Prospecto: Information for the User

MERCROMINA FILM 20 mg/ml Topical Solution

merbromina

Read this prospect carefully before starting to use this medicine, as it containsimportant information for you.

Follow exactly the administration instructions for the medicine contained in this prospector those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

1.What MERCROMINA FILM is and for what it is used

2.What you need to know before starting to use MERCROMINA FILM

3.How to use MERCROMINA FILM

4.Possible adverse effects

5.Storage of MERCROMINA FILM

6.Contents of the package and additional information

Contains merbromine as the active ingredient, which belongs to the group of antisepsis and disinfectant medications.

Mercromina Film is a topical antiseptic, indicated for the disinfection of superficial minor wounds, such as abrasions, cracks, or mild burns.

Do not use Mercromina Film

• If you are allergic to merbromine or to any of the other components of this medication (listed in section 6).
• In the eyes or in the nasal passages.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mercromina Film.

- Do not apply to extensive areas or with non-breathable dressings.

- Merbromine is inactivated by the presence of organic matter or serum, so it is essential to clean the wound before using it (see section 3).

- In case of accidental contact with eyes or ears, wash immediately with plenty of water.

- Do not use in the case of deep and extensive wounds.

Children

Although it has been used extensively in children, there are no specific clinical trials available for children.

Other medications and Mercromina Film

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

Mercromina Film is incompatible with acids, with alkaloid salts, with most local anesthetics, and with metals and sulfurs. Therefore, these products should not be used at the same time as merbromine. If hydrogen peroxide is applied before Mercromina Film, the affected area should be dried properly, as hydrogen peroxide would break down Mercromina Film.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It is not recommended to use Mercromina Film on large skin areas or for a prolonged period in pregnant women.

During breastfeeding, it is recommended to use Mercromina Film with caution.

Driving and operating machines

The influence of Mercromina Film on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your pharmacist.

Before applying MercrominaFilm, wash the wound carefully with water or soap and water or hydrogen peroxide; if for any reason water cannot be used to clean the affected area, use the same MercrominaFilm in sufficient quantity. Dry, especially if hydrogen peroxide was used, as it would break down the MercrominaFilm.

Using the dropper, cover the wound and its edges. Leave for a few minutes to ensure its fixation, remove the excess with gauze or cotton without touching the wound.

It is recommended to apply 2-3 times a day.

If symptoms worsen after 5 days of treatment, consult your doctor.

Use in children

Use as in adults.

If you use more MercrominaFilmthan you should

In case of excessive application on the skin, wash the area with water and soap.

In case of accidental ingestion, symptoms such as nausea, vomiting, excessive salivation, metallic taste, diarrhea, abdominal pain may occur.

The treatment of poisoning is symptomatic and supportive (antiemetic in case of nausea or vomiting, for example).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, or go to a medical center, indicating the medication and the amount ingested..

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

With a frequency that has not been established with precision, the following may occur:

In people who are allergic (hypersensitive), it may produce skin sensitization (eczema or contact dermatitis), in which case treatment should be interrupted.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging 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.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mercromina Film

• The active ingredient is merbromin. Each milliliter of solution contains 20 mg of merbromin.
• The other components (excipients) are:povidone, lauriléter polioxietilénico, and purified water.

Appearance of the product and contents of the packaging

Mercromina Film is ared-colored topical solution.

It is presented in a bottle with a dropper cap of 10 and 30 ml and in a clinical container with a dropper of 250 ml.

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12 – 08191 RUBI (Barcelona)

SPAIN

Date of the last review of this leaflet:December 2021.

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices.