PATIENT INFORMATION LEAFLET

Cristalmina film 10 mg/g gel

Chlorhexidine digluconate

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 pharmacist.

• 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 5 days.

Cristalmina film 10 mg/g gel is a topical medication whose active ingredient is chlorhexidine digluconate. Chlorhexidine digluconate is an antiseptic applied to the skin.

It is indicated as a wound and minor burn antiseptic on the skin and as umbilical cord antiseptic in newborns.

Consult a doctor if it worsens or does not improve after 5 days.

Do not use Cristalmina film 10 mg/g gel :

• If you are allergic to chlorhexidine digluconate or any of the other components of this medication (listed in section 6).
• Do not use in eyes or ears, or in the interior of the mouth or other mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

• This medication is exclusively for external use on the skin. Do not ingest.
• In case of accidental contact with eyes or ears, wash immediately with plenty of water.
• Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord) and the middle ear.
• - Cristalmina 10 mg/ml should not come into contact with the eyes due to the risk of visual injury. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of eye irritation, redness or pain, or visual disturbances, consult a doctor immediately.
• Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which could require a corneal transplant when similar products have accidentally entered the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).
• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not apply repeatedly, or use on large areas, with occlusive dressing (non-breathable), on damaged skin and in mucous membranes.
• Do not use for the asepsis of puncture or injection sites, or for the disinfection of surgical equipment.

Children

• Use with caution in newborns, especially in premature babies. This medication may cause chemical burns on the skin.
• Consult your doctor before using in children under 30 months.

Other medications and Cristalmina film 10 mg/g gel

• Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
• It is advisable to avoid the use of multiple antiseptics at the same time or in succession, except with other cationic compounds.
• Do not use in combination with or after the application of anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be thoroughly rinsed after cleaning.

Pregnancy and breastfeeding

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

The excretion of chlorhexidine or any of its metabolites in breast milk is unknown.

The possible risk of systemic effects should be taken into account.

Driving and operating machines

The influence of this medication on the ability to drive or operate machines is negligible or insignificant.

Cristalmina film 10 mg/g gel contains benzyl alcohol:

This medication contains 20.0 mg of benzyl alcohol per gram of Cristalmina film.

Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Clean and dry the wound before applying this medication. Apply to the affected area, or on a gauze, one or two times a day. Do not apply more than two applications per day of the product.

If you use more Cristalmina film 10 mg/g gel 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.

Information for the healthcare professional

In case of accidental ingestion, proceed with gastric lavage and protection of the digestive mucosa. Cases of hemolysis have been described after ingestion of chlorhexidine. In case of hemolysis, blood transfusion may be necessary.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop using Cristalmina film 10 mg/g gel and immediately inform your doctor if you have a severe allergic reaction. The frequency of this adverse effect is unknown (cannot be estimated from available data). If you notice any of the following, contact your doctor immediately:

• Sudden wheezing or difficulty breathing.
• Loss of consciousness.
• Swelling of the face.
• Swelling of the mouth, tongue, or throat that may appear red and painful and/or cause difficulty swallowing.
• Chest pain.
• Red patches on the skin.

These may be signs of an allergic reaction.

Other possible adverse effects,for which the frequency is unknown, are:

- Chemical burns in newborns.

- Allergic skin 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).

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 Medicinal Products for Human Usehttp://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store below 25 °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 “Expiration Date”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cristalmina film 10 mg/g gel

• The active ingredient is chlorhexidine digluconate. Each gram of gel contains 10 mg of chlorhexidine digluconate.
• The other components (excipients) are alantoin, benzyl alcohol, hydroxypropylmethylcellulose, and purified water.

Additional information

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

Appearance of the product and contents of the packaging

Transparent, colorless, or slightly yellowish gel presented in aluminum tubes of 30 and 100 g.

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 for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es