CRISTALMINA 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cristalmina 10 mg/ml cutaneous spray solution

chlorhexidine digluconate

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

Follow the instructions for administration 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 it is a side effect not listed in this leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 2 days.

Contents of the package leaflet

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

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

Cristalmina 10 mg/ml is a cutaneous antiseptic whose active ingredient is chlorhexidine digluconate.

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

2. What you need to know before you start 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 on the eyes, ears, or inside the mouth or 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 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 the 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 sites, nor for the disinfection of surgical equipment.
• Do not use excessive amounts and do not allow the solution to accumulate in skin folds or under the patient or drip onto sheets or other materials in direct contact with the patient.

Children

• Consult with your doctor before using in children under 30 months. The use in children from 2 months to under 30 months will be done exclusively under medical supervision for safety reasons.
• Chlorhexidine should not be used in children under 2 months of age for safety reasons.

Using Cristalmina with other medicines

• Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.
• The use of several antiseptics at the same time or successively should be avoided.
• It should not be used in combination or after the application of anionic soaps, acids, heavy metal salts, and iodine. In case the wound is cleaned with any of these products, 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.

There are no known risks associated with the use of Cristalmina 10 mg/ml during pregnancy or breastfeeding. It is not known whether chlorhexidine digluconate or any of its metabolites are excreted in breast milk. No effects are expected during pregnancy, or in newborns or breastfed babies, as the systemic exposure to chlorhexidine is insignificant. Cristalmina 10 mg/ml can be used during pregnancy or breastfeeding. Breastfeeding women should avoid using it on their breasts.

Driving and using machines

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

3. How to use Cristalmina 10 mg/ml

Always use this medicine exactly as indicated in this leaflet or as your doctor, pharmacist, or nurse has indicated. In case of doubt, ask your pharmacist.

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

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

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

You should consult your doctor if the wound worsens or does not improve within 2 days after 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, at a distance of approximately 10 cm from your skin. You can also spray the medicine onto a gauze and clean the damaged skin area. After application, let it act and dry.

Once the product is applied, the antimicrobial effect is achieved in 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 Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Cristalmina 10 mg/ml can cause side effects, although not everybody gets them.

Stop using Cristalmina 10 mg/ml and inform your doctor immediately if you have a severe allergic reaction. The frequency of this side effect is not known (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

Frequency not known:

• Chemical burns in neonates,
• allergic skin disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (redness of the skin), eczema, eruption, 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 it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website www.notificaRAM.es. By reporting side 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 packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at your pharmacy. If in doubt, consult your pharmacist on how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cristalmina 10 mg/ml

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

Transparent or slightly yellowish solution presented in:

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

Not all 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of last revision of this leaflet: June 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