PATIENT INFORMATION LEAFLET

Clorxil 10 mg/ml solution for inhalation

Clorhexidina digluconate

Clorxil 10 mg/ml contains chlorhexidine, which is a topical antiseptic.

It is indicated for skin disinfection, erosions, superficial small wounds, minor burns, and abrasions.

Do not use Chlorhexidine 10 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

• This medicine is for external use only on the skin. Do not ingest or inhale.
• Do not apply to the ear, or inside the mouth; in case of accidental contact, wash immediately with plenty of water.
• Chlorhexidine 10 mg/ml should not come into contact with the eyes due to the risk of eye injury. If it comes into contact with the eyes, wash immediately and abundantly with water. If irritation, redness, or pain in the eyes, or visual disturbances occur, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which may require a corneal transplant when similar products have accidentally come into contact with the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).

• Do not use for the disinfection of puncture or injection sites, or for the disinfection of surgical equipment.
• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not use on large areas, or with occlusive dressings (non-breathable).
• Clothing that has come into contact with Chlorhexidine 10 mg/ml should not be washed with bleach or other hypochlorites, as this would cause a dark discoloration of the fabric, but with domestic detergents based on sodium perborate.
• Use with caution in newborns, especially in premature infants. Chlorhexidine 10 mg/ml may cause chemical burns on the skin.

Use in Children

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

Use of Chlorhexidine with Other Medicines

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

Simultaneous or successive use of other disinfectants should be avoided.

The product is incompatible with anionic derivatives (soaps) and should be rinsed thoroughly after cleaning the skin.

Pregnancy and Breastfeeding

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

The consumption of medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and Operating Machinery

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

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

This medication must be administered by skin spray directly onto the wounds or affected areas after cleaning and drying the wound.

It is recommended not to use more than two applications per day 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 than the recommended Clorxil 10 mg/ml, you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91 5620420, indicating the medication and the amount ingested.

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

The characteristic adverse effects are:

• Risk of systemic effects
• 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 eye surface) and permanent eye injury, including permanent visual impairment (following accidental eye exposure during surgical procedures in the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 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 the bottle perfectly closed to protect it from light.

Store below 25°C.

Keep this medication out of sight and reach of children.

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

Medicines should not be thrown away through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Clorxil 10mg/ml

For each ml of solution:

The active ingredient is: Chlorhexidine digluconate 10 mg.

The other components (excipients) are: Purified water.

Appearance of the product and contents of the packaging

Clear, transparent solution.

It is presented in:

• 1 bottle of 50 ml
• 1 bottle of 100 ml
• 1 bottle of 250 ml
• 1 clinical pack of 50 bottles of 100 ml
• 1 clinical pack of 50 bottles of 250 ml

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Bohm, S.A.

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

28947 Fuenlabrada. (Madrid).

91 642 18 18

Local representative:

Laboratorios Hartmann, S.A.

C/ Carrasco i Formiguera, 48.

08302 Mataró (Barcelona)

Date of the last revision of this leaflet: January 2015

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