MENALMINA 10 MG/ML CUTANEOUS SPRAY SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Menalmina 10 mg/ml cutaneous spray solution

clorhexidina, digluconato

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You must consult your doctor if symptoms worsen or if you do not improve after 5 days.

Contents of the leaflet:

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

1. What Menalmina is and what it is used for

Menalmina 10 mg/ml is a topical medication whose active substance is chlorhexidine digluconate. Chlorhexidine is a cutaneous antiseptic applied to the skin.

It is indicated for minor superficial wounds such as mild burns, scratches, cuts, and abrasions in adults, adolescents, children, and babies from 2 months of age and older.

2. What you need to know before using Menalmina

Do not use Menalmina

• If you are allergic to chlorhexidine digluconate.
• In the eyes, ears, inside the mouth, or on other mucous membranes. It must be used exclusively on the skin.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Menalmina 10 mg/ml cutaneous spray solution.

• This medicine is for external use only on the skin. Do not ingest.
• Avoid contact with ears, inside the mouth, or other mucous membranes. In case of accidental contact, rinse immediately with abundant water.
• Avoid contact with the eyes due to the risk of visual injury. If contact occurs, rinse immediately and thoroughly with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.
• Serious cases of persistent corneal injury (damage to the surface of the eye) have been reported, which may require corneal transplantation, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).
• Do not use in cases of deep or extensive wounds without consulting a doctor.
• Do not apply repeatedly, nor use on large skin areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
• Must not be used for disinfection of puncture or injection sites, nor for disinfection of surgical instruments.
• Menalmina may cause chemical burns on the skin. Do not use large amounts and avoid solution pooling in skin folds, under the patient, or soaking bed linens or other wet materials in direct contact with the patient.

Children

Consult a doctor before use in children under 30 months of age. Use in children from 2 months up to under 30 months of age should be carried out exclusively under medical supervision for safety reasons.

Chlorhexidine must not be used in children under 2 months of age for safety reasons.

Use of other medicines

Inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Simultaneous or sequential use with other antiseptics should be avoided, except with other cationic compounds (e.g., quaternary ammonium salts).

Must not be used in combination, or after application of soaps or detergents, iodine, heavy metal salts (e.g., mercury and lead salts).

Simultaneous use of Menalmina with organic products (serum, etc.) or phospholipids should be avoided, as they may partially reduce its antiseptic activity.

Pregnancy, breastfeeding, and fertility

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.

There are no known risks associated with the use of Menalmina during pregnancy or breastfeeding. It is unknown whether chlorhexidine digluconate or any of its metabolites are excreted in breast milk. No effects are expected during pregnancy, or in newborns or breastfed infants, as systemic exposure to chlorhexidine is negligible. It may be used during pregnancy or breastfeeding. Breastfeeding women should avoid using it on their breasts.

Driving and use of machines

The influence of this medicine on the ability to drive and use machines is none or negligible.

3. How to use Menalmina

Use this medicine exactly as indicated in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, ask your pharmacist.

This medicine is for topical use on the skin.

The recommended dose is the amount sufficient to cover the entire wound surface, applied 1 or 2 times daily, until the first signs of healing appear. No more than 2 applications per day are recommended.

The duration of treatment depends on the type and progression of the wound; based on experience, it is approximately 1 to 2 weeks.

You should consult your doctor if the wound worsens or does not improve within 2 days of starting treatment.

The spray is ready to use. Clean and dry the wound before applying the medicine. Spray directly onto the affected area from a distance of approximately 10 cm from the skin. Alternatively, the medicine can be sprayed onto a gauze pad, which can then be used to clean the damaged skin area. After application, allow it to act and dry.

Use in children

Consult a doctor before using in children under 30 months of age. Use in children from 2 months up to but less than 30 months of age should be carried out exclusively under medical supervision for safety reasons.

Chlorhexidine should not be used in children under 2 months of age for safety reasons, due to the potential severity of chemical burns associated with the use of chlorhexidine skin solutions as a skin disinfectant in premature infants.

If you use more Menalmina than you should

No cases of overdose are known due to its external use on the skin. If any overuse occurs, discontinue treatment and consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact 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, Menalmina may cause adverse effects, although not everyone experiences them.

Stop using this medicine and inform your doctor immediately if you experience a severe allergic reaction. The frequency of this adverse effect is unknown (cannot be estimated from available data). If you notice any of the following, contact your doctor immediately:

• Sudden wheezing or difficulty breathing.
• Fainting.
• Swelling of the face.
• Swelling of the mouth, tongue, or throat, which may appear red and painful and/or cause difficulty swallowing.
• Chest pain.
• Red spots on the skin.

These may be signs of an allergic reaction.

Other possible adverse effects, for which frequency is unknown

Frequency not known:

• Chemical burns in neonates,
• Allergic skin disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation, and blisters.
• Corneal injury (damage to the surface of the eye) and permanent eye damage, 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 or pharmacist, 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 Menalmina

Keep the bottle in the original packaging to protect it from light. Keep the container tightly closed.

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

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

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

6. Contents of the pack and other information

Composition of Menalmina

Each millilitre of solution contains 10 mg of chlorhexidine digluconate as the active substance.

The other components (excipients) are: Purified water.

Appearance of the product and contents of the container

Clear or slightly yellow solution.

Menalmina is a cutaneous spray solution supplied in glass bottles equipped with a metering valve containing 30 ml and 60 ml of solution.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

This patient information leaflet was approved: September 2025

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu <, and on the website of the {Spanish Agency of Medicines and Health Products (AEMPS)} (http://www.aemps.gob.es/)}>.