PRODUCT INFORMATION

Product Information:Information for the User

Clorxil yellow 20 mg/ml topical solution

chlorhexidine digluconate

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

• Keep this product information, 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 product information. See section 4.

• You should consult a doctor if it worsens or does not improve.

1.What is Clorxil yellow and what it is used for

2.What you need to knowbeforestarting touse Clorxil yellow

3.How to use Clorxil

4.Possible side effects

5Storage of Clorxil yellow

6.Contents of the package and additional information

Clorxil yellow contains chlorhexidine digluconate, used as a topical antiseptic.

It is indicatedas a skin antiseptic before performing invasive medical procedures, such as punctures, injections, catheter insertion, and preoperative field in surgeries, catheter maintenance, and surgical suturing in adults and children.

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

Consult your doctor or pharmacist before starting to use Clorxil yellow.

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

Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak into bedclothes or other materials in direct contact with the patient. Do not allow the solution to stagnate.

This medicine 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 medicine and contact your doctor as soon as possible (see section 4: “Possible side effects”).

Avoid prolonged contact with the skin.

This medicine 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 mucous membranes, wash the affected area immediately with plenty of water.

- Clorxil yellow should not come into contact with the eyes due to the risk of visual damage. If it enters 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).

- Directly on neural tissue (e.g., the brain and spinal cord).

- Clothing that has come into contact with Clorxil yellow should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the fabric, but with domestic detergents based on sodium perborate.

This medicine 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 area of administration. Stop administering this medicine at the first sign of any of these reactions.

Children

Use with caution in newborns, especially in premature babies. Clorxil yellow may cause chemical burns on the skin.

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

Other medicines and Clorxil yellow

Inform your doctor or pharmacist if you areusing, haveused recentlyor may have to use any other medicine.

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

The 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,breastfeedingand fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medicine.

The excretion of chlorhexidine digluconate in breast milk is unknown. As many medicines are excreted in breast milk, caution should be exercised when administering Clorxil yellow to lactating women.

Driving and operating machines

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

Apply the product gently to the area of skin that needs to be prepared. Apply as needed according to medical procedure. Do not dilute.

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

Consult your doctor or nurse if you are unsure.

If you use more Clorxil yellow 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, stating the medication and 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, eruption, 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 newborns.

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 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 about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

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

No special storage conditions are required

Medicines should not be disposed of through drains or in the trash. Ask your pharmacisthow to dispose ofthe packaging and themedicines that you no longerneed. In this way, you will help protect the environment.

Composition of Clorxil yellow

Per milliliter of solution:

The active ingredient 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 packaging

Transparent yellow solution that is presented in yellow HDPE/LDPE or HDPE plastic bottles with a white HDPE/LDPE stopper. It is presented in:

• Clinical packaging of 100 bottles of 20 ml.
• Clinical packaging of 50 bottles of 60 ml.
• Clinical packaging of 50 bottles of 100 ml.
• Clinical packaging of 50 bottles of 250 ml.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS BOHM, S.A.

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

28947 Fuenlabrada (Madrid)

Telephone: 91 642 18 18

Fax: 91 642 0572

Email: [email protected]

Revision date of this prospectus: April 2023

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/)