CLORXIL 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

LEAFLET: INFORMATION FOR THE USER

Clorxil 10 mg/ml solution for cutaneous spraying

Chlorhexidine digluconate

Contents of the leaflet:

1. What Clorxil 10 mg/ml solution for cutaneous spraying is and what it is used for.
2. What you need to know before starting to use Clorxil 10 mg/ml solution for cutaneous spraying.
3. How to use Clorxil 10 mg/ml solution for cutaneous spraying.
4. Possible side effects.
5. Storage of Clorxil 10 mg/ml solution for cutaneous spraying.
6. Contents of the package and additional information.

1. What Clorxil 10 mg/ml solution for cutaneous spraying is and what it is used for

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

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

2. What you need to know before using Clorxil 10 mg/ml solution for cutaneous spraying

Do not use Clorxil 10 mg/ml

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

Warnings and precautions

• This medication is for external use only on the skin. Do not ingest or inhale.
• Do not apply it to the ear or inside the mouth; in case of accidental contact, wash immediately with plenty of water.
• Clorxil 10 mg/ml should 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 sleep induced without pain).

• Do not use it for the disinfection of puncture or injection sites, or for the disinfection of surgical equipment.
• Do not use it in case of deep and extensive wounds without consulting a doctor.
• Do not use it on large areas, or with occlusive dressings (non-permeable).
• Clothes that have come into contact with Clorxil 10 mg/ml should not be washed with bleach or other hypochlorites, as this would cause a dark discoloration of the tissues, but with domestic detergents based on sodium perchlorate.
• Use with caution in neonates, especially in premature babies. Clorxil 10 mg/ml can cause chemical burns to the skin.

Use in children

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

Use of Clorxil with other medications

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

Avoid simultaneous or successive use of other disinfectants.

The product is incompatible with anionic derivatives (soaps), so the skin should be rinsed well after cleaning.

Pregnancy and breastfeeding

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

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

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

3. How to use Clorxil 10 mg/ml solution for cutaneous spraying

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

This medication should be administered by spraying it directly onto the wounds or affected areas after cleaning and drying the wound.

It is recommended not to use more than two applications of the product per day.

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

Do not use it for more than 7 consecutive days.

If you use more Clorxil 10 mg/ml than you should

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Clorxil 10 mg/ml solution for cutaneous spraying

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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Clorxil 10mg/ml

Per 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 package

Cutaneous solution, transparent.

It is presented:

• 1 bottle of 50 ml
• 1 bottle of 100 ml
• 1 bottle of 250 ml
• Clinical package of 50 bottles of 100 ml
• Clinical package of 50 bottles of 250 ml

Marketing authorization holder and manufacturer

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

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