Cristalmina 10 mg/ml solution for cutaneous spray

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cristalmina 10 mg/ml solution for cutaneous spray

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 adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if you do not improve after 2 days.

Contents of the 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 adverse 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 topical antiseptic whose active ingredient is chlorhexidine digluconate.

Cristalmina 10 mg/ml is indicated as an antiseptic for minor superficial wounds such as mild burns, scratches, cuts, and abrasions in adults, adolescents, and children from 2 months of age onwards.

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.
• In the ears, especially if the eardrum is damaged.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Cristalmina 10 mg/ml.

• This medicine is for external use on the skin only. Do not ingest.
• Do not spray near the eyes, ears, inside the mouth, or on other mucous membranes. 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, rinse 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 could 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). This product must not be used on deep or extensive wounds without medical advice.
• Do not apply repeatedly, nor use over large skin areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
• Must not be used for disinfection of puncture or injection sites, or for sterilization of surgical instruments.
• Do not use excessive amounts and do not allow the solution to accumulate in skin folds or underneath the patient, or drip onto sheets or other materials in direct contact with the patient.

Children

• Consult a doctor before use in children under 30 months of age. Use in children from 2 months up to 30 months of age should be performed exclusively under medical supervision for safety reasons.
• Chlorhexidine must not be used in children under 2 months of age for safety reasons.

Use of Cristalmina with other medicines

• Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
• The simultaneous or sequential use of multiple antiseptics should be avoided.
• Must not be used in combination with, or after application of, anionic soaps, acids, heavy metal salts, or iodine. If the wound has been cleaned with any of these products, the skin should 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.

There are no known risks associated with the use of Cristalmina 10 mg/ml during pregnancy or breastfeeding. It is unknown whether chlorhexidine digluconate or any of its metabolites are excreted in breast milk. Systemic exposure to chlorhexidine is negligible; therefore, no effects on the fetus or breastfed infant are expected. Cristalmina 10 mg/ml may be used during pregnancy or breastfeeding. Breastfeeding women should avoid applying it to the breasts.

Driving and using machines

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

3. How to use Cristalmina 10 mg/ml

Always use this medicine exactly as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, ask your pharmacist.

Cristalmina 10 mg/ml should be used on your skin.

The recommended dose is a sufficient amount of product to cover the entire wound surface, applied 1 or 2 times daily, until the first signs of healing appear.

The duration of treatment depends on the type and course of the wound; experience indicates it is approximately 1 to 2 weeks.

You should consult your doctor if the wound worsens or does not improve within 2 days of starting treatment.

The spray is ready for use. Clean and dry the wound before applying the medicine. Spray Cristalmina 10 mg/ml directly onto the affected area from a distance of approximately 10 cm from your skin. Alternatively, you may spray the medicine onto a gauze pad and use it to clean the damaged skin area. After application, allow it to act and dry.

After application, antimicrobial effect is achieved within 1 minute.

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 at telephone number 91 562 04 20, stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Cristalmina 10 mg/ml can cause adverse effects, although not everyone will experience them.

Stop using Cristalmina 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

Frequency not known:

• 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 (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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at 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

Store below 30 ºC. 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. Return empty containers and any unused medicines to the pharmacy's SIGRE collection point . If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cristalmina 10 mg/ml

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

Additional information

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

Appearance of the product and contents of the container

Clear or slightly yellowish solution presented in:

• 25 mL glass bottle with a plastic spray pump and cap.
• 125 mL plastic bottle with a plastic spray pump and cap.
• Clinical packs containing 30 plastic bottles of 125 mL, 15 plastic bottles of 250 mL, or 10 plastic bottles of 500 mL, each with a plastic spray pump and cap.

Only some pack sizes may be marketed.

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 – Polig. Industrial Azque
28806 Alcalá de Henares, Madrid

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: June 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