Cristalmina 10 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cristalmina 10 mg/mL cutaneous solution

Chlorhexidine digluconate

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Contents of this leaflet

1. What Cristalmina 10 mg/mL is and what it is used for
2. What you need to know before using Cristalmina 10 mg/mL
3. How to use Cristalmina 10 mg/mL
4. Possible side effects
5. How to store Cristalmina 10 mg/mL
6. Contents of the pack and other information

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

Cristalmina 10 mg/mL is a cutaneous medicinal product containing chlorhexidine digluconate as the active substance. Chlorhexidine is an antiseptic applied to the skin.

It is indicated as an antiseptic for skin wounds and minor burns, and as an antiseptic for the umbilicus in newborns.

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

Do not use Cristalmina 10 mg/mL:

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Cristalmina 10 mg/mL.
• This medicine is for external use only on the skin. Do not ingest.
• In case of accidental contact with eyes or ears, rinse 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 must not come into contact with the eyes due to the risk of visual damage. If contact occurs, wash immediately and thoroughly with abundant water. In case of eye irritation, redness or pain, or visual disturbances, consult a doctor immediately.

Severe 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 (induced painless deep sleep).

• Should not be used on deep or extensive wounds without consulting a doctor.
• Should not be applied repeatedly, nor used over large areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
• Clothing that has been in contact with this medicine should not be washed with bleach or other hypochlorites, as this may cause brownish staining of fabrics. Instead, wash with domestic detergents based on sodium perborate.
• Should not be used for disinfection of puncture or injection sites, or for disinfection of surgical instruments.
• Use with caution in neonates, especially in premature infants. Cristalmina 10 mg/mL may cause chemical burns on the skin.
• Consult with a doctor before use in children under 30 months of age.

Other medicines and Cristalmina

• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
• The simultaneous or sequential use of multiple antiseptics should be avoided, except with other cationic compounds.
• Should not be used in combination with, or after application of, anionic soaps (soaps), acids, heavy metal salts, or iodine. The skin should therefore be thoroughly rinsed after cleansing.

Pregnancy, breastfeeding and fertility

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

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported following the use of Cristalmina 10 mg/mL.

3. How to use Cristalmina 10 mg/mL

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 onto a gauze dressing, once or twice daily. Do not apply the product more than twice a day.

If you use more Cristalmina 10 mg/mL 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 can cause adverse effects, although not everyone experiences them.

Stop using Cristalmina film 10 mg/mL and inform your doctor immediately if you experience 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.
• Fainting.
• Swelling of the face.
• Swelling of the mouth, tongue, or throat, which 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 adverse effects, for which the frequency is unknown, are:

• chemical burns in neonates.

• Allergic skin disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation, and blisters.
• Corneal injury (damage to the surface of the eye) and permanent eye damage, 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).

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cristalmina 10 mg/mL

Do not store above 30°C.

Keep in the original packaging to protect from light.

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

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE Point . If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Cristalmina 10 mg/mL

• The active substance 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 contents of the container

Clear or slightly yellow solution supplied in a 25 mL glass bottle with screw cap, provided with a dropper 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 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