MENALMINA 10 MG/ML CUTANEOUS SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Menalmina 10 mg/ml cutaneous solution

chlorhexidine digluconate

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

Always follow exactly the instructions for use provided in this leaflet or as directed 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 should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of this leaflet

1. What Menalmina 10 mg/ml cutaneous solution is and what it is used for
2. What you need to know before using Menalmina 10 mg/ml cutaneous solution
3. How to use Menalmina 10 mg/ml cutaneous solution
4. Possible adverse effects
5. How to store Menalmina 10 mg/ml cutaneous solution
6. Contents of the pack and other information

1. What Menalmina 10 mg/ml cutaneous solution is and what it is used for

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

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

2. What you need to know before using Menalmina 10 mg/ml cutaneous solution

Do not use Menalmina 10 mg/ml cutaneous solution:

• If you are allergic to chlorhexidine digluconate or to any of the other ingredients of this medicine (listed in section 6).

• In the ears, especially if the tympanic membrane is damaged.

Warnings and precautions

Consult your doctor or pharmacist before using Menalmina 10 mg/ml cutaneous solution.

• This medicine is for external use on the skin only. Do not ingest.

• Avoid contact with the ears, inside of the mouth, or other mucous membranes. In case of accidental contact, rinse immediately with plenty of water.

• Menalmina 10 mg/ml cutaneous solution must not come into contact with the eyes due to the risk of visual damage. If contact occurs, wash immediately and thoroughly with water. In case of irritation, redness or eye pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (damage to the surface of the eye) have been reported, which could eventually 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 case of deep or extensive wounds without consulting a doctor.

• Must not be applied repeatedly, nor used over large areas of skin, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.

• Must not be used for antisepsis of puncture or injection sites, or for disinfection of surgical instruments.

• Menalmina 10 mg/ml cutaneous solution may cause chemical burns on the skin. Do not use large amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking bed linens or other wet materials in direct contact with the patient.

Children

Use with caution in neonates, especially those born before week 32 of gestation and during the first weeks of life.

Other medicines and Menalmina 10 mg/ml cutaneous solution

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The simultaneous or consecutive use of multiple antiseptics should be avoided.

Must not be used in combination with, or after application of, anionic soaps, iodine, heavy metal salts, or acids.

Pregnancy, breastfeeding and fertility

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.

There are no known risks associated with the use of Menalmina 10 mg/ml cutaneous solution 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. Menalmina 10 mg/ml cutaneous solution may be used during pregnancy or breastfeeding. Breastfeeding women should avoid applying it to the breasts.

Driving and use of machines

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

3. How to use Menalmina 10 mg/ml cutaneous solution

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For external use only.

It is recommended to clean and dry the wound before applying Menalmina 10 mg/ml cutaneous solution. Apply directly to the affected area, or using a gauze dressing, once or twice daily, using sufficient product to cover the entire wound surface.

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

If you use more Menalmina 10 mg/ml cutaneous solution than you should

In case of accidental ingestion, perform gastric lavage and protect the gastric mucosa. Seek medical attention at a healthcare facility and/or call the National Toxicology Service at Tel. 91 562 04 20, indicating the product and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Stop using Menalmina 10 mg/ml cutaneous solution and inform your doctor immediately if you experience a severe allergic reaction.

The frequency of these adverse effects is not known (cannot be estimated from the 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 adverse effects of unknown frequency:

-Chemical burns in neonates, allergic reactions, and skin reactions (pruritus, erythema, skin rash, urticaria, dermatitis).

-Corneal injury (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 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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Menalmina 10 mg/ml cutaneous solution

Keep in the original packaging to protect from light.

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 “EXP”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a pharmacy’s SIGRE collection point. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Menalmina 10 mg/ml cutaneous solution

• The active substance is chlorhexidine digluconate. Each ml contains 10 mg of chlorhexidine digluconate. The excipient is purified water.

Additional information

Clothing that has been in contact with this medicinal product should not be washed with bleach or other hypochlorites, as this would result in a brownish discoloration of the fabrics. Instead, it should be washed with domestic detergents based on sodium perborate.

Appearance of the product and contents of the container

Clear or slightly yellow solution.

It is presented in a 40 ml plastic bottle (provided with a dropper and screw cap) or in 10 single-dose units of 3 ml.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIO REIG JOFRE, SA
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona) Spain

Date of the most recent review of this leaflet: July 2024

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.