Clorhexlan 20 mg/ml solution for cutaneous spray
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Clorhexlan 20 mg/ml solution for cutaneous spray
chlorhexidine digluconate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your doctor or nurse.
- If you experience adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Clorhexlan is and what it is used for
- What you need to know before using Clorhexlan
- How to use Clorhexlan
- Possible adverse effects
- How to store Clorhexlan
- Contents of the pack and other information
1. What Clorhexlan is and what it is used for
Clorhexlan 20 mg/ml is a solution for cutaneous use, the active substance of which is chlorhexidine digluconate.
It is used in adults and children as a skin antiseptic to prevent infections prior to invasive medical procedures such as injections, insertion of intravascular catheters, and minor and major surgery.
2. What you need to know before using Clorhexlan
Do not use Clorhexlan
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 nurse before using this medicine.
Clorhexlan is for external use on the skin only. Do not ingest.
Clorhexlan must not be used:
- Near sensitive areas (mucous membranes), as it may cause irritation. In case of contact with mucous membranes of the body's entry points, the affected area should be immediately washed with abundant water.
- In contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse the eyes with water. If eye irritation, redness or 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 accidentally came into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).
- On open wounds.
- Inside the ear (middle ear).
- In direct contact with neural tissue (e.g., brain and spinal cord).
Avoid prolonged contact with the skin. When applying occlusive dressings to areas previously treated with Clorhexlan, take special care to ensure there is no excess product before applying the dressing.
Do not use excessive amounts and avoid the solution accumulating in skin folds, under the patient, or soaking into sheets or other materials in direct contact with the patient.
Materials soaked with the solution, such as surgical drapes or gowns, must be removed before use. Do not allow the solution to pool.
Clorhexlan may, in rare cases, 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").
Children
Use with caution in neonates, especially in premature infants. Clorhexlan used as a skin antiseptic prior to invasive procedures may cause chemical burns on the skin of neonates.
Use with caution in neonates, particularly those born before 32 weeks of gestation and during the first two weeks of life.
Other medicines and Clorhexlan
The activity of chlorhexidine is reduced by alkaline pH, anionic detergents, and tannins:
- In general, due to possible interactions (antagonism, inactivation, etc.), simultaneous or sequential use of antiseptics should be avoided, except with other cationic compounds.
- Must not be used in combination with, or after application of, anionic soaps, iodine, heavy metal salts, or acids.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse before using this medicine.
Driving and use of machines
Clorhexlan does not affect the ability to drive or operate machinery.
3. How to use Clorhexlan
Your doctor or nurse will select the amount of solution required depending on the medical procedure, the area to be treated, and the surface area to be covered. If in doubt, ask your doctor or pharmacist.
Use undiluted. Clean and dry the skin before applying the medicine. Apply directly to the affected area or onto a gauze pad. Leave it on for the time indicated according to the medical procedure.
Clorhexlan is for topical use on the skin only.
If you use more Clorhexlan than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Stop treatment with this medicine if you experience any of the following symptoms: swelling of the face, lips, tongue or throat; red, itchy rash on the skin; difficulty breathing; feeling dizzy or faint; metallic taste; collapse. You may be experiencing an allergic reaction if any of these symptoms occur.
Stop using this medicine and consult your doctor or nurse if you develop eczema, blisters, swelling, or experience pain or itching at the site of skin where the product has been applied.
Other possible adverse effects are:
Very rare (less than 1 in 10,000 people): hypersensitivity skin reactions (including erythema, rash, itching and blisters at the application site), skin burning sensation, pain and inflammation have been reported. Discontinue use of this medicine and seek immediate medical attention if you experience any of the adverse reactions described. You may be having an allergic reaction.
Adverse effects with unknown frequency (cannot be estimated from available data): dermatitis, eczema, urticaria, skin irritation, blisters, chemical burns in neonates, hypersensitivity reactions and anaphylactic shock during anaesthesia. Corneal injury (damage to the surface of the eye) and permanent eye injury, including permanent visual impairment (following accidental eye exposure during surgical procedures on the head, face and neck) in patients under general anaesthesia (induced pain-free deep sleep).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Clorhexlan
No special storage conditions are required.
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.
Discard the container 3 months after first opening.
Medicines should not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Clorhexlan
- The active substance is chlorhexidine digluconate. Each ml contains 20 mg of chlorhexidine digluconate. Each ml corresponds to 5 actuations of 200 microliters, each containing 4 mg of chlorhexidine digluconate.
- The other component (excipient) is purified water.
Appearance of Clorhexlan and contents of the container
A clear, colourless or slightly yellowish solution supplied in high-density polyethylene bottles equipped with a spray pump.
Available in:
- Unit packs of 25 ml, 100 ml, and 125 ml.
- Clinical packs containing 20 bottles of 100 ml, 125 ml, and 250 ml.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
LAINCO, S.A.
Avda. Bizet, 8-12 - 08191 RUBÍ - Barcelona (Spain)
Date of the most recent revision of this leaflet: August 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/