Clorxil 5 mg/ml solution for cutaneous spray

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Package leaflet: Information for the user

Clorxil 5 mg/ml cutaneous spray solution

Chlorhexidine digluconate

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

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

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

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

4. Possible adverse effects

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

6. Contents of the pack and other information

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

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

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

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

Do not use Clorxil 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 Clorxil 5 mg/ml cutaneous spray solution.

• This medicine is for external use on the skin only. Do not ingest or inhale.
• Must not be applied in the ear or inside the mouth; in case of accidental contact, rinse immediately with plenty of water.
• Clorxil 5 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. In case of eye irritation, redness, pain, or visual disturbances, 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.
• The treated area must not be exposed to sunlight.
• Must not be used on large areas or under occlusive dressings (non-breathable dressings).
• Clothing that has been in contact with Clorxil 5 mg/ml must not be washed with bleach or other hypochlorites, as this will cause a brownish discoloration of the fabric. Instead, wash with household detergents based on sodium perborate.
• Use with caution in neonates, especially in premature infants. Clorxil 5 mg/ml may cause chemical burns on the skin.

Children

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

Use of Clorxil 5 mg/ml with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Simultaneous or consecutive use of other disinfectants should be avoided.

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Effects of this kind are not expected under the recommended conditions of use.

Clorxil 5 mg/ml cutaneous spray solution contains purified water.

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

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is to apply to the affected area once or twice daily. It should be applied directly after cleaning and drying the affected area.

No more than two applications of the product per day are recommended.

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

This medicine should not be used for longer than 7 consecutive days.

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience 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).

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 Medicinal Products: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clorxil 5 mg/ml cutaneous spray 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 stated on the label after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clorxil 5 mg/ml

Per ml of solution:

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

Appearance of the product and contents of the pack

Clear, colourless solution.

Available in bottles of 50 ml, 100 ml and 250 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

Telephone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Date of the most recent review of this leaflet: September 2022

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