CLORXIL 5 MG/ML CUTANEOUS SOLUTION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Package leaflet: information for the user

Clorxil 5 mg/ml cutaneous 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, consult 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, as it may 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 solution is and what it is used for
2. What you need to know before using Clorxil 5 mg/ml cutaneous solution
3. How to use Clorxil 5 mg/ml cutaneous solution
4. Possible side effects

5 Storage of Clorxil 5 mg/ml cutaneous solution

1. Contents of the pack and other information

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

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

It is indicated for the 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 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 using Clorxil 5 mg/ml cutaneous 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 cutaneous solution 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 require corneal transplantation, 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 equipment.
• Must not be used on deep or extensive wounds without consulting a doctor.
• The treated area must not be exposed to sunlight.
• Must not be used on large skin areas or under occlusive dressings (non-breathable).
• Clothing that has been in contact with Clorxil 5 mg/ml must not be washed with bleach or other hypochlorites, as this may cause brownish staining of fabrics. Instead, wash with domestic detergents based on sodium perchlorate.
• 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.

Concurrent or sequential use of other antiseptics 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 cleansing.

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 use of machines

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

Clorxil 5 mg/ml cutaneous solution contains purified water.

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

Follow exactly the instructions for administration of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is to apply to the affected area one or two times a day. Do not dilute. It should be applied directly after cleaning and drying the affected area.

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

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

It must not be used for longer than 7 consecutive days.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 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 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 5 mg/ml Cutaneous Solution

Keep this medicine out of 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Clorxil 5 mg/ml

Per each 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 10 ml, 50 ml, 100 ml, 250 ml and 500 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/)