Leaflet: information for the user

Menalcol reinforced 70º skin solution

Alcohol 70º/ chlorhexidine digluconate

Read this leaflet carefully before starting to use this medicine, as 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 not listed in this leaflet. See section 4.

-You should consult a doctor if it worsens or does not improve after 2 days.

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

2. What you need to know before starting to use Menalcol reinforced 70º

3. How to use Menalcol reinforced 70º

4. Possible side effects

5. Storage of Menalcol reinforced 70º

6. Contents of the pack and additional information

Skin antiseptic.

Consult a doctor if it worsens or does not improve after 2 days.

Do not use Menalcol reforzado 70º

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 Menalcol reforzado 70º.

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

Do not smoke during application.

Do not put in 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 clot that protects resistant bacteria.

Menalcol reforzado 70º skin solution should not come into contact with the eyes due to the risk of visual injury. If it comes into contact with the eyes, wash immediately and abundantly with water. If irritation, redness, or pain in the eyes, or visual disturbances occur, consult a doctor immediately.

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

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 the use of a combustion source (cloths, towels...) and the use of an oxidizer (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, gauze, or gowns before starting the procedure.

•Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak bedding or other materials in direct contact with the patient.

•When applying occlusive dressings to areas previously exposed to Menalcol reforzado 70º, take special care to ensure there is no excess product before applying the dressing.

•Reduce oxygen supply or any other oxidizer to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizer put the patient at risk of suffering a surgical fire.

Children

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

Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak bedding or other materials in direct contact with the patient.

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

It is recommended to wash your hands after each application.

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

If you use more Menalcol reinforced 70º than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects,

although not all people may experience them.

Prolonged use may cause skin irritation and dryness.

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

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.

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

Keep this medication out of the sight and reach of children.

Flammable. Avoid exposure of the bottle and its contents to open flames during use, storage, and disposal of the product.

Do not store at high temperatures, as it is easily flammable. Store in the original container

to protect it from light.

Do not use this medication after the expiration date that appears on the container. The

expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Menalcol reinforced 70º:

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

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

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

It does not contain other components (excipients).

Appearance of the product and contents of the packaging

Clear transparent skin solution.

It is presented in a 250 milliliter transparent polyethylene bottle with a cap and stopper.

Additional information

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

Holder of the marketing authorization and responsible for themanufacturing

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Date of the last review of this leaflet: July 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.