CLORXIL YELLOW 20 mg/ml CUTANEOUS SOLUTION

Introduction

PACKAGE LEAFLET

Package Leaflet:information for the user

Clorxil yellow 20 mg/ml cutaneous solution

chlorhexidine digluconate

Read all of this leaflet carefully before you start using this medicine,because it contains important information for you.

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

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

• You should consult a doctor if it worsens or does not improve.

Contents of the package leaflet

1. What Clorxil yellow is and what it is used for
2. What you need to know before you start using Clorxil yellow
3. How to use Clorxil yellow
4. Possible side effects

5 Conservation of Clorxil yellow

1. Contents of the pack and further information

1. What Clorxil yellow is and what it is used for

Clorxil yellow contains chlorhexidine digluconate, used as a skin antiseptic.

It is indicated as a skin antiseptic before performing invasive medical procedures, such as punctures, injections, catheter insertion, and preoperative field in surgeries, catheter maintenance, and surgical suturing in adults and children.

2. What you need to know before you start using Clorxil yellow

Do not use Clorxil yellow

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clorxil yellow

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

Do not use excessive amounts and avoid the solution accumulating in skin folds, under the patient, or soaking bedding or other materials in direct contact with the patient. Do not let the solution stagnate.

This medicine 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 medicine and contact your doctor as soon as possible (see section 4: "Possible side effects").

Avoid prolonged contact with the skin.

This medicine 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 mucous membranes of the body's entry points, the affected area should be washed immediately with plenty of water.
• Clorxil yellow 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 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 induced sleep).

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

This medicine 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 may occur with erythema, inflammation, itching, dry skin, and/or desquamation and localized pain in the administration area. At the first sign of any of these reactions, administration of this medicine should be stopped.

Children

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

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

Other medicines and Clorxil yellow

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

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,breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is not known whether chlorhexidine digluconate is excreted in breast milk. Since many medicines are excreted in breast milk, caution should be exercised when administering Clorxil yellow to breast-feeding women.

Driving and using machines

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

3. How to use Clorxil yellow

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 yellow 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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 at the administration site. 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 induced sleep).

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

-Dermatitis, eczema, urticaria, skin irritation, blisters

-Chemical burns in neonates.

Stop using Clorxil yellow 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Clorxil yellow

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

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.

No special storage conditions are required

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Clorxil yellow

Per ml of solution:

The active ingredient is: chlorhexidine digluconate 20 mg.

The other ingredients (excipients) are: purified water, natracol curcuma (polysorbate 80, propylene glycol, and curcuma (E-100)) and polysorbate 20.

Appearance of the product and contents of the pack

Transparent yellow solution presented in yellow HDPE/LDPE or HDPE plastic bottles with a white HDPE/LDPE stopper. It is presented in:

• Clinical packaging of 100 bottles of 20 ml.
• Clinical packaging of 50 bottles of 60 ml.
• Clinical packaging of 50 bottles of 100 ml.
• Clinical packaging 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)

Phone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Date of the last revision of thisleaflet: April 2023

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