Clorxil 20 mg/ml solution for cutaneous spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Clorxil 20 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.
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Keep this leaflet, as you may need to read it again.
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If you need advice or further information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve.
Contents of this leaflet
- What Clorxil is and what it is used for
- What you need to know before using Clorxil
- How to use Clorxil
- Possible side effects
- How to store Clorxil
- Contents of the pack and other information
1. What Clorxil is and what it is used for
Clorxil contains chlorhexidine digluconate, which is used as a skin antiseptic.
It is indicated as a skin antiseptic prior to invasive medical procedures such as punctures, injections, catheter insertion, and preoperative surgical fields, as well as for catheter and surgical suture maintenance in adults and children.
2. What you need to know before using Clorxil
Do not use Clorxil
- 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
Consult your doctor or pharmacist before starting to use Clorxil.
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 bed sheets or other materials in direct contact with the patient. Do not allow the solution to pool.
This medicine may, in rare cases, cause severe allergic reactions leading to a drop in blood pressure and even loss of consciousness. Initial symptoms of a severe allergic reaction may include skin rash or asthma. If you notice these symptoms, stop using this medicine immediately 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 entry sites, immediately rinse the affected area thoroughly with water.
- Clorxil must not come into contact with the eyes due to the risk of visual damage. If contact occurs, immediately and thoroughly rinse the eyes 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 may even require a corneal transplant, when similar products accidentally came 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 come into contact with Clorxil 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 applied gently 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, inflammation, itching, dry and/or scaly skin, and localized pain at the application site. If any of these reactions appear, discontinue use of this medicine immediately.
Children
Use with caution in neonates, especially in premature infants. Clorxil may cause chemical burns to the skin.
This medicine should only be used under medical prescription in children under 30 months of age.
Other medicines and Clorxil
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Inform your doctor or nurse if you have recently received a vaccine or a skin test injection (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 to breastfeeding women.
Driving and using machines
Clorxil does not affect the ability to drive or operate machinery.
3. How to use Clorxil
Gently apply the product onto the area of skin that needs to be prepared. Spray as many times as necessary, depending on the medical procedure. Each spray delivers a volume of 130 microliters. 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 than you should
In case of overdose or accidental ingestion, immediately consult 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 can cause adverse effects, although not everyone experiences 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 available data) are:
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Allergic reactions including anaphylactic shock.
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Corneal lesion (injury to the surface of the eye) and permanent eye damage, 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 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Clorxil
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 must 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 container and other information
Composition of Clorxil
Per ml of solution:
The active substance is: chlorhexidine digluconate 20 mg.
The excipient is purified water.
Each ml of solution contains: 20 mg of chlorhexidine digluconate.
Appearance of the product and contents of the container
A clear, colourless solution supplied in white HDPE plastic bottles with a white PP/PE spray pump dispenser. It is available in the following pack sizes:
- Clinical pack of 50 bottles of 60 ml
- Clinical pack of 50 bottles of 100 ml
- Clinical pack of 50 bottles of 250 ml
- Pack of 1 bottle of 100 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 revision of this product information:
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/)