MERCROMINA FILM 20 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet: information for the user

MERCROMINA FILM 20 mg/ml cutaneous solution

merbromin

Read the entire leaflet carefully before starting to use this medication, as it containsimportant information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the leaflet

1. What MERCROMINA FILM is and what it is used for
2. What you need to know before starting to use MERCROMINA FILM
3. How to use MERCROMINA FILM
4. Possible side effects
5. Storage of MERCROMINA FILM
6. Package contents and additional information

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

It contains merbromin as the active ingredient, which belongs to the group of antiseptic and disinfectant medications.

Mercromina Film is a cutaneous antiseptic, indicated for the disinfection of small superficial wounds, such as scrapes, cracks, or minor burns.

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

Do not useMercromina Film

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

Warnings and precautions

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

• Do not apply to large areas or with non-breathable dressings.
• Merbromin is inactivated by the presence of organic matter or serum, so it is essential to clean the wound before use (see section 3).
• In case of accidental contact with eyes or ears, rinse immediately with plenty of water.
• It should not be used in the case of deep and extensive wounds.

Children

Although it has been widely used in children, there are no specific clinical trials in children.

Other medications andMercromina Film

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

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

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.

The use of Mercromina Film is not recommended on large areas of skin or for an extended period in pregnant women.

During breastfeeding, the use of Mercromina Film is advised with caution.

Driving and using machines

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

3. How to use MERCROMINA FILM

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your pharmacist.

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

With the dropper, cover the wound and its edges. Let it sit for a few minutes to ensure its fixation, then 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.

Treatment for 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 Toxicology Information Service, phone: 91 562 04 20, or go to a medical center, indicating the medication and the amount ingested.

4. Possible side effects

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

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

In allergic (hypersensitive) individuals, skin sensitization (eczema or contact dermatitis) may occur, in which case treatment should be discontinued.

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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of MERCROMINA FILM

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. 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 packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of MercrominaFilm

• The active ingredient is merbromin. Each ml of solution contains 20 mg of merbromin.
• The other components (excipients) are: povidone, laureth-9 polyoxyethylene, and purified water.

Appearance of the product and package contents

Mercromina Film is a cutaneous solution, red in color.

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

Marketing authorization holder and manufacturer

LAINCO, S.A.

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

SPAIN

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

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products.