MENALCOL 0.5 ml/99.5 ml Topical Solution

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

Do not use Menalcol Reinforced 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 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 can irritate damaged tissue and form a scab that protects resistant bacteria.

Menalcol Reinforced 70º cutaneous solution should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of irritation, redness, or eye pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes during surgical interventions, in patients under general anesthesia (deep sleep induced without pain).

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...) 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, gauze, or gowns before starting the intervention.
• 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 Menalcol Reinforced 70º, take special care to ensure there is no excess product before applying the dressing.
• Reduce 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.

Children

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

Do not use high amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other moist materials in direct contact with the patient.

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 medication.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to Use Menalcol Reinforced 70º

Follow the administration instructions of this medication exactly as 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 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Prolonged use may cause skin irritation and dryness.

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

• Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.

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

5. Storage of Menalcol Reinforced 70º

Keep this medication out of 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 at high temperatures, as it is highly flammable. Store in the original package to protect it from light.

Do not use this medication after the expiration date shown on the package. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Menalcol Reinforced 70º:

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

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

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

It has no other components (excipients).

Appearance of the Product and Package Contents

Clear, transparent cutaneous solution.

It comes in a 250 ml transparent polyethylene bottle with a cap and seal.

Additional Information

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

Marketing Authorization Holder and Manufacturer

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Date of the Last Revision of this Package Leaflet: July 2024

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