CLORXIL WITH ALCOHOL ORANGE 20 mg/mL + 0.49 mL/mL CUTANEOUS SOLUTION

Introduction

Leaflet: information for the user

Clorxil with alcohol orange 20 mg/ml + 0.49 ml/ml cutaneous solution

chlorhexidine digluconate / ethanol

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or nurse, even if they are side effects that do not appear in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

Contents of the leaflet

1. What Clorxil with alcohol orange is and what it is used for
2. What you need to know before starting to use Clorxil with alcohol orange
3. How to use Clorxil with alcohol orange
4. Possible side effects

5 Conservation of Clorxil with alcohol orange

1. Package contents and additional information

1. What Clorxil with alcohol orange is and what it is used for

Clorxil with alcohol orange contains chlorhexidine digluconate and ethanol, used as a skin antiseptic.

It is indicated as a skin antiseptic prior to extractions, injections, insertion and maintenance of catheters, surgical sutures, perilesional skin, punctures, and surgical field in adults and children.

2. What you need to know before starting to use Clorxil with alcohol orange

Do not use Clorxil with alcohol orange

If you are allergic (hypersensitive) to chlorhexidine digluconate, ethanol, or any of the other components of this medication (included in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clorxil with alcohol.

This medication is for external use only. Do not ingest or inhale.

The solution is flammable.

The risk of fire is high when using an ignition source (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with a combustion source (such as cloths, towels...) and an oxidizing agent (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

• Do not use electrocauterization procedures or other ignition sources until the skin is completely dry.
• Remove any soaked material, gauzes, or gowns before starting the intervention.
• Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient. Do not let the solution stagnate.
• When applying an occlusive dressing to areas previously exposed to Clorxil with alcohol orange, be especially careful not to have excess product before applying the dressing.
• Reduce the oxygen supply or any other oxidizing agent to the minimum necessary. Those procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizing agent put the patient at risk of suffering a surgical fire.

This medication may, in rare cases, cause severe allergic reactions leading to a decrease in blood pressure and even loss of consciousness. The first symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using this medication and contact your doctor as soon as possible (see section 4: "Possible side effects").

Avoid prolonged contact with the skin.

This medication should not be applied:

• Near sensitive areas (mucous membranes), as it may cause irritation, pain, redness, and chemical burns. In case of accidental contact with the eyes or mucous membranes of the body's entry points, the affected area should be rinsed immediately with plenty of water.
• Clorxil with alcohol orange should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, rinse 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 could 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).

• On open wounds.
• On the inner part of the ear (middle ear).
• In direct contact with neural tissue (e.g., brain and spinal cord).
• Clothes that have come into contact with Clorxil with alcohol should not be washed with bleach or other hypochlorites, as this would produce a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.

This medication should only be applied gently to the skin. If the solution is applied too vigorously to fragile or sensitive skin, or after repeated use, a local skin reaction with erythema, inflammation, itching, dry skin, and/or peeling and localized pain in the administration area may occur. In the event of the first sign of any of these reactions, administration of this medication should be stopped.

Children

Use with caution in neonates, especially in premature babies. Clorxil with alcohol can cause chemical burns to the skin.

This medication should only be used under medical prescription in children under 30 months.

Other medications and Clorxil with alcohol orange

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

Inform your doctor or nurse if you have recently been administered a vaccine or an injection for a skin test (epicutaneous tests to detect allergies).

The simultaneous or successive use of other antiseptics should be avoided to minimize the risk of possible interference between them.

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

Pregnancy, breastfeeding, and fertility

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

It is unknown whether chlorhexidine digluconate or ethanol is excreted in breast milk. Since many medications are excreted in breast milk, caution should be exercised when administering Clorxil with alcohol orange to breastfeeding women.

Driving and using machines

Clorxil with alcohol orange does not alter the ability to drive or operate machines.

3. How to use Clorxil with alcohol orange

Apply the product gently to the area of skin that needs to be prepared. Apply as many times as necessary depending on the medical procedure. Do not dilute.

The product should be applied directly to the area to be treated and allowed to dry before any procedure.

In case of doubt, ask your doctor or nurse.

If you use more Clorxil with alcohol orange than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 0420, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The very rare side effects (less than 1 in 10,000 people) observed in the skin and subcutaneous tissue are:

Skin irritation, including: erythema, rash, urticaria, pruritus, and blisters or vesicles in the administration area. Other local symptoms may be: burning sensation on the skin, pain, and inflammation.

Other side effects with an unknown frequency (cannot be estimated from the available data) are:

-Allergic reactions, including anaphylactic shock.

-Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

-Pain, hyperemia, and chemical burns in cases of accidental contact.

-Dermatitis, eczema, urticaria, skin irritation, blisters.

-Chemical burns in neonates.

Stop using Clorxil and seek immediate medical attention if you experience any of the following reactions: swelling of the face, lips, tongue, or throat; red and itchy skin rash; wheezing or difficulty breathing; feeling of fainting and dizziness; strange metallic taste in the mouth; collapse. You may be having an allergic reaction.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Clorxil with alcohol orange

This medication is flammable. Avoid exposing the bottle and its contents to open flames during use, storage, and disposal of the product.

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

Keep the bottle perfectly closed to protect it from light.

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

Medications should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Clorxil with alcohol orange cutaneous solution

The active ingredients are: chlorhexidine digluconate and ethanol

The other components (excipients) are: glycerin, carmoisine, azorubine (E-122)

natracol curcumin (polysorbate 80, propylene glycol, and curcumin (E-100)) and purified water

Each ml of solution contains: 20 mg of chlorhexidine digluconate and 0.49 ml of ethanol.

Appearance of the product and package contentsTransparent reddish solution presented in orange plastic bottles (HDPE/LDPE or HDPE) with a white HDPE/LDPE stopper.

It is presented in:

• Clinical packaging of 100 bottles of 10 ml.

• Clinical packaging of 100 bottles of 20 ml
• Clinical packaging of 50 bottles of 100 ml
• Clinical packaging of 50 bottles of 250 ml.

• Clinical packaging of 20 bottles of 500 ml.

Marketing authorization holder and manufacturer

LABORATORIOS BOHM, S.A.

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

28947 Fuenlabrada (Madrid)

Phone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Date of the last revision of this leaflet: May 2024

Other sources of information

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