MENALMINA 10 mg/ml CUTANEOUS SOLUTION

2. What you need to know before starting to use Menalmine 10 mg/ml cutaneous solution

Do not use Menalmine 10 mg/ml cutaneous solution:

-If you are allergic to chlorhexidine digluconate or any of the other components of this medication (listed in section 6).

-In the ears, especially if the eardrum is damaged.

Warnings and precautions

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

-This medication is for external use on the skin only. Do not ingest.

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

-Menalmine 10 mg/ml 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 pain in the eyes, 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 (induced deep sleep).

-It should not be used in case of deep and extensive wounds without consulting a doctor.

-It should not be applied repeatedly, nor used on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.

-It should not be used for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.

-Menalmine 10 mg/ml cutaneous solution may cause chemical burns on the skin. Do not use large amounts and avoid the solution accumulating in skin folds, under the patient, or soaking sheets or other wet material in direct contact with the patient.

Children

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

Other medications and Menalmine 10 mg/ml cutaneous solution

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The use of several antiseptics at the same time or in succession should be avoided.

It should not be used in combination or after the application of anionic soaps, iodine, heavy metal salts, and acids.

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 medication.

There are no known risks associated with the use of Menalmine 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 babies, as systemic exposure to chlorhexidine is insignificant. Menalmine 10 mg/ml cutaneous solution can be used during pregnancy or breastfeeding. Breastfeeding women should avoid using it on their breasts.

Driving and using machines

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

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

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

External use.

It is recommended to clean and dry the wound before applying Menalmine 10 mg/ml cutaneous solution. Apply directly to the affected area, or using a gauze, one or two times a day, applying enough product to cover the entire surface of the wound.

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

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

In case of accidental ingestion, proceed with gastric lavage and protection of the gastric mucosa. Go to a medical center and/or call the National Toxicology Service Tel. 91 562 04 20, indicating the product and the amount ingested.

4. Possible side effects

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

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

The frequency of these side effects is unknown (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 that 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 side effects of unknown frequency:

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

-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 (induced deep sleep).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Menalmine 10 mg/ml cutaneous solution

Keep in the original packaging to protect it from light.

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

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

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. 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 Menalmine 10 mg/ml cutaneous solution

-The active ingredient is chlorhexidine digluconate. Each ml contains 10 mg of chlorhexidine digluconate. The excipient is purified water.

Additional information

Clothing that has come into contact with this medication should not be washed with bleach or other hypochlorites, as it may cause a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.

Appearance of the product and package contents

Transparent or slightly yellowish solution.

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

Only some package 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 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.