Clorxil Yellow 20 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
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.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or does not improve.
Contents of the leaflet
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What Clorxil yellow is and what it is used for
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What you need to know before using Clorxil yellow
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How to use Clorxil yellow
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Possible adverse effects
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Storage of Clorxil yellow
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Contents of the pack and other information
1. What Clorxil yellow is and what it is used for
Clorxil yellow contains chlorhexidine digluconate, which is used as a skin antiseptic.
It is indicated as a skin antiseptic prior to performing invasive medical procedures such as punctures, injections, catheter insertion, and preoperative surgical site preparation, as well as for catheter care and surgical suture in adults and children.
2. What you need to know before using Clorxil yellow
Do not use Clorxil yellow
- If you are allergic (hypersensitive) to chlorhexidine digluconate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Clorxil yellow.
This medicine is for external use only. Do not ingest or inhale.
Do not use excessive amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking into bed sheets or other materials in direct contact with the patient. Do not allow the solution to pool.
This medicine may, rarely, cause severe allergic reactions leading to a drop in blood pressure and even loss of consciousness. Early signs of a severe allergic reaction may include 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 must not be applied:
- Near sensitive areas (mucous membranes), as it may cause irritation, pain, redness, and chemical burns. In case of accidental contact with mucous membranes at body orifices, immediately rinse the affected area thoroughly with water.
- Clorxil yellow must not come into contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse the eyes 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 may require corneal transplantation, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (pain-free induced deep 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 been in contact with Clorxil yellow should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the fabric. Instead, wash with domestic detergents based on sodium perborate.
This medicine should only be gently applied to the skin. If the solution is applied too vigorously on fragile or sensitive skin, or after repeated use, a local skin reaction may occur, including erythema, swelling, itching, dry and/or scaly skin, and localized pain at the site of application. At the first sign of any of these reactions, discontinue use of this medicine.
Children
Use with caution in neonates, especially in premature infants. Clorxil yellow may cause chemical burns on the skin.
This medicine should only be used under medical prescription in children under 30 months of age.
Other medicines and Clorxil yellow
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Inform your doctor or nurse if you have recently received a vaccine or an injection for a skin test (epicutaneous tests to detect allergies).
Concurrent or sequential use of other antiseptics should be avoided to minimize the risk of possible interactions between them.
The product is incompatible with anionic derivatives (soaps); 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.
It is unknown 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 breastfeeding women.
Driving and using machines
Clorxil does not affect the ability to drive or operate machinery.
3. How to use Clorxil yellow
Gently apply the product 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.
If in doubt, consult your doctor or nurse.
If you use more Clorxil yellow than you should
In case of overdose or accidental ingestion, immediately contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 0420, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Very rare adverse effects (less than 1 in 10,000 people) observed on the skin and subcutaneous tissue are:
Skin irritation, including: erythema, rash, urticaria, pruritus, and blisters or vesicles at the application site. Other local symptoms may include: burning sensation on the skin, pain, and inflammation.
Other adverse effects with unknown frequency (cannot be estimated from the available data) are:
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Allergic reactions including anaphylactic shock.
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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).
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Pain, hyperemia, and chemical burns in cases of accidental contact.
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Dermatitis, eczema, urticaria, skin irritation, blisters.
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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, itchy rash; wheezing or difficulty breathing; feeling faint or dizzy; unusual metallic taste in the mouth; collapse. You may be experiencing an allergic reaction.
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 via the Spanish Pharmacovigilance System for Human Medicinal Products at http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage 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 medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Clorxil yellow
Per each ml of solution:
The active substance is: chlorhexidine digluconate 20 mg.
The other components (excipients) are: purified water, natracol curcumin (polysorbate 80, propylene glycol and curcumin (E-100)) and polysorbate 20.
Appearance of the product and contents of the container
Yellow transparent solution supplied in yellow HDPE/LDPE or HDPE plastic bottles with white HDPE/LDPE screw caps. It is available in:
- Clinical pack containing 100 bottles of 20 ml.
- Clinical pack containing 50 bottles of 60 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)
Telephone: 91 642 18 18
Fax: 91 642 0572
Email: [email protected]
Date of the most recent review of this leaflet: April 2023
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/)