Introduction

Leaflet: information for the user

Alcomon reinforced 96º skin solution

Alcohol 96º/ cetilpyridinium chloride

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

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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
You should consult a doctor if it worsens or does not improve after 2 days.

1. What is Alcomon reforzado 96º and what is it used for

Skin antiseptic.

Consult a doctor if it worsens or does not improve after 2 days.

2. What you need to know before starting to use Alcomon reinforced 96º

Do not use Alcomon reforzado 96º

If you are allergic to the active principles of this medication (listed in section 6).

Do not apply to deep and extensive wounds, or mucous membranes.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Alcomon reforzado 96º.

Protect from heat. Highly flammable. Keep the container tightly closed.

Do not smoke during application.

Do not put in contact with mucous membranes.

Prolonged use may cause skin irritation and dryness.

May cause contact dermatitis.

Do not apply to wounds, as it irritates damaged tissue and may form a clot that protects resistant bacteria.

Avoid contact with eyes. If accidental contact with eyes occurs, wash abundantly with water and consult an ophthalmologist if necessary.

The solution is flammable.

The risk of fire is high when using a heat source (electrosurgical units, lasers, light sources, high-speed drills...) in combination with the use of a combustible source (cloths, towels...) and an oxidizer (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

Do not use electrocauterization procedures or other heat sources until the skin is completely dry.
Remove any soaked material, gauze, or gowns before starting the procedure.
Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or soak bedding or other materials in direct contact with the patient.
When applying occlusive dressings to areas previously exposed to Alcomon reforzado 96º, take special care to ensure there is no excess product before applying the dressing.
Reduce oxygen or any other oxidizer supply to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5) and the use of a heat source near an oxidizer put the patient at risk of suffering a surgical fire.

Pregnancy

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

3. How to use Alcomon reinforced 96º

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

Topical use. Only for external use. DO NOT INGEST.

Apply directly to the affected area, let it act for 2 minutes before any procedure.

It is recommended to wash your hands after each application.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

If you use more Alcomon reinforced 96º 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.

4. Possible Adverse Effects

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

Prolonged use may produce skin irritation and dryness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear 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.

5. Conservation of Alcomon reinforced 96º

Keep this medication out of the sight and reach of children.

Flammable. Avoid exposing the bottle and its contents to open flames during use, storage, and disposal of the product.

Do not store at high temperatures, it is easily flammable. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains, or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition per 100 ml of Alcomon reinforced 96º:

The active principle is ethanol 96% (alcohol 96º) and cetilpiridinio chloride.

Each ml of solution contains 0.999 ml of ethanol at 96% (alcohol 96º) and 1mg of cetilpiridinio chloride.

Each 100ml of solution contains 99.9ml of ethanol at 96% (alcohol 96º) and 0.1g of cetilpiridinio chloride.

It does not have other components (excipients).

Aspect of the product and contents of the packaging

Transparent cutaneous solution.

It is presented in transparent polyethylene containers of 250ml and 1000ml with a cap and stopper.

Additional information

In the absence of compatibility studies, this medication should not be mixed with others.

Holder of the marketing authorization and responsible for the manufacture

LABORATORIO REIG JOFRE, S.A.

Gran Capitán 10,

08970 Sant Joan Despí (Barcelona)

Last review date of this leaflet: July 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.