Neomercurocromo - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Undesirable Effects Shelf Life and Storage

Active ingredients: Eosin, Chloroxylenol, Propylene glycol

NEOMERCUROCROMO cutaneous solution

Indications Why is Neomercurocromo used? What is it for?

NEOMERCUROCROMO is a product based on eosin, chloroxylenol and propylene glycol used in the local disinfectant treatment of wounds, abrasions, burns, bedsores and sores in general. Talk to your doctor if you don't feel better or if you feel worse after a few days.

Contraindications When Neomercurochrome should not be used

Do not use NEOMERCUROCHROME

  • if you are allergic to the active substances or any of the other ingredients of this medicine.

Precautions for use What you need to know before taking Neomercurochrome

  • Do not use for prolonged treatments; after a short period of treatment without appreciable results, consult your doctor. The use, especially if prolonged, of products for cutaneous use (local) can give rise to sensitization phenomena (excessive reaction of the organism to foreign substances with which it has come into contact). In this case, stop the treatment and consult your doctor to start a suitable therapy.
  • The product is for external use only.
  • The accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. In case of accidental ingestion consult a doctor immediately.
  • Avoid contact with eyes. It leaves stains on clothes that are difficult to remove.

Interactions Which drugs or foods can modify the effect of Neomercurochrome

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid the simultaneous use of other disinfectants and detergents.

NEOMERCUROCROMO with food, drink and alcohol

There are no known interactions.

Warnings It is important to know that:

Pregnancy and breastfeeding

The medicine can be used during pregnancy. If you are unsure, ask your doctor or pharmacist for advice before using the medicine.

If you are breast-feeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

It doesn't interfere. The container of NEOMERCUROCROMO contains latex rubber The container of this medicine is made of latex rubber. It can cause severe allergic reactions.

Dose, Method and Time of Administration How to use Neomercurochrome: Posology

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Apply a few drops of cutaneous solution on the injured part 1-2 times a day; cover with an appropriate dry sterile bandage if necessary.

Do not exceed the recommended dose.

Side Effects What are the side effects of Neomercurochrome

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is possible, in some cases, the occurrence of burning or irritation (intolerance), however without consequences, which does not require modification of the treatment. For repeated applications or following a bandage that does not allow the transpiration of the treated part, there may be inflammation of the skin (eczematous reactions). The use of the medicine can give rise to phenomena of sensitivity to the sun and UV rays (photosensitization).

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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

This medicinal product does not require any special storage temperatures. Keep the bottle tightly closed, away from heat sources.

Do not use this medicine after the expiry date which is stated on the carton after "Expiry". The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other information

What NEOMERCUROCROMO contains

The active ingredients contained in 100 ml of cutaneous solution are: Eosin 2.0 g; Chloroxylenol 0.3 g; Propylene glycol 30.0 g.

The other ingredients are: Ethanol 95 °; sodium edetate; Purified water.

Description of the appearance of NEOMERCUROCROMO and contents of the pack

NEOMERCUROCROMO is presented as a cutaneous solution, 1 bottle of 50 ml with glass dropper.

The medicine is also available in packs of 2 bottles of 10 ml with a plastic dropper spout.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Neomercurochrome can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

NEOMERCUROCHROME

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 ml contain:

- Eosin 2.0 g

- Chloroxylenol 0.3 g

- Propylene glycol 30.0 g

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Skin solution.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Local disinfectant treatment of wounds, abrasions, burns, bedsores and sores in general.

04.2 Posology and method of administration

Dosage

Apply a few drops 1-2 times a day on the injured part. Do not exceed the recommended dose.

Method of administration

Apply the cutaneous solution on the injured part and cover with an appropriate dry sterile bandage if necessary.

04.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

04.4 Special warnings and appropriate precautions for use

The product is for external use only.

The use, especially prolonged, of products for topical use can give rise to sensitization phenomena, in this case stop the treatment and consult the doctor to establish a suitable therapy.

Do not use for prolonged treatments; after a short period of treatment without appreciable results, consult your doctor. The accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. Avoid contact with eyes. The medicine leaves hard-to-remove stains on clothing.

The 50 ml Neomercurochrome container contains latex rubber.

It can cause severe allergic reactions.

04.5 Interactions with other medicinal products and other forms of interaction

Avoid the simultaneous use of other antiseptics and detergents.

04.6 Pregnancy and breastfeeding

Pregnancy

Eosin, chloroxylenol and propylene glycol are not expected to cause effects during pregnancy, since systemic exposure to eosin, chloroxylenol and propylene glycol is negligible.

Neomercurocromo can be used during pregnancy.

04.7 Effects on ability to drive and use machines

Not relevant.

04.8 Undesirable effects

In some cases, intolerance (burning or irritation) may occur, however without consequences, which does not require modification of the treatment. For repeated application or following occlusive dressing, eczematous skin reactions may occur. The solution can give rise to photosensitization phenomena.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose

On the basis of experimental studies conducted on animals, presumably even with the ingestion of 600 ml (twelve bottles of 50 ml) there would be no significant toxic effects.

However, in case of accidental ingestion of the preparation, since a specific antidote is not known, perform gastric lavage as an immediate intervention; if a certain period of time has elapsed, administer activated charcoal.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: antiseptics and disinfectants (Phenol and derivatives).

ATC code: D08AE05.

Mechanism of action

Eosin is a molecule used in dermatological therapy with a bacteriostatic action on gram-positive bacteria and Candida and a strong anti-exudant activity which, by reducing secretion, accelerates the re-epithelialization and healing of the injured skin. Chloroxylenol is a broad spectrum bactericide effective against numerous gram-positive, gram-negative bacteria and some fungi. Propylene glycol combines its antibacterial and antifungal properties with a humectant and keratolytic action that allows greater penetration of the active ingredients inside the lesion.

Clinical efficacy and safety

Neomercurocromo was active against gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes, Propionibacterium acnes, Corynebacterium xerosis), gram-negative bacteria (Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae), fungi (Candida albicans).

Clinical tests of irritability and photosensitization on intact skin carried out on 40 healthy volunteers gave negative results in each case. Clinical trials, aimed at evaluating the efficacy of Neomercurocromo in the treatment of skin infections and in pre and post-operative disinfection, have always confirmed a high local tolerability of the preparation.

05.2 Pharmacokinetic properties

Not relevant.

05.3 Preclinical safety data

Neomercurocromo has a very low toxicity. Orally, chloroxylenol has a LD50 of 3.83 g / kg in rats; per os, eosin has a LD50 of 2.34 g / kg in rats and 5.0 g / kg in guinea pigs; propylene glycol per os has a LD50 of 30 g / kg in rats. Animal experiments have shown that Neomercurocromo is well tolerated by abraded skin, has no sensitizing capacity, does not hinder cicatrization, on the contrary it reduces the amount of exudate, accelerating the reparative processes.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

95 ° ethanol; sodium edetate; purified water.

06.2 Incompatibility

Incompatible with acids, cationic substances, non-ionic surfactants, methylcellulose.

06.3 Period of validity

3 years.

06.4 Special precautions for storage

This medicinal product does not require any special storage temperatures.

Keep the bottle tightly closed, away from heat sources.

06.5 Nature of the immediate packaging and contents of the package

50 ml amber glass bottle with polypropylene cap and glass dropper.

10 ml polyethylene bottle with polyethylene dropper spout and polypropylene cap.

Not all pack sizes may be marketed.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

Pharmaceutical Laboratory SIT S.r.l.

Via Cavour, 70

27035 Mede (PV)

08.0 MARKETING AUTHORIZATION NUMBER

Neomercurochrome cutaneous solution, 1 bottle of 50 ml AIC: 032246047

Neomercurocromo cutaneous solution, 2 bottles of 10 ml AIC: 032246062

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of first authorization: 10 June 1996

Date of most recent renewal: 10 December 2012

10.0 DATE OF REVISION OF THE TEXT

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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