Menalcol Reforzado 70º cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Menalcol Reforzado 70º Cutaneous Solution

Alcohol 70º / chlorhexidine digluconate

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 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 you worsen or do not improve after 2 days.

Leaflet contents

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

1. What Menalcol reforzado 70º is and what it is used for

Skin antiseptic.

You should consult a doctor if symptoms worsen or do not improve after 2 days.

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

Do not use Menalcol 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 Menalcol 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.

Menalcol reforzado 70º cutaneous solution must not come into contact with the eyes due to the risk of visual injury. If contact occurs, rinse immediately and thoroughly with water. In case of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately.

Serious cases of persistent corneal injury (damage to the surface of the eye) have been reported, which could eventually require a corneal transplant, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).

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, gauzes, or drapes before starting the procedure.
• Do not use excessive amounts and avoid accumulation 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 Menalcol reforzado 70º, special care should be taken to 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.

Children

Use with caution in neonates, especially those born before week 32 of gestation and during the first 2 weeks of life. Menalcol reforzado 70º may cause chemical burns to the skin.

Do not use large amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking sheets or other wet materials in direct contact with the patient.

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 use of machines

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

3. How to use Menalcol reforzado 70º

Follow exactly the administration instructions for 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 leave 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 Menalcol 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 produce adverse effects, although not everyone experiences them.

Prolonged use may cause skin irritation and dryness.

Other possible adverse effects, for which the frequency is unknown, are:

• corneal lesion (damage to the surface of the eye) and permanent eye injury, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (induced painless deep sleep).

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 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 Menalcol Reforzado 70

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

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

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

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Menalcol Reforzado 70º:

The active substances are ethanol 70% (70º alcohol) and chlorhexidine digluconate.

Each ml of solution contains 0.995 ml of 70% ethanol (70º alcohol) and 0.005 ml of chlorhexidine digluconate.

Each 100 ml of solution contains 99.5 ml of 70% ethanol (70º alcohol) and 0.5 ml of chlorhexidine digluconate.

It contains no other components (excipients).

Appearance of the product and contents of the container

Clear, transparent cutaneous solution.

Supplied in a transparent 250 ml polyethylene bottle with a cap and tamper-evident seal.

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)

OR

Pharmex Advanced Laboratories, SL

Ctra. A-431 Km. 19

Almodóvar del Río, 14720 - Córdoba

Date of the most recent review of this leaflet: January 2019

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