Product Information for the Patient

Menalmina 10 mg/ml Topical Solution

Chlorhexidine Digluconate

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this product information or those indicated by your doctor or pharmacist.

• Keep this product information, as you may need to refer to 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 not listed in this product information. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

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

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

Do not use Menalmina 10 mg/ml topical 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 Menalmina 10 mg/ml topical solution.

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

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

-Menalmina 10 mg/ml topical 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. In case of eye irritation, redness, or pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which could 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).

-Do not use in case of deep and extensive wounds without consulting a doctor.

-Do not apply repeatedly, or use on large areas, with occlusive dressing (non-breathable), on injured skin, and in mucous membranes.

-Do not use for the asepsis of puncture or injection sites, or for the disinfection of surgical equipment.

-Menalmina 10 mg/ml topical solution may cause chemical burns on the skin. Do not use large quantities and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak through bedclothes or other wet materials in direct contact with the patient.

Children

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

Other medications and Menalmina 10 mg/ml topical solution

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

It is advisable to avoid the use of multiple antiseptics at the same time or in succession.

Do not use in combination with 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.

No known risks exist with the use of Menalmina 10 mg/ml topical solution during pregnancy or breastfeeding. The excretion of chlorhexidine digluconate or any of its metabolites in breast milk is unknown. No effects are anticipated during pregnancy, in newborns, or in lactating women, as systemic exposure to chlorhexidine is insignificant. Menalmina 10 mg/ml topical solution may be used during pregnancy or breastfeeding. Lactating women should avoid using it on their breasts.

Driving and operating machinery

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

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

External use.

Clean and dry the wound before applying Menalmina 10 mg/ml topical solution. Apply directly to the affected area, or through a gauze, one or two times a day, applying sufficient product to cover the entire surface of the wound.of the wound.

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

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

The frequency of these adverse effects 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 that may appear red and painful and/or cause difficulty swallowing.

- Chest pain.

- Red patches on the skin.

These may be signs of an allergic reaction.

Other adverse effects of unknown frequency:

- Chemical burns in newborns, 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 (following accidental eye exposure during surgical interventions 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 or pharmacistorpharmacist,even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store 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 that appears on the label of the container after “CAD”. 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 the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Menalmina 10 mg/ml topical 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 this would cause a brownish discoloration of the fabric, but rather with domestic detergents based on sodium perborate.

Appearance of the product and contents of the packaging

Transparent or slightly yellowish solution.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIO REIG JOFRE, SA

Gran Capitán,10 08970 Sant Joan Despí (Barcelona) Spain

Date of the last review of this leaflet:July 2024

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