Alcomon Reforzado 70º cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alcomon reinforced 70º cutaneous solution

Alcohol 70º/cetylpyridinium chloride

Read the entire 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 days.

Contents of the leaflet

1. What Alcomon reinforced 70º is and what it is used for
2. What you need to know before using Alcomon reinforced 70º
3. How to use Alcomon reinforced 70º
4. Possible adverse effects
5. How to store Alcomon reinforced 70º
6. Contents of the pack and other information

1. What Alcomon Fortified 70º is and what it is used for

Skin antiseptic.

You should consult a doctor if your condition worsens or does not improve within 2 days.

2. What you need to know before using Alcomon reforzado 70º

Do not use Alcomon reforzado 70º

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

Do not apply on deep or extensive wounds, or on mucous membranes.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Alcomon reforzado 70º.

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

Do not smoke during application.

Do not allow contact with mucous membranes.

Prolonged use may cause skin irritation and dryness.

May cause contact dermatitis.

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

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

The solution is flammable.

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

To reduce the risk of fire:

• Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
• Remove any soaked materials, gauze, or drapes before starting the procedure.
• Do not use excessive amounts and avoid pooling of 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 reforzado 70º, ensure there is no excess product before applying the dressing.
• Reduce the supply of oxygen or any other oxidizing agent to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5), combined with the use of an ignition source near an oxidizing agent, place the patient at risk of surgical fire.

Pregnancy

If you are pregnant or 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

The effect of this medicine on the ability to drive and operate machinery is negligible or none.

3. How to use Alcomon reforzado 70º

Follow exactly the instructions for use of this medicine as indicated by your doctor or pharmacist. If in 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, and allow to act for 2 minutes before any procedure.

It is recommended to wash hands after each application.

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

If you use more Alcomon reforzado 70º than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Prolonged use may cause skin irritation and dryness.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alcomon Reforzado 70º

Keep this medicine 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 30ºC.

Highly flammable. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alcomon reforzado 70º

• The active substances are ethanol 96% (96º alcohol) and cetylpyridinium chloride.
• The other excipients are: purified water.

Each ml of solution contains 0.7292 ml of 96% ethanol (96º alcohol) and 1 mg of cetylpyridinium chloride.

Each 100 ml of solution contains 72.92 ml of 96% ethanol (96º alcohol) and 0.1 g of cetylpyridinium chloride.

Appearance of the product and contents of the container

Clear, transparent cutaneous solution.

It is presented in transparent 500 ml and 1000 ml polyethylene containers provided with a cap and closure.

Additional information

In the absence of compatibility studies, this medicine must 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 most recent revision of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.