Cristalmina 10 mg/ml solucion para pulverizacion cutanea

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

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.

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.

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.

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

6. Contents of the packaging and additional information