Package Insert: Information for the Patient

Cristalmina 10 mg/mL Topical Solution

Digluconate of Chlorhexidine

Read the entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

1. What is Cristalmina 10 mg/mL and what it is used for

2. What you need to know before starting to use Cristalmina 10 mg/mL

3. How to use Cristalmina 10 mg/mL

4. Possible adverse effects

5. Storage of Cristalmina 10 mg/mL

6. Contents of the package and additional information

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

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

Do not use Cristalmina 10 mg/mL:

• 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 Cristalmina 10 mg/mL.
• 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 may require a corneal transplant when similar products have accidentally come into contact with 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 surfaces, with occlusive dressing (non-breathable), on injured skin and in mucous membranes.
• 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 tissues, but with domestic detergents based on sodium perborate.
• Do not use for the asepsis of puncture or injection sites, or for the disinfection of surgical equipment.
• Use with caution in newborns, especially in premature children. Cristalmina 10 mg/mL may cause chemical burns on the skin.
• Consult your doctor before using in children under 30 months.

Other medications and Cristalmina

• Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
• Avoid using 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, breastfeeding, and fertility

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

Driving and operating machines

No effects on the ability to drive and operate machines have been described after using Cristalmina 10 mg/mL.

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

Do not dilute. It is recommended to clean and dry the wound before applying Cristalmina 10 mg/mL. Apply to the affected area, or on a gauze, one or two times a day. Do not perform more than two daily applications of the product.

If you use more Cristalmina 10 mg/mL 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 everyone will experience them.

Stop using Cristalmina film 10 mg/mL 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 onset of sneezing or difficulty breathing.
• Fainting.
• 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 Use http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from light.

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 disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cristalmina 10 mg/mL

• The active ingredient is chlorhexidine digluconate. Each milliliter of topical solution contains 10 mg of chlorhexidine digluconate.
• The other component (excipient) is purified water.

Appearance of the product and content of the packaging

Transparent or slightly yellowish solution presented in a 25 mL glass vial with a screw cap and provided with a dropper with applicator.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

Laboratorios Salvat, S.A.

C/ Gall, 30-36

08950 Esplugues de Llobregat

Barcelona-Spain

or

PHARMALOOP, S.L.

C/Bolivia, 15-Polígono Industrial Azque

28806 Alcalá de Henares

Madrid-Spain

Last review date of this leaflet: July 2024

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