Ceroxteril
Italy
Table of Contents
Package leaflet: Information for the patient
CEROXTERIL 0.1%+0.1% “cutaneous solution”
Chlorhexidine digluconate and Benzalkonium chloride
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms.
Contents of this leaflet
- What CEROXTERIL is and what it is used for
- What you need to know before using CEROXTERIL
- How to use CEROXTERIL
- Possible side effects
- How to store CEROXTERIL
- Contents of the pack and other information
1. What CEROXTERIL is and what it is used for
CEROXTERIL is used for disinfecting and cleaning the skin in the presence of minor superficial wounds, mild pressure ulcers (skin lesions affecting body parts subjected to prolonged pressure), and mild burns (first-degree burns).
The product may be used for surgical site preparation.
2. What you need to know before using CEROXTERIL
Do not use CEROXTERIL
If you are allergic to chlorhexidine digluconate, benzalkonium chloride, or any of the other ingredients
of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using CEROXTERIL.
CEROXTERIL should be applied only to external body surfaces or to surgical field surfaces.
This product must not be used for prolonged treatments. If no improvement occurs within a short time, consult your doctor.
CEROXTERIL, especially when used over long periods, may cause sensitization. If this occurs, discontinue use of the product and consult a doctor promptly.
The product may be irritating and cause skin reactions.
This product must not be applied to the surface of the eye, into the ear canal, or allowed to come into contact with the meninges or brain.
Do not ingest or inhale this product, as it may lead to serious, even fatal, consequences.
After applying the product, do not expose yourself to ultraviolet rays from sunlight or sunlamps.
In case of accidental ingestion, consult a doctor immediately.
Chlorhexidine may cause hypersensitivity, including anaphylactic shock and allergic reactions. If you experience any of these reactions, discontinue use of the product and consult a doctor promptly.
Children and adolescents
Consult your doctor or pharmacist before using CEROXTERIL on children or adolescents.
CEROXTERIL may cause chemical burns in newborns, particularly in premature infants.
Other medicines and CEROXTERIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not apply other antiseptics or detergents to the same area while using this product.
Benzalkonium chloride is not compatible with hydrogen peroxide; both benzalkonium chloride and chlorhexidine digluconate are incompatible with soaps and the following chemical substances: iodides and anionic materials.
CEROXTERIL with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
CEROXTERIL does not affect the ability to drive vehicles or operate machinery.
CEROXTERIL contains 50 mg of alcohol (ethanol) per ml of solution: it may cause a burning sensation on damaged skin.
In newborns (premature and full-term), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).
CEROXTERIL contains lemon essence, which in turn contains 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamal, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, lilial, cinnamal, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, oak moss, musk, farnesol, geraniol, cinnamic aldehyde, hydroxycitronellal, hydroxymethyl pentyl cyclohexene carboxaldehyde, isoeugenol, d-Limonene, linalool, methyl heptyn carbonate, which may cause allergic reactions.
3. How to use CEROXTERIL
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For surgical site preparation: rub the affected area with a sterile cotton or gauze swab soaked in the solution.
For cleaning and disinfection: apply CEROXTERIL to the affected area using cotton or gauze soaked in the solution, 2–3 times daily.
Do not exceed these doses.
If you use more CEROXTERIL than you should
Under the recommended conditions of use described above, no adverse effects due to overdose have been reported.
If you accidentally ingest a large amount of the product, inform your doctor immediately or go to the nearest hospital, as ingestion or inhalation of disinfectants may lead to serious, even life-threatening, health consequences. Nausea and vomiting may occur.
If you forget to use CEROXTERIL
Do not use a double dose to make up for the missed application.
If you stop using CEROXTERIL
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this product can cause side effects, although not everybody gets them.
Burning or skin irritation (intolerance) may occur. These effects are usually transient and generally do not require changes in treatment.
Frequency not known (frequency cannot be estimated from the available data): burns (chemical burns) in newborns.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store CEROXTERIL
Keep this medicine out of the sight and reach of children.
Store the product in a tightly closed container, protected from light and heat.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What CEROXTERIL contains
100 g of CEROXTERIL solution contain the following active substances: chlorhexidine digluconate 0.10 g and
benzalkonium chloride 0.10 g.
The other components are: ethanol, lemon flavour, purified water.
Description of the appearance of CEROXTERIL
200 ml bottle.
Marketing Authorisation Holder and Manufacturer
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900 Lodi
Manufacturer:
LABORATORIO CHIMICO FARMACEUTICO A. SELLA S.r.l.
Via Vicenza, 67
36015 – Schio (VI)
MINIMUM INFORMATION TO BE INDICATED ON THE PRIMARY PACKAGING TOGETHER WITH THE
PATIENT LEAFLET
VIAL
1. CONTENTS
200 ml bottle
2. EXPIRY DATE
Exp.
3. BATCH NUMBER
Batch
4. GENERAL SUPPLY CONDITION
Medicine for self-medication
5. MARKETING AUTHORISATION NUMBER
AIC No. 032318026