Cristalmina Plus 20 mg/ml + 0.70 ml/ml solution for cutaneous spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cristalmina Plus 20 mg/ml + 0.70 ml/ml cutaneous spray solution
chlorhexidine digluconate / isopropyl alcohol
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or as directed 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 any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not get better.
Contents of this leaflet
- What Cristalmina Plus is and what it is used for
- What you need to know before using Cristalmina Plus
- How to use Cristalmina Plus
- Possible adverse effects
- How to store Cristalmina Plus
- Contents of the pack and other information
1. What Cristalmina Plus is and what it is used for
Cristalmina Plus 20 mg/ml + 0.70 ml/ml is a topical solution containing 20 mg/ml chlorhexidine digluconate and 0.70 ml/ml isopropyl alcohol, used as a skin antiseptic prior to performing invasive medical procedures, such as injections, insertion of intravascular catheters, and minor or major surgery in adults and children.
2. What you need to know before using Cristalmina Plus
Do not use Cristalmina Plus:
If you are allergic (hypersensitive) to chlorhexidine digluconate, isopropyl alcohol, or any of the other components of this medicine (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 surgical fires have been reported, resulting in severe burns to the patient.
The risk of fire in the operating room is high when an ignition source (electrosurgical units, lasers, fiber-optic light sources, high-speed drills/burs) is used in combination with a combustible material (such as drapes, 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 surgical gowns before starting the procedure.
- Do not use excessive amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking into sheets or other materials in direct contact with the patient.
- When applying an occlusive dressing to areas previously exposed to Cristalmina Plus, ensure there is no excess product before applying the dressing.
- Reduce the supply of oxygen or any other oxidizing agent to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5), combined with the use of an ignition source near an oxidizing agent, place the patient at risk of surgical fire.
Cristalmina Plus may, in rare cases, cause severe allergic reactions that can lead to a drop in blood pressure and even loss of consciousness. Early signs of a severe allergic reaction may include skin rash or asthma. If you notice these symptoms, stop using Cristalmina Plus immediately and contact your doctor as soon as possible (see section 4: Possible side effects).
Avoid prolonged contact with the skin.
Cristalmina Plus must 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 body entry mucous membranes, immediately rinse the affected area thoroughly with water.
Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord), and the middle ear.
Cristalmina Plus must not come into contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse the eyes with water. In case of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately. Serious cases of persistent corneal injury (damage to the surface of the eye) have been reported, which may require corneal transplantation, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (deep, painless induced sleep).
- On open wounds.
- Inside the 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 on fragile or sensitive skin, or after repeated use, erythema, inflammation, itching, dry and/or scaly skin, and pain may occur. At the first sign of any of these reactions, discontinue use of Cristalmina Plus.
Children Use with caution in neonates, especially premature infants. Cristalmina Plus may cause chemical burns to the skin.
Other medicines and Cristalmina Plus
Inform your doctor or nurse if you are using, have recently used, or might need to use any other medicines.
Tell your doctor or nurse if you have recently received a vaccine or an injection for a skin test (epicutaneous tests to detect allergies).
Concomitant use with various antiseptics should be avoided to minimize the risk of potential interactions between them.
Do not use Cristalmina Plus together with anionic soaps, iodine, heavy metal salts, or 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 medicine.
It is unknown whether chlorhexidine digluconate or isopropyl alcohol are excreted in human breast milk. Because many medicines are excreted in breast milk, caution should be exercised when administering Cristalmina Plus to breastfeeding women.
Driving and using machines
Cristalmina Plus does not affect the ability to drive or operate machinery.
3. How to use Cristalmina Plus
Gently apply the product to the area of skin that needs to be prepared. Spray as many times as necessary, depending on the medical procedure. Each spray delivers a volume of 160 microliters. Do not dilute.
If you have any doubts, consult your doctor or nurse.
If you use more Cristalmina Plus than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
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 application site. Other local symptoms may include: skin burning sensation, pain, and inflammation.
Other possible adverse effects, for which the frequency is unknown, are:
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Allergic reactions including anaphylactic shock.
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Eye irritation, pain, hyperemia, vision problems, chemical burns and eye injuries in cases of accidental contact.
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Chemical burns in neonates.
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Allergic skin disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), eczema, rash, urticaria (hives), skin irritation, and blisters.
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Corneal lesion (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 (induced painless deep 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 faint or dizzy; unusual metallic taste in the mouth; collapse. You may be experiencing an allergic reaction.
Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cristalmina Plus
This medicine 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 medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cristalmina Plus
The active substances are clorhexidina digluconato 20 mg/ml and alcohol isopropílico 0.70 ml/ml.
The excipient is purified water.
Appearance of the product and contents of the container
Clear solution presented in white plastic (PET) bottles of 125 ml and 500 ml with spray pump. Available in:
- Clinical pack of 30 bottles of 125 ml
- Clinical pack 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 most recent review of this leaflet: July 2024
Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es