Leaflet: information for the user

Hibiscrub 40 mg/ml topical solution

chlorhexidine digluconate

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Follow exactly the administration instructions for 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Hibiscrub belongs to a group of medicines called antiseptics and disinfectants.

It is indicated for adults and children as an antiseptic for hand washing in surgery and for healthcare personnel, and as a skin antiseptic pre and post-operatively.

No use Hibiscrub

• If you are allergic to chlorhexidine digluconate or any of the other components of this medication (listed in section 6).
• Hibiscrub contains soy oil. Do not use this medication in case of an allergy to peanuts or soy.

Advertencias y precauciones

Consult your doctor, pharmacist, or nurse before starting to use Hibiscrub.

• External use on the skin. Do not ingest.
• In case of accidental contact with the ears, wash immediately with plenty of water.
• Hibiscrub should not come into contact with the eyes due to the risk of visual injury. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of eye irritation, redness, or pain, or visual disturbances, consult a doctor immediately.
  Severe cases of persistent corneal injury have been reported when similar products have accidentally come into contact with the eyes during surgical interventions, in patients under general anesthesia (deep, painless sleep).
• Do not use in case of deep and extensive wounds.
• In case of repeated applications, applications on very extensive areas, or when using dressings that cover the affected area, it may favor the product penetrating through the skin and producing unwanted effects.
• Clothing that has come into contact with Hibiscrub should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.
• Use with caution in newborns, especially in premature children. Hibiscrub may cause chemical burns on the skin.
• Hibiscrub is flammable. Do not use it near ignition sources until it is dry.

Niños y pacientes de edad avanzada

No hay recomendaciones especiales de dosificación para niños y pacientes de edad avanzada. La dosis normal de adultos es apropiada a menos que se recomiende otra por el médico.

Otros medicamentos y Hibiscrub

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento.

Debe evitarse utilizar varios desinfectantes a la vez o de forma sucesiva, salvo con otros compuestos catiónicos.

No debe usarse en combinación ni después de la aplicación de jabones aniónicos, ácidos, sales de metales pesados y yodo.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

No existe evidencia de efectos adversos sobre el feto derivados del uso de este medicamento para el lavado de manos durante el embarazo y la lactancia.

Conducción y uso de máquinas

No se han descrito efectos sobre la capacidad de conducción y uso de máquinas tras el uso de este medicamento.

Hibiscrubcontiene alcohol isopropílico y perfume cítrico

This medication contains 40 mg of isopropyl alcohol in each ml. It may cause dryness, irritation, redness, or burning sensation on the skin. Contact dermatitis or allergic contact dermatitis are very rare.

This medication contains fragrances with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amilcinamaldehyde, Isopropyl amylcinamaldehyde, Anisyl alcohol, Benzyl alcohol, Benzoate of benzyl, Cinnamate of benzyl, Salicylate of benzyl, Cinnamaldehyde, Isopropyl cinnamyl alcohol, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Extract of red cedar moss, and Extract of red cedar moss. These may cause allergic reactions.

The fragrance also contains Bergamot oil containing bergapten, Soy 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).

Etanol may cause a burning sensation on injured 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 (yellow discoloration 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 medications when applied to the same area.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Skin use.

Surgical hand antisepsis:

Moisten hands and forearms, apply 5 ml of Hibiscrub and wash for 1 minute, cleaning nails with a brush, rinse and apply another 5 ml for 2 minutes; rinse and dry.

Antisepsis hand washing for healthcare personnel:

Moisten hands and forearms, apply 5 ml of Hibiscrub and wash for 1 minute; rinse and dry.

Pre-operative skin antisepsis:

Bathe the entire body (bath or shower) at least 2 times, usually the day before and the day of the operation as follows: the day before the operation, wash with 25 ml of Hibiscrub from the face downwards, paying attention to the surrounding areas of the nose, armpits, navel, groin, and perineum. Then rinse and repeat the wash with another 25 ml, including the hair. Finally, rinse and dry. This procedure will be repeated the next day. For bedridden patients, apply the usual bed washing technique. Perform the conventional antisepsis of the surgical area with the patient in the operating room.

Post-operative skin antisepsis:

From the third day of the surgical procedure, bathe the entire body, excluding the surgical area, following the pre-operative skin antisepsis washing procedure.

If you use more Hibiscrub than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Severe Adverse Effects:

Unknown frequency (cannot be estimated from available data):

• Severe allergic reactions (anaphylactic reaction) that may cause breathing difficulty, weakness, collapse, and death, and in some cases may be preceded by swelling (particularly lip, tongue, and facial swelling) or rash.
• Chemical burns in newborns.

At the first signs of these reactions, report to your doctor, pharmacist, or nurse and immediately discontinue the application of Hibiscrub..

Other possible adverse effects are:

• Unknown frequency (cannot be estimated from available data): skin allergic disorders, skin inflammation (dermatitis), itching (pruritus), skin redness (erythema), eczema, rash, urticaria (hives), skin irritation, and blisters.
• Corneal lesions (surface eye damage) and permanent eye damage, including permanent visual deterioration (following accidental eye exposure during surgical interventions on the head, face, and neck) in patients under general anesthesia (induced painless deep sleep).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle after 'CAD'. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hibiscrub

• The active ingredient is chlorhexidine digluconate. Each ml contains 40 mg of chlorhexidine digluconate.
• The other components (excipients) are: PEG-7-glyceril cocoate, glycerol (E422), D-gluconolactone, isopropyl alcohol, laurildimethylamine oxide, citrus perfume, poloxamer 237 (copolymer of polyoxyethylene-polyoxypropylene), Ponceau 4R (E124), sodium hydroxide (E524), and purified water.

Appearance of the product and contents of the packaging

Hibiscrub is presented in 500 ml HPDE bottles.

Marketing Authorization Holder

Mölnlycke Health Care AB

Entreprenörsstråket 21

SE-431 53 Mölndal

Sweden

Responsible for Manufacturing

Société de Production Pharmaceutique et d'Hygiène (SPPH)

7 Impasse des Boussenots

21800 Quetigny

France

Local Representative

Mölnlycke Healthcare, S.L.

Last review date of this leaflet: June 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/