CRISTALMINA PLUS 20 mg/ml + 0.70 ml/ml CUTANEOUS SPRAY SOLUTION

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

Do not useCristalmina Plusif:

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

• The solution is flammable. Cases of fire 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 an ignition source (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with a combustion source (such as cloths, towels...) and an oxidizing agent (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

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

Remove any soaked materials, gauzes, or gowns before starting the intervention.

Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient.

When applying an occlusive dressing to areas previously exposed to Cristalmina Plus, be careful not to leave excess product before applying the dressing.

Reduce oxygen or any other oxidizing agent supply to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizing agent 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 damage. In case of contact with the eyes or mucous membranes, the affected area should be rinsed immediately with plenty of water.

Avoid contact with the brain, meninges (membranes surrounding the brain and spinal cord), and 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, rinse immediately and abundantly with water. In case of irritation, redness, or pain in the eyes, or visual disturbances, consult a doctor immediately. Severe cases of persistent corneal injury (lesion of the eye surface) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes during surgical interventions in patients under general anesthesia (deep sleep induced without pain).

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

Cristalmina Plus should only be applied gently to the skin. 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. Upon the first sign of any of these reactions, administration of Cristalmina Plus should be stopped.

ChildrenUse with caution in neonates, especially in premature babies. Cristalmina Plus may cause chemical burns to the skin.

Other medications and Cristalmina Plus

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

Inform your doctor or nurse if you have recently been administered a vaccine or an injection for a skin test (epicutaneous tests to detect allergies).

The use of different antiseptics should be avoided to minimize the risk of possible interference 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, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medication.

It is unknown whether chlorhexidine digluconate or isopropyl alcohol is excreted in breast milk. Since many medications are excreted in breast milk, caution should be exercised when administering Cristalmina Plus to breastfeeding women.

Driving and using machines

Cristalmina Plus does not alter the ability to drive or operate machines.

3. How to use Cristalmina Plus

Apply the product gently to the area of skin that needs to be prepared. Spray as many times as necessary based on the medical procedure. Each spray is equivalent to a volume of 160 microliters. Do not dilute.

In case of doubt, ask your doctor or nurse.

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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Very rare side effects (less than 1 in 10,000 people) observed in 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 side effects, for which the frequency is unknown, are:

- Allergic reactions, including anaphylactic shock.

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

- Chemical burns in neonates.

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

- Corneal injury (lesion on the eye surface) and permanent eye damage, including permanent vision loss (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

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 and 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cristalmina Plus

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

Do not store above 30°C.

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

Do not use this medication after the expiration date stated on the container after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the container and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Cristalmina Plus Composition

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

The excipient is purified water.

Appearance of the Product and Package Contents

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

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

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the last revision of this package leaflet: July 2024

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