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Cristalmina 10 mg/ml solucion para pulverizacion cutanea

Cristalmina 10 mg/ml solucion para pulverizacion cutanea

About the medicine

Como usar Cristalmina 10 mg/ml solucion para pulverizacion cutanea

Introduction

PROSPECTO: INFORMATION FOR THE USER

Cristalmina 10 mg/ml skin spray solution

clorhexidina digluconate

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

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

  • Keep this prospect, as you may need to read it again.
  • If you need advice or more information, consult your pharmacist.
  • If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
  • You should consult your doctor if you worsen or do not improve after 2 days.

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

2. What you need to know before starting to use Cristalmina 10 mg/ml

3. How to use Cristalmina 10 mg/ml

4. Possible adverse effects

5. Storage of Cristalmina 10 mg/ml

6. Contents of the package and additional information

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

Cristalmina 10 mg/ml is an antiseptic for cutaneous use whose active ingredient is chlorhexidine digluconate.

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

2. What you need to know before starting to use 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 medication is exclusively for external use on the skin. 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, wash 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 should not come into contact with the eyes due to the risk of visual injury. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of eye irritation, redness, or pain, or visual disturbances, consult a doctor immediately.
  • Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which may require a corneal transplant when similar products have accidentally come into contact with the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).Do not use in case of deep and extensive wounds without consulting a doctor.
  • Do not apply repeatedly, or use on large areas, with occlusive dressing (non-breathable), on injured skin, and in mucous membranes.
  • Do not use for asepsis of puncture or injection sites, or for 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 bed sheets or other material in direct contact with the patient.

Children:

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

Use of Cristalmina with other medications:

  • Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
  • Avoid using multiple antiseptics at the same time or in succession.
  • Do not use in combination with or after application of anionic soaps, acids, heavy metal salts, and iodine. If 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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

No known risks have been identified with the use of Cristalmina 10 mg/ml during pregnancy or breastfeeding. The excretion of chlorhexidine digluconate or any of its metabolites in breast milk is unknown. No effects are anticipated during pregnancy, or in newborns or breastfeeding infants, as systemic exposure to chlorhexidine is insignificant. Cristalmina 10 mg/ml can be used during pregnancy or breastfeeding. Lactating women should avoid using it on their breasts.

Driving and operating machinery:

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

3. How to use Cristalmina 10 mg/ml

Use this medicine exactly as indicated 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 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, 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 an approximate distance of about 10 cm from your skin. You can also spray the medicine onto a gauze and clean the damaged skin area. After application, leave it to 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 Adverse Effects

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

Stop using Cristalmina 10 mg/ml and immediately inform your doctor if you have 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.
  • Loss of consciousness.
  • Swelling of the face.
  • Swelling of the mouth, tongue, or throat that may appear red and painful and/or cause difficulty swallowing.
  • Chest pain.
  • Red patches on the skin.

These may be signs of an allergic reaction.

Other possible adverse effects, for which the frequency is unknown

Unknown frequency:

- Chemical burns in newborns,

- allergic skin disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), eczema, rash, urticaria (hives), skin irritation, and blisters.

- Corneal injury (injury to the eye surface) and permanent eye injury, including permanent visual impairment (following accidental eye exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under general anesthesia (deep, painless sleep) in patients under 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5. Conservation of Cristalmina 10 mg/ml

Store below 30 °C. Store in the original packaging to protect it from light.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional 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.

Additional Information

  • Clothing that has been in contact with this medication, should not be washed with bleach or other hypochlorites as it would cause a brownish discoloration in the tissues, but with domestic detergents based on sodium perborate.

Appearance of the product and contents of the package

Transparent or slightly yellowish solution that is presented in:

  • 25 mL glass vial provided with a plastic spray pump and stopper.
  • 125 ml plastic vial provided with a plastic spray pump and stopper.
  • Clinical packaging of 30 plastic vials of 125 ml, 15 plastic vials of 250 ml or 10 plastic vials of 500 ml with plastic spray pump and stopper.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

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 medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) withthe following names:

Spain

Cristalmina 10 mg/ml solution for cutaneous application

Austria

Cristalmina 10 mg/ml Spray zur Anwendung auf der Haut, Lösung

Denmark

Cristalmina 10 g/ml Kutanspray, opløsning

Finland

Cristalmina 10 mg/ml Sumute iholle, liuos

Germany

Karedine 10 mg/ml Spray zur Anwendung auf der Haut, Lösung

Norway

Cristalmina

Portugal

Cristalmina 10 mg/ml Solução para pulverização cutânea

Sweden

Cristalmina 10 mg/ml Kutan spray, lösning

Last review date of this leaflet: June 2024

Updated and detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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