ALCOMON REFORZADO 70º SKIN SOLUTION

Introduction

Package Leaflet: Information for the User

Alcomon Reinforced 70º Cutaneous Solution

Alcohol 70º/Cetylpyridinium Chloride

Read the entire package leaflet carefully before starting to use this medicine, 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 70º is and what it is used for
2. What you need to know before starting to use Alcomon Reinforced 70º
3. How to use Alcomon Reinforced 70º
4. Possible side effects
5. Storage of Alcomon Reinforced 70º
6. Contents of the pack and further information

1. What Alcomon Reinforced 70º 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 70º

Do not use Alcomon Reinforced 70º

If you are allergic to the active ingredients of this medicine (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 70º.

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

Do not smoke during application.

Do not come 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 scab 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/burs...) 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 electrocautery 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 70º, take special care to ensure there is no excess product before applying the dressing.
• Reduce the oxygen supply or any other oxidizing agent to the minimum necessary. Those 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 suffering a 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 using machines

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

3. How to use Alcomon Reinforced 70º

Follow exactly the administration instructions of this medicine 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 on the use of this medicine, ask your doctor, pharmacist, or nurse.

If you use more Alcomon Reinforced 70º 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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Prolonged use may cause skin irritation and dryness.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es.

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

5. Storage of Alcomon Reinforced 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 30°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Alcomon Reinforced 70º

The active ingredients are ethanol 70% (alcohol 70º) and cetylpyridinium chloride.

Each ml of solution contains 0.999 ml of ethanol at 70% (alcohol 70º) and 1 mg of cetylpyridinium chloride.

Each 100 ml of solution contains 99.9 ml of ethanol at 70% (alcohol 70º) and 0.1 g of cetylpyridinium chloride.

It has no other ingredients (excipients).

Appearance of the product and contents of the pack

Transparent cutaneous solution.

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

Further information

In the absence of compatibility studies, this medicine 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.