Mercromina Film 20 mg/ml cutaneous solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
MERCROMINA FILM 20 mg/ml cutaneous solution
merbromine
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 5 days.
Contents of this leaflet
- What MERCROMINA FILM is and what it is used for
- What you need to know before using MERCROMINA FILM
- How to use MERCROMINA FILM
- Possible adverse effects
- How to store MERCROMINA FILM
- Contents of the pack and other information
1. What MERCROMINA FILM is and what it is used for
It contains as its active substance merbromine, which belongs to the group of antiseptic and disinfectant medicines.
Mercromina Film is a topical antiseptic indicated for the disinfection of minor superficial wounds, such as scrapes, cracks, or mild burns.
2. What you need to know before using MERCROMINA FILM
Do not use Mercromina Film
- If you are allergic to merbromine or to any of the other ingredients of this medicine (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 on large skin areas or under occlusive (non-breathable) dressings.
- Merbromine is inactivated by the presence of organic matter or serum; therefore, it is important to clean the wound before use (see section 3).
- In case of accidental contact with eyes or ears, rinse immediately with plenty of water.
- Should not be used for deep or extensive wounds.
Children
Although Mercromina Film has been widely used in children, specific clinical trials in pediatric populations are lacking.
Other medicines and Mercromina Film
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Mercromina Film is incompatible with acids, alkaloid salts, most local anesthetics, and metals and sulfides. Therefore, these products should not be used simultaneously with merbromine. If hydrogen peroxide is used before Mercromina Film, the affected area must be properly dried, as hydrogen peroxide would decompose Mercromina Film.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Mercromina Film over large skin areas or for prolonged periods is not recommended in pregnant women.
During breastfeeding, the use of Mercromina Film is advised with caution.
Driving and using machines
The effect of Mercromina Film on the ability to drive and operate machinery is none or negligible.
3. How to use MERCROMINA FILM
Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your pharmacist.
Before applying Mercromina Film, wash the wound carefully with water, soapy water, or hydrogen peroxide. If for any reason water cannot be used to clean the affected area, use Mercromina Film itself in sufficient quantity. Dry thoroughly, especially if hydrogen peroxide was used, as it would otherwise break down the Mercromina Film.
Using the dropper, cover the wound and its edges. Leave for a few minutes to ensure proper adhesion, then remove any excess with gauze or cotton without touching the wound.
It is recommended to apply 2–3 times daily.
If symptoms worsen after 5 days of treatment, consult your doctor.
Use in children
Use as in adults.
If you use more Mercromina Film than you should
In case of excessive application to the skin, wash the area with water and soap.
In case of accidental ingestion, symptoms such as nausea, vomiting, excessive salivation, metallic taste, diarrhea, and abdominal pain may occur.
Treatment of poisoning is symptomatic and supportive (for example, antiemetics in case of nausea or vomiting).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number: 91 562 04 20, or go to a medical center, stating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
With a frequency that could not be precisely determined, the following may occur:
In allergic (hypersensitive) individuals, skin sensitization (eczema or contact dermatitis) may occur; if this happens, treatment should be discontinued.
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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of MERCROMINA FILM
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of MercrominaFilm
- The active substance is merbromine. Each ml of solution contains 20 mg of merbromine.
- The other components (excipients) are: povidone, polyoxyethylene lauryl ether, and purified water.
Appearance of the product and contents of the container
Mercromina Film is a red cutaneous solution.
It is available in 10 ml and 30 ml bottles with dropper cap, and in a 250 ml clinical pack with dropper.
Marketing Authorization Holder and Manufacturer
LAINCO, S.A.
Avda. Bizet, 8-12 – 08191 RUBI (Barcelona)
SPAIN
Date of the most recent revision of this leaflet: December 2021.
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices