ALCOMON REFORZADO 96º SKIN SOLUTION

Introduction

Package Leaflet: Information for the User

Alcomon Reinforced 96º Cutaneous Solution

Alcohol 96º/ Cetylpyridinium Chloride

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

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

Contents of the Package Leaflet

1. What Alcomon Reinforced 96º is and what it is used for
2. What you need to know before starting to use Alcomon Reinforced 96º
3. How to use Alcomon Reinforced 96º
4. Possible side effects
5. Storage of Alcomon Reinforced 96º
6. Contents of the pack and further information

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

Skin antiseptic.

You should 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 Reinforced 96º

If you are allergic to the active ingredients 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 Reinforced 96º.

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

Do not smoke during application.

Do not bring into 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 crust that protects resistant bacteria.

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

The solution is flammable.

The risk of fire is high when using an ignition source (electrosurgical units, lasers, fiber optic light sources, high-speed drills...) in combination with a combustion source (such as cloths, towels...) and an oxidizing agent (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

• Do not use electrocauterization procedures or other ignition sources until the skin is completely dry.
• Remove any soaked material, gauzes, or gowns before starting the procedure.
• Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Alcomon Reinforced 96º, take special care to ensure there is no excess product before applying the dressing.
• Minimize the supply of oxygen or any other oxidizing agent to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizing agent put the patient at risk of surgical fire.

Pregnancy

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

The influence of this medication on the ability to drive and use machines is negligible or non-existent.

3. How to Use Alcomon Reinforced 96º

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.

For cutaneous use. For external use only. DO NOT INGEST.

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

It is recommended to wash your hands after each application.

If you have any further 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 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.

Prolonged use may cause skin irritation and dryness.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage 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 above 30°C.

It is highly flammable. Store in the original packaging to protect it from light.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition per 100 ml of Alcomon Reinforced 96º:

The active ingredient is ethanol 96% (alcohol 96º) and cetylpyridinium chloride.

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

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

It has no other components (excipients).

Appearance of the product and packaging contents

Transparent cutaneous solution.

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

Further information

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

Marketing Authorization Holder and Manufacturer

LABORATORIO REIG JOFRE, S.A.

Gran Capitán 10,

08970 Sant Joan Despí (Barcelona)

O

Pharmex Advanced Laboratories, SL

Ctra. A-431 Km. 19

Almodóvar del Río, 14720 - Córdoba

Date of the last revision of this package leaflet: July 2024

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/.