Active ingredients: liquid phenol, basic fuchsin, resorcinol, boric acid
Fuchsin Phenic Cutaneous solution
Why is Phoenician fuchsin used? What is it for?
Pharmacotherapeutic category
Topical antifungals.
Therapeutic indications
Treatment of cutaneous mycoses.
Contraindications When Phoenician fuchsin should not be used
Hypersensitivity to the active substance or to any of the excipients;
Injured or inflamed tissues;
Children under 3 years of age.
Precautions for use What you need to know before taking Phoenician fuchsin
For the presence of boric acid, do not administer to children under 3 years of age and do not apply to injured or inflamed tissues.
Phenol is a poison, it must not be ingested. Avoid prolonged treatments.
The use, especially if prolonged, can give rise to phenomena of irritation or sensitization. If this occurs, stop the treatment. Do not apply near the eyes and mucous membranes.
Interactions Which drugs or foods can modify the effect of Phoenician fuchsin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
There are no known interactions with other drugs.
Warnings It is important to know that:
The basic fuchsin also colors the skin in a deep red. Any stains on objects and clothing can be removed with a 1% sodium carbonate solution in 70% alcohol (70 °).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In the absence of specific studies, the medicine should be used during pregnancy and lactation only in case of need and under direct medical supervision.
Effects on ability to drive and use machines
The medicine does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Phoenician fuchsin: Dosage
External use.
Apply 1-2 times a day with brushing or touching on the area to be treated.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Overdose What to do if you have taken an overdose of Phoenician fuchsin
After application of the preparation on large skin surfaces, there may be cases of skin irritation and intolerance due to overdose.
Occlusive applications (compresses) can cause necrotic phenomena as well as manifestations due to systemic absorption of phenol, resorcinol and boric acid (urine staining, dizziness, headache, hyperhidrosis, hypothermia, convulsions and coma).
Phenol is a toxic substance whose absorption through the skin in high quantities and especially for a prolonged time can produce local (skin irritation and sensitization) and systemic toxicity, especially at the level of the CNS, heart, blood vessels, lungs and kidneys.
Prolonged use can cause myxedema due to the antithyroid action of resorcinol.
In case of accidental ingestion / intake of an excessive dose of Marco Viti Phoenician Fuchsin, notify your doctor immediately or contact the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF FUCSINA FENICA MARCO VITI, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Phoenician fuchsin
Like all medicines, Phoenician fuchsin can cause side effects, although not everybody gets them.
The following are the side effects of Phoenician fuchsin. Insufficient data are available to establish the frequency of the individual effects listed.
Skin and subcutaneous tissue disorders
Skin irritation.
Disorders of the immune system
Awareness raising.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
After first opening, the residual medicine should be used within 6 months. After this period, the residual medicinal product must be discarded.
WARNING: do not use the medicine after the expiry date indicated on the package.
Conservation conditions
Keep the container tightly closed in the original package to protect the medicine from light
Medicines should not be disposed of down the drain or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
Composition
100 g of solution contain
Active ingredients: Phenol 4.0 g of liquid phenol (equal to 3.4 g of phenol)
Basic fuchsin 0.3 g
Resorcinol 10 g
Boric acid 1 g
Excipients: purified water, ethanol, acetone.
Pharmaceutical Form and Content
Skin solution. Bottle of 25 g.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
FUCSINA FENICA ZETA SKIN SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of solution contain
Active principles:
Liquid phenol 4.0 g equal to 3.4 g of phenol
Basic fuchsin 0.3 g
Resorcinol 10 g
Boric acid 1 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
Treatment of cutaneous mycoses.
04.2 Posology and method of administration
External use.
Apply 1-2 times a day with brushing or touching on the area to be treated.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients;
Injured or inflamed tissues;
Children under 3 years of age.
04.4 Special warnings and appropriate precautions for use
For the presence of boric acid, do not administer to children under 3 years of age and do not apply to injured or inflamed tissues.
Phenol is a poison, it must not be ingested. Avoid prolonged treatments.
The use, especially if prolonged, can give rise to phenomena of irritation or sensitization. If this occurs, interrupt the treatment.
Do not apply near the eyes and mucous membranes.
The basic fuchsin also colors the skin in a deep red. Any stains on objects and clothing can be removed with a 1% sodium carbonate solution in 70% alcohol (70 °).
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions with other drugs.
04.6 Pregnancy and lactation
In the absence of specific studies, the medicine should be used during pregnancy and breastfeeding only in case of need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
Carbolic Fuchsin Zeta does not affect the ability to drive or use machines.
04.8 Undesirable effects
The following are the side effects of Phoenician fuchsin, organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed.
Skin and subcutaneous tissue disorders
Skin irritation.
Disorders of the immune system
Awareness raising.
04.9 Overdose
After application of the preparation on large skin surfaces, there may be cases of skin irritation and intolerance due to overdose.
Occlusive applications (compresses) can cause necrotic phenomena as well as manifestations due to systemic absorption of phenol, resorcinol and boric acid (urine staining, dizziness, headache, hyperhidrosis, hypothermia, convulsions and coma).
Phenol is a toxic substance whose absorption through the skin in high quantities and especially for a prolonged time can produce local (skin irritation and sensitization) and systemic toxicity, especially at the level of the CNS, heart, blood vessels, lungs and kidneys.
Prolonged use can cause myxedema due to the antithyroid action of resorcinol.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antifungals for topical use.
ATC code: D01AE20.
The medicine is a "combination of basic fuchsin, phenol, boric acid, resorcinol. Phenol is an antiseptic active above all on the germs of fermentation and putrefaction, not very effective on the spores. It also has anti-itching and local anesthetic action. The basic fuchsin is endowed with of a marked antifungal activity, especially towards dermatophytes.It is also active against Gram + type bacteria. Resorcinol has an antiseptic activity comparable to that of phenol and keratolytic activity. Boric acid has bacteriostatic-fungistatic activity.
05.2 "Pharmacokinetic properties
Phenol and resorcinol are absorbed through the skin and mucous membranes. Phenol is metabolized to phenylglucuronide and phenisulfate, small amounts are oxidized to catechols and quinones. The metabolites are excreted in the urine. Resorcinol is also excreted in the urine.
Boric acid is poorly absorbed through normal skin but easily penetrates through broken skin. After absorption approximately 50% is excreted in the urine within 12 hours. The remainder is probably excreted within 3 to 7 days.
Basic fuchsin is not absorbed systemically.
05.3 Preclinical safety data
There are no preclinical studies performed directly with the medicine.
Fuchsin was neither toxic nor mutagenic.
Resorcinol in animal toxicity studies has shown low toxicity.
Resorcinol is neither mutagenic nor carcinogenic and the product has generally been shown to be non-irritating or photo-allergenic on the skin.
Available data for boric acid show that the product is neither mutagenic nor carcinogenic.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Purified water, ethanol, acetone.
06.2 Incompatibility
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
06.3 Period of validity
5 years.
Validity after first opening: 6 months.
06.4 Special precautions for storage
Keep the container tightly closed in the original package to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
Glass bottle of 30 ml
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Zeta Farmaceutici S.p.A.
Via Mentana, 38
36100 Vicenza
08.0 MARKETING AUTHORIZATION NUMBER
031326010
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: December 1993
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 23 April 2012
