Leaflet: information for the user

Quirocrom 20 mg/ml + 0.70 ml/ml topical solution

chlorhexidine digluconate / isopropyl alcohol

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions for 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 pharmacist.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

1. What isQuirocromand for what it is used

2. What you need to know before starting to use Quirocrom

3. How to use Quirocrom

4. Possible adverse effects

5. Storage of Quirocrom

6. Contents of the package and additional information

Quirocrom is a topical solution of chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml, which is used as a skin antiseptic before performing invasive medical procedures, such as injections, insertion of intravascular catheters, minor and major surgery in adults and children.

No useQuirocrom:

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

Warnings and precautions:

Quirocrom is only for external use on the skin. Do not ingest or inhale.

• The solution is flammable. Cases of fires in the operating room have been reported, resulting in severe burns to the patient.

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

To reduce the risk of fire:

Do not use electrocauterization procedures or other ignition sources until the skin is completely dry.

Remove any soaked materials, 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 the bedding or other materials in direct contact with the patient.

When applying occlusive dressings to areas previously exposed to Quirocrom, 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 an ignition source near an oxidizer put the patient at risk of suffering a surgical fire.

Quirocrom may, in rare cases, cause severe allergic reactions that can lead 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 Quirocrom and contact your doctor as soon as possible (see section 4: Possible side effects).

Avoid prolonged contact with the skin.

Do not use Quirocrom:

• Near the eyes or sensitive areas (mucous membranes), as it may cause irritation, pain, redness, vision problems, chemical burns, and eye injuries. In case of contact with the eyes or mucous membranes, immediately rinse the affected area with plenty of water.

Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord), and the middle ear.

Quirocrom 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 you experience eye irritation, redness, or pain, or vision changes, consult a doctor immediately.

Severe cases of persistent corneal injury (surface of the eye injury) have been reported, which may require a corneal transplant when similar products have accidentally entered 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).

Quirocrom 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 erythema, inflammation, itching, dry skin, and/or peeling, and pain. Stop administering Quirocrom at the first sign of any of these reactions.

Children

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

Other medications and Quirocrom

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

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

Avoid using it with different antiseptics to minimize the risk of possible interactions between them.

Do not use Quirocrom with anionic soaps, iodine, heavy metal salts, and acids.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

Quirocrom does not affect the ability to drive or operate machinery.

Your doctor or nurse will select the volume of solution based on the area to be treated and the area to be covered.Apply the product gently to the skin area that needs to be prepared. Do not dilute.

Ask your doctor or nurse if you are unsure.

If you use more Quirocrom 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 all people 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 possible adverse effects, for which the frequency is unknown, are:

-Allergic reactions, including anaphylactic shock.

-Eye irritation, pain, hyperemia, vision problems, chemical burns, and eye injuries in cases of accidental contact.

-Chemical burns in newborns.

-Skin allergic disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), eczema, rash, urticaria (hives), skin irritation, and blisters.

-Corneal injury (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) in patients.

Stop using Quirocrom and seek immediate medical attention if you experience any of the following reactions: facial swelling, lip, tongue, or throat swelling; red, itchy 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 packaging and its contents to open flames during use, storage, and disposal of the product.

Do not store at a temperature above 86°F (30°C).

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated. The medication should be discarded after 6 months of opening.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Quirocrom

The active principles are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.

The other components are purified water, Allura AC Red (E-129), and curcumin (E-100).

Appearance of the product and contents of the packaging

Transparent, reddish-colored solution presented in 100 ml and 250 ml plastic bottles. It is presented in:

• Clinical packaging of 30 bottles of 100 ml
• Clinical packaging of 15 bottles of 250 ml

Holder of the marketing authorization and responsible manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Last review date of this leaflet: July 2024

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