Cuvefilm 10 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
CUVEFILM 10 mg/ml cutaneous solution
Chlorhexidine digluconate
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or further information, consult your pharmacist.
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If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or does not improve after 5 days.
Contents of the leaflet
- What CUVEFILM is and what it is used for
- What you need to know before using CUVEFILM
- How to use CUVEFILM
- Possible side effects
- How to store CUVEFILM
- Contents of the pack and other information
1. What CUVEFILM is and what it is used for
It is a topical medication containing chlorhexidine digluconate as the active substance. Chlorhexidine is an antiseptic applied to the skin.
It is indicated as an antiseptic for wounds and minor skin burns, and as an antiseptic for the umbilical area in newborns.
You should consult a doctor if your condition 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 to any of the other ingredients of this medicine (listed in section 6).
- Do not use in the eyes, ears, inside the mouth, or on other mucous membranes.
Warnings and precautions
Consult your doctor or pharmacist before using CUVEFILM.
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This medicine is for external use on the skin only. Do not swallow.
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Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord), and the middle ear.
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In case of accidental contact with eyes or ears, rinse immediately with plenty of water.
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Do not use on deep or extensive wounds without consulting your doctor.
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Do not apply repeatedly, or use over large areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
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Clothing that has come into contact with this medicine should not be washed with bleach or other hypochlorites, as this may cause a brownish discoloration of fabrics. Instead, wash with domestic detergents based on sodium perborate.
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Must not be used for skin antisepsis at puncture or injection sites, or for disinfection of surgical instruments.
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CUVEFILM must not come into contact with the eyes due to the risk of visual injury. If contact occurs, rinse immediately and thoroughly with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.
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Serious cases of persistent corneal injury (damage to the surface of the eye) have been reported, which may even require corneal transplantation, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).
Children
Use with caution in neonates, especially in premature infants. CUVEFILM may cause chemical burns on the skin.
Consult your doctor before using in children under 30 months of age.
Other medicines and CUVEFILM
Using CUVEFILM with other medicines. Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
The simultaneous or sequential use of several antiseptics should be avoided, except with other cationic compounds.
Do not use in combination with, or after application of, anionic soaps (soaps), acids, heavy metal salts, or iodine. Therefore, the skin must be thoroughly rinsed after cleansing.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported after using CUVEFILM.
3. How to use CUVEFILM
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in 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 onto a gauze dressing, one or two times a day. Do not apply the product more than twice daily.
If 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Other possible adverse effects, for which the frequency of occurrence is unknown, are:
- allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation, and blisters.
- corneal lesion (damage to the surface of the eye) and permanent eye injury, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anaesthesia (induced painless deep sleep).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of CUVEFILM
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of CUVEFILM
- The active substance 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 pack
Colourless, odourless, transparent liquid.
Supplied in 25 ml and 50 ml PET bottles with a polyethylene dropper cap.
Marketing Authorization Holder and Manufacturer
PHARMEX ADVANCED LABORATORIES, S.L.
Ctra. A-431 Km.19
14720 Almodóvar del Río (Córdoba)
Spain
Date of the most recent revision of this leaflet: September 2024
Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/