Leaflet: information for the user

Cristalmina Plus 20 mg/ml + 0.70 ml/ml skin spray 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 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 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 is Cristalmina Plus and what it is used for

2. What you need to know before starting to use Cristalmina Plus

3. How to use Cristalmina Plus

4. Possible adverse effects

5. Storage of Cristalmina Plus

6. Contents of the pack and additional information

Cristalmina Plus 20 mg/ml + 0.70 ml/mlis 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 useCristalmina Plus:

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:

Cristalmina Plus 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 (electrosurgical 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 electrocautery procedures or other 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 the bedding or other material in direct contact with the patient.

When applying occlusive dressings to areas previously exposed to Cristalmina Plus, 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 in 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.

Cristalmina Plus 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 Cristalmina Plus and contact your doctor as soon as possible (see section 4: Possible side effects).

Avoid prolonged contact with the skin.

Cristalmina Plus should not be used:

• 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 of the body's entryways, 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.

Cristalmina Plus 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 damage (damage to the surface of the eye) 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 induced).

• 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).

Cristalmina Plus 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. If any of these reactions occur, stop administering Cristalmina Plus.

ChildrenUse with caution in newborns, especially in premature infants. Cristalmina Plus may cause chemical burns on the skin.

Other medications and Cristalmina Plus

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).

It is recommended to avoid using it with different antiseptics to minimize the risk of possible interactions between them.

Do not use Cristalmina Plus 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. Due to the fact that many medications are excreted in breast milk, caution should be exercised when administering Cristalmina Plus to breastfeeding women.

Driving and operating machinery

Cristalmina Plus 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 the medical procedure. Each spray is equivalent to a volume of 160 microliters. Do not dilute.

Ask your doctor or nurse if you are unsure.

If you use more Cristalmina Plus 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 may experience them.

The very rare adverse effects (less than 1 in 10,000 people) observed on the skin and subcutaneous tissue are:

Dermatitis, 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.

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-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 (injury to the eye surface) 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 anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep).

Stop using Cristalmina Plus and seek immediate medical attention if you experience any of the following reactions: swelling of the face, lips, tongue, or throat; 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 about 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 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.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Cristalmina Plus

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

The excipient is purified water.

Appearance of the product and contents of the packaging

Transparent solution presented in white plastic (PET) bottles of 125 ml and 500 ml with a spray valve. It is presented in:

• Clinical packaging of 30 bottles of 125 ml
• Clinical packaging of 10 bottles of 500 ml

Holder of the marketing authorization and responsible manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the last review of this leaflet: July 2024

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