimes be preceded by swelling (particularly swelling of the lips, tongue and facial swelling) or rash.
- Chemical burns in neonates.
At the first signs of these reactions, inform your doctor, pharmacist or nurse and immediately discontinue the application of Hibiscrub.
Other possible adverse effects are:
- Frequency not known (cannot be estimated from available data): skin allergic disorders, skin inflammation (dermatitis), itching (pruritus), redness of the skin (erythema), eczema, rash, urticaria (urticarial wheals), skin irritation and blistering.
- Corneal lesion (injury to the surface of the eye) and permanent eye damage, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face and neck) in patients under general anaesthesia (induced painless deep sleep).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Hibiscrub
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after 'EXP'. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly discard unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Hibiscrub
- The active substance is chlorhexidine digluconate. Each ml contains 40 mg of chlorhexidine digluconate.
- The other components (excipients) are: PEG-7 glyceryl cocoate, glycerol (E422), D-gluconolactone, isopropyl alcohol, lauryldimethylamine oxide, citric perfume, poloxamer 237 (polyoxyethylene-polyoxypropylene copolymer), Ponceau 4R (E124), sodium hydroxide (E524) and purified water.
Appearance of the product and contents of the container
Hibiscrub is supplied in 500 ml HDPE bottles.
Marketing Authorization Holder
Mölnlycke Health Care AB
Entreprenörsstråket 21
SE-431 53 Mölndal
Sweden
Manufacturer
Société de Production Pharmaceutique et d'Hygiène (SPPH)
7 Impasse des Boussenots
21800 Quetigny
France
Local Representative
Mölnlycke Healthcare, S.L.
Date of the most recent review of this leaflet: June 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/