HIBIWASH 40 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet: information for the user

Hibiwash 40mg/ml cutaneous solution

chlorhexidine digluconate

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What is Hibiwash and what is it used for
2. What you need to know before using Hibiwash
3. How to use Hibiwash
4. Possible side effects
5. Storage of Hibiwash
6. Package contents and additional information

1. What is Hibiwash and what is it used for

Hibiwash contains the active ingredient chlorhexidine digluconate, which belongs to a group of medicines called antiseptics.

Hibiwash is used to disinfect hands and skin before or after an operation in adults and children to help prevent infections.

2. What you need to know before using Hibiwash

Do not use Hibiwash

• if you are allergic (hypersensitive) to chlorhexidine digluconate or any of the other components of this medicine (listed in section 6);
• in the eyes or in the middle ear. If this medicine accidentally enters your eyes or ears, rinse them immediately with plenty of water;
• on nerve tissue such as the brain and meninges (the membranes that surround the brain and spinal cord).

Warnings and precautions

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

• If you have a head or spinal cord injury or a perforated eardrum (a torn or perforated eardrum), your nurse, pharmacist, or doctor will decide if it is safe for you to use Hibiwash before an operation.
• Hibiwash should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, rinse immediately and abundantly with water. In case of irritation, redness, or eye pain, or visual disturbances, consult a doctor immediately. Serious cases of persistent corneal injury (eye surface injury) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).
• This medicine should not be used on deep and extensive wounds.
• Do not use too much of this medicine. Do not allow it to accumulate in skin folds, under the patient, or drip onto materials in direct contact with the patient.
• Do not inject the medicine.
• Hospital and domestic bleach (which contains chemicals called hypochlorites) may cause brown stains on tissues that have come into contact with this medicine.
• Do not use it with other soaps, as it may reduce the effectiveness of this medicine.
• This medicine is flammable (can catch fire). Do not use it with anything that may cause a fire until your skin is dry.
• This medicine should never be used to disinfect surgical instruments.

Children

Use with caution in newborn babies, especially premature babies, as this medicine may cause chemical burns.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, nurse, or pharmacist before using this medicine.

This medicine can be used during pregnancy. No risks are known with the use of this medicine during pregnancy or breastfeeding.

If you are breastfeeding, avoid using this medicine on the breast.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is nil.

3. How to use Hibiwash

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

This medicine should only be used on the skin.

Do not dilute Hibiwash before use.

Before an operation: surgical hand disinfection

Wash your hands and forearms with water. With 5 ml of this medicine, wash your hands and forearms for approximately one minute. Clean your nails with a brush or scraper. Rinse well. Repeat the wash a second time for about two minutes before rinsing well and drying your hands and forearms.

Antiseptic for skin and hands

Moisten the affected area with water and apply 5 ml of this medicine and wash for one minute. Rinse with plenty of water and dry.

Before the operation - body wash

Wash your entire body in the bathtub or shower at least twice, usually the day before the operation and the day of the operation.

How to wash the day before and the day of the operation:

• Wash your entire body with 25 ml of Hibiwash. Use it as soap. Start with the face and work your way down the body. Pay special attention to the skin around the nose, armpits, around the navel, between the legs, the groin area, and the buttocks.
• Then, rinse your entire body with water.
• Repeat the wash with another 25 ml of Hibiwash. This time, also wash your hair (use it as shampoo, but avoid getting it in your eyes).
• Then, rinse your entire body well with water and dry with a clean towel.

After the operation - body wash

Wash your entire body in the bathtub or shower, following the same method described above, avoiding the operated area. This is usually done on the third day after the operation.

Preoperative disinfection of the surgical site

Remove hair from the operated area only if necessary. Rub the skin with Hibiwash for a maximum of 2 minutes and then rub the area with sterile water. Remove the foam and dry.

If you use more Hibiwash than you should

If you or a child accidentally swallows the medicine, go to the nearest emergency department or contact your doctor immediately. Bring this leaflet and the remaining packaging so they know what has been swallowed.

If you have any further questions on the use of this medicine, ask your nurse, pharmacist, or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following serious side effects may occur, although their frequency is not known and cannot be estimated from the available data. At the first sign of any of these reactions, stop using Hibiwash immediately, consult a doctor as soon as possible, and go to the nearest hospital.

• Severe allergic reactions (hypersensitivity, including anaphylactic shock) - which can cause swelling of the lips, tongue, and face, skin rash, difficulty breathing, weakness, and collapse.

Other side effects

Frequency not known: cannot be estimated from the available data:

• Chemical burns in newborn babies (neonates).
• Skin allergic reactions that can appear immediately or 2 to 3 days or more after using the medicine and can cause skin swelling and redness, skin rash with itching (contact dermatitis), or itching, blisters, and eczema.
• Corneal injury (eye surface injury) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical procedures in the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hibiwash

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

Do not use this medicine after the expiration date stated on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Hibiwash composition

The active ingredient is chlorhexidine digluconate. 1 ml contains 40 mg of chlorhexidine digluconate.

The other ingredients are poloxamer, isopropyl alcohol, cocamidopropylamine oxide, glycerol (E422), macrogol-glycerol cocoate, D-gluconolactone, sodium hydroxide (for pH adjustment) (E524), and purified water.

Appearance of the product and package contents

Hibiwash is a clear, colorless, and slightly viscous solution that comes in white plastic bottles with closure caps containing 125 ml, 250 ml, 500 ml, or 5 liters (clinical packaging) of liquid.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Mölnlycke Health Care AB

Entreprenörsstråket 21

SE-431 53 Mölndal

Sweden

Societé de Production Pharmaceutique et d’Hygiène

7 Impasse des Boussenots

21800 Quetigny

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Molnlycke Health Care S.L.

Calle Quintanavides 17, Poligono Industrial Carretera De Burgos

28050 Madrid

Spain

Date of the last revision of this leaflet: June 2024