CLORXIL 10 MG/ML SOLUTION FOR CUTANEOUS SPRAY

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clorxil 10 mg/ml cutaneous spray solution

Chlorhexidine digluconate

Package leaflet contents:

1. What Clorxil 10 mg/ml cutaneous spray solution is and what it is used for.
2. What you need to know before using Clorxil 10 mg/ml cutaneous spray solution.
3. How to use Clorxil 10 mg/ml cutaneous spray solution.
4. Possible side effects.
5. How to store Clorxil 10 mg/ml cutaneous spray solution.
6. Contents of the pack and other information.

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

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

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

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

Do not use Clorxil 10 mg/ml

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

Warnings and precautions

• This medicine is for external use on the skin only. Do not ingest or inhale.
• Must not be applied to the ear or inside the mouth; in case of accidental contact, rinse immediately with plenty of water.
• Clorxil 10 mg/ml must not come into contact with the eyes due to the risk of visual injury. If contact occurs, rinse immediately and thoroughly with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.

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

• Must not be used for disinfection of puncture or injection sites, or for disinfection of surgical instruments.
• Must not be used for deep or extensive wounds without consulting a doctor.
• Do not use on large skin areas or under occlusive dressings (non-breathable).
• Clothing that has been in contact with Clorxil 10 mg/ml must not be washed with bleach or other hypochlorites, as this may cause a dark discoloration of the fabric. Instead, wash with domestic detergents based on sodium perborate.
• Use with caution in neonates, especially in premature infants. Clorxil 10 mg/ml may cause chemical burns on the skin.

Use in children

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

Use of Clorxil with other medicines

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

Concurrent or sequential use with other disinfectants should be avoided.

The product is incompatible with anionic derivatives (soaps); therefore, the skin must be thoroughly rinsed 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 medicine.

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

Driving and use of machinery

No effects of this kind are expected under the recommended conditions of use.

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or nurse. If in doubt, consult your doctor or pharmacist.

This medicine should be administered by cutaneous spray directly onto wounds or affected areas after cleaning and drying the wound.

The use of more than two applications per day is not recommended.

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

Do not use for more than 7 consecutive days.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 5620420, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most characteristic adverse effects are:

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

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clorxil 10 mg/ml cutaneous spray solution

Keep the bottle tightly closed to protect it from light.

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clorxil 10 mg/ml

Each ml of solution contains:

The active substance is: Chlorhexidine digluconate 10 mg.

The other components (excipients) are: Purified water.

Appearance of the medicinal product and contents of the container

Cutaneous solution, transparent.

Available as:

• 1 bottle of 50 ml
• 1 bottle of 100 ml
• 1 bottle of 250 ml
• Clinical pack containing 50 bottles of 100 ml
• Clinical pack containing 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 most recent revision of this package leaflet: January 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es