CUVEFILM 10 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the Patient

CUVEFILM10 mg/ml cutaneous solution

Chlorhexidine digluconate

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as 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 package 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 CUVEFILM and what is it used for
2. What you need to know before using CUVEFILM
3. How to use CUVEFILM
4. Possible side effects
5. Storage of CUVEFILM
6. Contents of the packaging and additional information

1. What is CUVEFILM and what is it used for

It is a medication for cutaneous use that contains chlorhexidine digluconate as the active ingredient. Chlorhexidine is an antiseptic that is applied to the skin.

It is indicated as an antiseptic for wounds and minor burns of the skin 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 using CUVEFILM

Do not use CUVEFILM:

• If you are allergic to chlorhexidine digluconate or any of the other components of this medication (listed in section 6).
• Do not use in eyes or ears, or inside the mouth or on other mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use CUVEFILM.

• This medication is exclusively for external use on the skin. Do not ingest.
• Avoid contact with the brain, meninges (the membranes that surround the brain and spinal cord), and the middle ear.

• In case of accidental contact with eyes or ears, rinse immediately with plenty of water.
• 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.
• Clothes that have come into contact with this medication should not be washed with bleach or other hypochlorites, as a brownish discoloration would occur on the tissues, but with domestic detergents based on sodium perborate.
• It should not be used for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.
• CUVEFILM should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, rinse 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).

Children

Use with caution in neonates, especially in premature babies. CUVEFILM can cause chemical burns on the skin.

Consult with your doctor before using in children under 30 months.

Other medications and CUVEFILM

Use of CUVEFILM with other medications. Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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 medication.

Driving and using machines

No effects on the ability to drive and use machines have been described after using CUVEFILM.

3. How to use CUVEFILM

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is recommended to clean and dry the wound before applying CUVEFILM. Apply undiluted to the affected area, or to a gauze, one or two times a day. Do not perform more than two daily applications of the product.

If the symptoms worsen or do not improve after 5 days, consult your doctor.

If you use more CUVEFILM 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 medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Other possible side effects, for which the frequency is unknown, are:

• skin allergic disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), 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).

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of CUVEFILM

Keep this medication out of sight and reach of children.

Store in the original packaging to protect it from light.

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 thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of CUVEFILM

• The active ingredient is chlorhexidine digluconate, each ml contains 10 mg of chlorhexidine digluconate.
• The other components (excipients) are: purified water.

Appearance of the product and contents of the packaging

Transparent, colorless, and odorless liquid.

It is presented in 25 ml and 50 ml PET bottles with a dropper cap made of polyethylene.

Marketing authorization holder and manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last revision of this package leaflet: September2024

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