Cristalmina Film 10 mg/g gel

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cristalmina film 10 mg/g gel

Chlorhexidine digluconate

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

Follow exactly the instructions for use provided in this leaflet or those given 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 the leaflet

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

1. What Cristalmina film 10 mg/g gel is and what it is used for

Cristalmina film 10 mg/g gel is a cutaneous medicinal product whose active substance is chlorhexidine digluconate. Chlorhexidine digluconate is an antiseptic applied to the skin.

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

You should consult a doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before using Cristalmina film 10 mg/g gel

Do not use Cristalmina film 10 mg/g gel:

• 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

Talk to your doctor or pharmacist before using this medicine.

• This medicine is for external use on the skin only. Do not swallow.
• 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 enter the eyes due to the risk of visual damage. If contact occurs, wash immediately and thoroughly with water. If eye irritation, redness, pain, or visual disturbances occur, 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 (induced painless deep sleep).
• Do not use in case of deep or extensive wounds without consulting your doctor.
• Do not apply repeatedly, or use over large skin areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
• Must not be used for antisepsis of puncture or injection sites, or for disinfection of surgical instruments.

Children

• Use with caution in neonates, especially in premature infants. This medicine may cause chemical burns on the skin.
• Consult your doctor before using in children under 30 months of age.

Other medicines and Cristalmina film 10 mg/g gel

• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
• The simultaneous or consecutive use of several antiseptics should be avoided, except with other cationic compounds.
• Must 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 cleaning.

Pregnancy and breastfeeding

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.

It is unknown whether chlorhexidine or any of its metabolites are excreted in human breast milk.

The potential risk of systemic effects should be considered.

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is none or negligible.

Cristalmina film 10 mg/g gel contains benzyl alcohol:

This medicine 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.

3. How to use Cristalmina film 10 mg/g gel

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

It is recommended to clean and dry the wound before applying this medicine. Apply to the affected area, or onto a gauze dressing, one or two times a day. Do not apply the product more than twice daily.

If you use more Cristalmina film 10 mg/g gel than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

Information for healthcare professionals

In case of accidental ingestion, perform gastric lavage and provide protection for the digestive mucosa. Cases of hemolysis following ingestion of chlorhexidine have been reported. In the event of hemolysis, blood transfusion may be necessary.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop using Cristalmina film 10 mg/g gel 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 frequency is unknown, include:

• Chemical burns in neonates.
• Allergic skin disorders such as dermatitis (inflammation of the skin), 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 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).

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 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 film 10 mg/g gel

Store below 25 °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 "Expiry". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 pack and other information

Composition of Cristalmina film 10 mg/g gel

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

Additional information

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

Appearance of the product and contents of the container

Colorless or slightly yellowish transparent gel, supplied in aluminum tubes of 30 g and 100 g.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the most recent revision 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