Leaflet:information for the user

Clorxil with alcohol orange 20 mg/ml + 0.49 ml/ml skin spray solution

chlorhexidine digluconate / ethanol

Read this leaflet carefully before starting to use this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• • If you need advice or more information, consult your pharmacist.
• If you experience any side effects,consult your doctor or nurse,eveniftheyare not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

1.What is Clorxil with alcohol orange and what is it used for

2.What you need to knowbeforestarting touse Clorxil with alcohol orange

3.How to use Clorxil with alcohol orange

4.Possible side effects

5Storage of Clorxil with alcohol orange

6.Contents of the package and additional information

Chlorhexidine with alcohol orange contains chlorhexidine digluconate and ethanol, used as a topical antiseptic.

It is indicated as a skin antiseptic prior to extractions, injections, catheter insertion and maintenance, surgical sutures, perilesional skin, punctures, and the surgical field in adults and children.

Do not use Chlorhexidine with alcohol orange

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Chlorhexidine with alcohol orange.

This medication is only for external use. Do not ingest, inhale.

The solution is flammable.

The risk of fire is high when using a source of ignition (electrosurgical units, lasers, fiber optic light sources, high-speed drills...) in combination with the use of a combustion source (cloths, towels...) and the use of an oxidizer (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

• Do not use sources of ignition until the skin is completely dry.
• Remove any soaked material, gauze, or gowns before starting the procedure.
• Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or soak bedding or other materials in direct contact with the patient. Do not allow the solution to pool.
• When applying occlusive dressings to areas previously exposed to Chlorhexidine with alcohol orange, take special care to ensure there is no excess product before applying the dressing.
• Reduce oxygen supply or any other oxidizer to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5) and the use of a source of ignition near an oxidizer put the patient at risk of suffering a surgical fire.

This medication 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").

Avoid prolonged contact with the skin.

This medication 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 eyes or mucous membranes of the body's entryways, the affected area should be washed immediately with plenty of water.
• Chlorhexidine with alcohol orange 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. If irritation, redness, or pain in the eyes, or visual disturbances occur, consult a doctor immediately.

Severe cases of persistent corneal injury (surface of the eye injury) that may require a corneal transplant have been reported when similar products have accidentally come into contact with 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).
• Clothing that has come into contact with Chlorhexidine with alcohol should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.

This medication should only be applied to the skin gently. If the solution is applied too vigorously to fragile or sensitive skin, or after repeated use, it may cause a local skin reaction with erythema, inflammation, itching, dry skin, and/or peeling, and localized pain in the administration area. If you notice any of these reactions, stop administering this medication.

Children

Use with caution in newborns, especially in premature babies. Chlorhexidine with alcohol orange may cause chemical burns on the skin.

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

Other medications and Chlorhexidine with alcohol orange

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

Notify your doctor or nurse if you have recently received a vaccine or injection for a skin test (epicutaneous tests for detecting allergies).

Simultaneous or successive use of other antiseptics should be avoided to minimize the risk of possible interactions between them.

The product is incompatible with anionic derivatives (soaps) and should be thoroughly rinsed off the skin after cleaning.

Pregnancy,breastfeeding, and fertility

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

The excretion of chlorhexidine digluconate or ethanol in breast milk is unknown. As many medications are excreted in breast milk, caution should be exercised when administering Chlorhexidine with alcohol to breastfeeding women.

Driving and operating machinery

Chlorhexidine with alcohol orange does not affect the ability to drive or operate machinery.

Apply the product gently to the area of skin that needs to be prepared. Spray as needed according to medical procedure. Each spray is equivalent to a volume of 105 microliters. Do not dilute.

Apply the product directly to the treatment area and allow it to dry before any procedure.

Ask your doctor or nurse if you are unsure.

If you use more Clorxil with alcohol orange 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 0420, indicating the medication and the amount ingested.

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

The 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 administration site. Other local symptoms may be: burning sensation on the skin, pain, and inflammation.

Other adverse effects with an unknown frequency (the 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 (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

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

-Dermatitis, eczema, urticaria, skin irritation, blisters

-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 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication is flammable. Avoid exposure of the bottle and its contents to open flames during use, storage, and disposal of the product.

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

Keep the bottle perfectly closed to protect it from light.

Do not usethis medicationafter the expiration date that appears onthe labelafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacisthow to disposeofthecontainers and of themedicines that you no longerneed. This way, you will help protect the environment.

Composition of Clorxil with orange alcohol

The active principles are: chlorhexidine digluconate and ethanol

The other components (excipients) are: glycerin, carmoisine, azorubine (E-122)

Natracol curcumin (polysorbate 80, propylene glycol and curcumin (E-100)) and purified water

Each milliliter of solution contains: 20 mg of chlorhexidine digluconate and 0.49 ml of ethanol.

Appearance of the product and contents of the packaging

Transparent reddish-colored solution that is presented in orange HDPE plastic bottles with white PP/PE spray valves containing 100 ml or 250 ml It is presented in:

• Clinical packaging of 50 bottles of 100 ml
• Clinical packaging of 50 bottles of 250 ml

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS BOHM, S.A.

C/ Molinaseca 23-25. Cobo Calleja Industrial Estate.

28947 Fuenlabrada (Madrid)

Phone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Revision date of this prospectus: May 2024

Other sources of information

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