Alcomon Reforzado 96º cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alcomon reforzado 96º cutaneous solution

Alcohol 96º / 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 more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 2 days.

Leaflet contents

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

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

Skin antiseptic.

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

2. What you need to know before using Alcomon reforzado 96º

Do not use Alcomon reforzado 96º

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 96º.

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

Do not smoke during application.

Avoid 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 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 gowns before starting the procedure.
• Do not use excessive amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking bed linens or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Alcomon reforzado 96º, care must be taken to ensure there is no excess product before placing 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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

3. How to use Alcomon reforzado 96º

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Apply directly to the area to be treated, leave 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 96º 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 everyone will experience them.

Prolonged use may cause skin irritation and dryness.

Reporting of adverse effects

If you experience any type of 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 through 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 96º

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 30°C.

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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to 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. Package contents and additional information

Composition per 100 ml of Alcomon reinforced 96º:

The active substances are ethanol 96% (96º alcohol) and cetylpyridinium chloride.

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

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

It contains no other components (excipients).

Appearance of the product and contents of the container

Clear, transparent cutaneous solution.

Presented in transparent 250 ml and 1000 ml polyethylene containers, provided with cap and closure.

Additional information

In the absence of compatibility studies, this medicinal product 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 latest revision of this leaflet: July 2024

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/.