CLORXIL 5 mg/ml CUTANEOUS SOLUTION

Introduction

PACKAGE LEAFLET

Package Leaflet:information for the user

Clorxil 5 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.

• Keep this leaflet, you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Clorxil 5 mg/ml cutaneous solution is and what it is used for
2. What you need to know before you start using Clorxil 5 mg/ml cutaneous solution
3. How to use Clorxil 5 mg/ml cutaneous solution
4. Possible side effects

5 Conservation of Clorxil 5 mg/ml cutaneous solution

1. Contents of the pack and further information

1. What Clorxil 5 mg/ml cutaneous solution is and what it is used for and what it is used for

Clorxil 5mg/ml contains chlorhexidine, which is a cutaneous antiseptic.

It is indicated for the disinfection of wounds, wound drainage, ulcers, ostomies, mucous membranes, and bladder catheterization.

2. What you need to know before you start using Clorxil 5 mg/ml cutaneous solution

Do not use Clorxil 5 mg/ml

• If you are allergic (hypersensitive) to chlorhexidine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clorxil 5 mg/ml cutaneous solution.

• This medicine is for external use on the skin only. Do not ingest or inhale.
• It must not be applied to the ear or inside the mouth; in case of accidental contact, wash immediately with plenty of water.
• Clorxil 5 mg/ml cutaneous solution must not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of irritation, redness, or pain in the eyes, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) that may require a corneal transplant 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 induced).

• It must not be used for the disinfection of puncture or injection sites, or for the disinfection of surgical equipment.
• It must not be used in the case of deep and extensive wounds without consulting a doctor.
• The treated area must not be exposed to the sun.
• It must not be used on extensive areas or with occlusive dressings (non-permeable).
• Clothes that have come into contact with Clorxil 5 mg/ml must not be washed with bleach or other hypochlorites, as this would cause a brown discoloration of the tissues, but with domestic detergents based on sodium perchlorate.
• Use with caution in neonates, especially in premature babies. Clorxil 5 mg/ml can cause chemical burns to the skin.

Children

Do not use in children under 30 months without consulting a doctor.

Use of Clorxil 5mg/mlwithother medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The simultaneous or successive use of other disinfectants should be avoided.

The product is incompatible with anionic derivatives (soaps), acids, heavy metal salts, and iodine, so the skin should be rinsed well after cleaning.

Pregnancy,breast-feeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

No effects are expected in this regard under the indicated conditions of use.

Clorxil 5 mg/ml cutaneous solution contains purified water.

3. How to use Clorxil 5 mg/ml cutaneous solution

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is to apply to the affected area once or twice a day. Do not dilute. It should be applied directly after cleaning and drying the affected area.

It is recommended not to perform more than two daily applications of the product.

If symptoms worsen or persist after 7 days, consult your doctor.

It must not be used for more than 7 consecutive days.

If you use more Clorxil 5 mg/ml cutaneous solution than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 0420, indicating the medicine and the amount ingested.

4. Possible side effects

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

The most characteristic side effects are:

• Risk of systemic effects.
• Some isolated cases of hypersensitivity to chlorhexidine have been observed.
• Possibility of allergic eczema and photosensitization (sensitivity to sunlight of the treated area).

Other possible side effects, for which the frequency is unknown, are:

• Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep, painless sleep induced).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Clorxil 5 mg/ml cutaneous solution

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the label after CAD. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Clorxil 5 mg/ml

Per ml of solution:

• The active ingredient is: Chlorhexidine Digluconate 5 mg.
• The other ingredients (excipients) are: Purified Water.

Appearance of the product and contents of the pack

Transparent and colorless solution.

It is presented in bottles of 10 ml, 50 ml, 100 ml, 250 ml, and 500 ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS BOHM, S.A.

C/ Molinaseca 23-25. Polígono Industrial Cobo Calleja.

28947 Fuenlabrada (Madrid)

Spain

Phone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Date of last revision of thisleaflet: September 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/)