CRISTALMINA 10 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet: information for the patient

Cristalmina 10 mg/mL cutaneous solution

Chlorhexidine digluconate

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

Follow the administration instructions of the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the leaflet

1. What is Cristalmina 10 mg/mL and what is it 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 side effects
5. Storage of Cristalmina 10 mg/mL
6. Package contents and additional information

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

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

It is indicated as an antiseptic for wounds and mild skin burns and as an antiseptic for the navel in newborns.

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

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 inside 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 that surround 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 damage. If it comes into contact with the eyes, wash 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 (injury to the surface of the eye) that could 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).

• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not apply repeatedly, nor use on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.
• Clothes that have come into contact with this medication should not be washed with bleach or other hypochlorites, as they would produce a brownish discoloration on the tissues, but with domestic detergents based on sodium perborate.
• Do not use for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.
• Use with caution in neonates, especially in premature babies. Cristalmina 10 mg/mL can cause chemical burns on the skin.
• Consult your doctor before using in children under 30 months.

Other medications and Cristalmina

• Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
• The use of several antiseptics at the same time or successively should be avoided, except with other cationic compounds.
• Do not use in combination or after applying anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be rinsed well after cleaning.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

No effects on driving ability and machine use have been described after using Cristalmina 10 mg/mL.

3. How to use Cristalmina 10 mg/mL

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 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.

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

• Sudden wheezing 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 spots on the skin.

These may be signs of an allergic reaction.

Other possible side effects, for which the frequency is unknown, are: - 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 (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this 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 contribute to providing more information on the safety of this medication.

5. Storage of Cristalmina 10 mg/mL

Do not store above 30°C.

Keep 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cristalmina 10 mg/mL

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

Appearance of the product and package contents

Transparent or slightly yellowish solution presented in a 25 mL glass bottle, with a screw cap and a dropper with an applicator.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Manufacturer

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

Date of the last revision of this 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