Patient Information Leaflet

CUVEFILM 10 mg/ml topical solution

Chlorhexidine digluconate

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

Follow exactly the administration instructions contained in this leaflet or those given 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 5 days

1. What is CUVEFILM and what it is 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 pack and additional information

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

It is indicated as a wound antiseptic and for minor skin burns, and as umbilical cord antiseptic in newborns.

Consult a doctor if it worsens or does not improve after 5 days.

No 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 in the interior of the mouth or 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 surrounding the brain and spinal cord) and the middle ear.

• In case of accidental contact with eyes or ears, wash immediately with plenty of water.
• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not apply repeatedly, or use on large surfaces, with occlusive dressing (non-breathable), on injured skin and in mucous membranes.
• Clothing that has come into contact with this medication should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.
• Do not use for the asepsis of puncture or injection areas, or for the disinfection of surgical material.
• CUVEFILM 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 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).

Children

Use with caution in newborns, especially in premature children. CUVEFILM may 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 used recently, or may need to use any other medication.

It is advisable to avoid the use of several antiseptics at the same time or in succession, except with other cationic compounds.

Do not use in combination with or after the application of anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be thoroughly rinsed after cleaning.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

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

Clean and dry the wound before applying CUVEFILM. Apply undiluted to the affected area, or on a gauze, one or two times a day. Do not perform more than two applications per day of the product.

If symptoms worsenor do not improveafter 5 days, consult with 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Other possible adverse 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 eye surface) and permanent eye injury, including permanent visual deterioration (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

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

Keep this medication out of the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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 PET bottles of 25 ml and 50 ml and a polyethylene dropper cap.

Holder of the marketing authorization and responsible for manufacturing

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last review of this leaflet: September2024

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/