PATIENT INFORMATION LEAFLET

Patient Information Leaflet:Information for the User

Clorxil 5 mg/ml Topical Solution

chlorhexidine digluconate

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

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.What is Clorxil 5 mg/ml Topical Solution and what it is used for

2.What you need to knowbeforestarting touse Clorxil 5 mg/ml Topical Solution

3.How to use Clorxil 5 mg/ml Topical Solution

4.Possible side effects

5Storage of Clorxil 5 mg/ml Topical Solution

6.Contents of the pack and additional information

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

It is indicated for thedisinfection of wounds, wound drainage, ulcers, ostomies, mucous membranes, and urinary catheterization.

Do not use Chlorhexidine 5 mg/ml

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Chlorhexil 5 mg/ml skin solution.

• This medicine is for external use only on the skin. Do not ingest, inhale.
• Do not apply to the ear, or inside the mouth; in case of accidental contact, wash immediately with plenty of water.
• Chlorhexil 5 mg/ml skin solution 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 (injury to the surface of the eye) have been reported, which could require a corneal transplant when similar products have accidentally entered the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).

• Do not use for disinfecting puncture or injection sites, or for disinfecting surgical equipment.
• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not expose the treated area to the sun.
• Do not use on large areas, or with occlusive dressings (non-breathable).
• Clothes that have come into contact with Chlorhexil 5 mg/ml should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the fabric, but with domestic detergents based on sodium perborate.
• Use with caution in newborns, especially in premature babies. Chlorhexil 5 mg/ml can cause chemical burns on the skin.

Children

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

Use of Chlorhexil 5mg/ml with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Avoid simultaneous or successive use of other disinfectants.

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

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

Chlorhexil 5 mg/ml skin solution contains purified water.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

The recommended dose is to apply one or two times a day to the affected area. 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 should not be used for more than 7 consecutive days.

If you use more Clorxil 5 mg/ml topical solution 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 0420, indicating the medication and the amount ingested.

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

The most characteristic adverse effects are:

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

No special conditions are required for preservation.

Do not usethis medicationafter the expiration date that appears onthe labelafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacisthow to dispose ofthecontainers and medicines that you no longerneed. In this way, you will help protect the environment.

Composition of Clorxil 5 mg/ml

Per milliliter of solution:

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

Appearance of the product and contents of the packaging

Transparent and colorless solution.

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

Not all sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS BOHM, S.A.

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

28947 Fuenlabrada (Madrid)

Spain

Telephone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Date of the last review of thisleaflet: September 2022

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