CRISTALMINA FILM 10 mg/g GEL

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cristalmina film 10 mg/g gel

Chlorhexidine digluconate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, 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 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 package leaflet

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

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

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

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

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

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

Do not use Cristalmina film 10 mg/g gel:

• If you are allergic to chlorhexidine digluconate or any of the other components of this medicine (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 this medicine.

• This medicine is for external use on the skin only. 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 may 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).
• It should not be used in case of deep and extensive wounds without consulting a doctor.
• It should not be applied repeatedly, nor used on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.
• It should not be used for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.

Children

• Use with caution in neonates, especially in premature babies. This medicine can cause chemical burns to the skin.
• Consult with your doctor before using in children under 30 months.

Other medicines and Cristalmina film 10 mg/g gel

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

Pregnancy and breastfeeding

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

It is not known whether chlorhexidine or any of its metabolites are excreted in breast milk.

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

Driving and using machines

The influence of this medicine on the ability to drive or use machines is nil or insignificant.

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 of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 to a dressing, one or two times a day. Do not perform more than two daily applications 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 after ingestion of chlorhexidine have been described. In case of hemolysis, blood transfusion may be necessary.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Cristalmina film 10 mg/g gel and inform your doctor immediately if you have a severe allergic reaction. The frequency of this side effect is not known (it 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 be 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 not known, are:

• 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 (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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cristalmina film 10 mg/g gel

Keep below 25 ºC.

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

Do not use this medicine after the expiry date that appears on the packaging after "Expiry date". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

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 allantoin, benzyl alcohol, hydroxypropyl methylcellulose, and purified water.

Further information

• Clothes that have come into contact with this medicine should not be washed with bleach or other hypochlorites, as they may cause a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.

Appearance of the product and packaging contents

Colorless or slightly yellowish transparent gel presented in aluminum tubes of 30 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 last revision of this leaflet: July 2024

Updated and detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es