Label: Informationfor the User

Clorhexlan20 mg/ml skin spray solution

chlorhexidine digluconate

Read this label carefully before starting to use this medicine, as it contains important information for you

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or nurse.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

Clorhexlan 20 mg/ml is a skin solutionwhose active ingredient ischlorhexidine digluconate.

It is used in adults and children as a skin antiseptic, for the prevention of infections, before performing invasive medical procedures, such as injections, insertion of intravascular catheters, minor and major surgery.

Do not use Chlorhexlan

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

Warnings and precautions

Consult your doctor or nurse before starting to use this medication.

Chlorhexlan is only for external use on the skin.Do not ingest.

Chlorhexlan should not be used:

• Near sensitive areas (mucous membranes), as it may cause irritation. In case of contact with mucous membranes of the body's entryways, the affected area should be washed immediately with plenty of water.
• Chlorhexlan 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 eye irritation, redness, or pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which could require a corneal transplant when similar products have accidentally entered the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).

• On open wounds.
• On the inner part of the ear (middle ear).
• In direct contact with neural tissue (e.g., the brain and spinal cord).

Avoid prolonged contact with the skin. When applying occlusive dressing to previously exposed areas to Chlorhexlan, special care should be taken to ensure there is no excess product before placing the dressing.

Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak the patient's bedding or other materials in direct contact with the patient.

Soaked materials, such as surgical fields or gowns, should be removed before use. Do not allow the solution to stagnate.

Chlorhexlan 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").

Children

Use with caution in newborns, especially in premature babies. Chlorhexlan as a skin antiseptic before invasive procedures may cause chemical burns on the skin of newborns.

Use with caution in newborns, especially those born before 32 weeks of gestation and in the first two weeks of life.

Other medications and Chlorhexlan

The action of chlorhexidine is reduced by alkaline pH, anionic detergents, and tannins:

-In general, taking into account possible interference (antagonism, inactivation, etc.) should avoid simultaneous or successive use of antiseptics, except with other cationic compounds.

-Do not use in combination or after the application of anionic soaps, iodine, heavy metal salts, and acids.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

Chlorhexlan does not affect the ability to drive or operate machines.

Your doctor or nurse will select the required amount of solution based on the medical procedure, the area to be treated, and the area to be covered. If in doubt, ask your doctor or pharmacist.

Use without dilution. Clean and dry the skin before applying the medication. Apply directly to the affected area or on a gauze. Leave the medication to act for the time indicated based on the medical procedure.

Clorhexlan is only used on the skin.

If you use more Clorhexlan than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop treatment with this medication if you experience any of the following symptoms: swelling of the face, lips, tongue, or throat; red skin rash and itching; difficulty breathing; feeling of dizziness or fainting, strange metallic taste; collapse. You may be experiencing an allergic reaction if these symptoms appear.

Stop using this medication and consult your doctor or nurse if you experience eczema, blisters, inflammation, or experience pain or itching in the area of the skin where the product has been applied.

Other possible adverse effects are:

Very rare (less than 1 in 10,000 people):skin hypersensitivity reactions (including erythema, eruption, itching, and blisters at the administration site) have been reported,burning sensation in the skin, pain, and inflammation. Stop using this medication and seek immediate medical attention if you experience any of the adverse reactions described. You may be having an allergic reaction.

Adverse effects of unknown frequency(cannot be estimated from available data): dermatitis, eczema, urticaria, skin irritation, blisters, chemical burns in newborns, hypersensitivity reactions, and anaphylactic shock during anesthesia. Corneal lesion (surface eye injury) and permanent eye injury, including permanent visual deterioration (following accidental eye exposure during surgical interventions on the head, face, and neck) in patients under general anesthesia (deep, painless sleep induced).

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Medicinal Products for Human Use:https://www.notificaram.es.Reporting adverse effects can help provide more information on the safety of this medication.

This product does not require special conservation conditions.

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

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.

Dispose of the packaging after 3 months of the first opening.

Medicines should not be thrown down the drain or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Clorhexlan

Appearance of Clorhexlan and contents of the packaging

Clear, colorless or slightly yellowish solution presented in high-density polyethylene bottles, provided with a spray pump.

It is presented in:

-Single-unit containers of 25 ml, 100 ml, and 125 ml.

-Clinical containers of 20 bottles of 100 ml, 125 ml, and 250 ml.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12 - 08191 RUBÍ - Barcelona (Spain)

Last review date of this leaflet:August 2024

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