Active ingredients: Bifonazole
AZOLMEN 1% cream
AZOLMEN 1% gel
AZOLMEN 1% cutaneous solution
AZOLMEN 1% cutaneous powder
Azolmen package inserts are available for pack sizes: - AZOLMEN 1% cream, AZOLMEN 1% gel, AZOLMEN 1% cutaneous solution, AZOLMEN 1% cutaneous powder
- AZOLMEN 1% skin foam
Why is Azolmen used? What is it for?
AZOLMEN contains bifonazole and is a broad spectrum antifungal (antifungal) that acts against infections sustained by dermatophytes (parasitic skin fungi), saccharomycetes (yeasts), molds and other pathogenic fungi such as eg. Malassezia furfur.
Azolmen 1% cream, Azolmen 1% gel, Azolmen 1% cutaneous solution are used in the treatment of dermatomycosis (skin diseases caused by fungi) caused by dermatophytes, saccharomycetes (e.g. Candida) and other pathogenic fungi (e.g. Malassezia furfur). They are also used in dermatoses (non-inflammatory skin diseases) from superinfections sustained by the aforementioned pathogenic fungi and by bacteria sensitive to AZOLMEN.
These diseases include: plantar and interdigital mycosis of the hand and foot (athlete's foot); onychomycosis (nail disease caused by pathogenic fungi), mycosis of the trunk and skin folds (skin), pityriasis versicolor.
Azolmen 1% cutaneous powder is indicated for the treatment of moist mycoses of the skin and skin folds, especially if localized in areas usually covered or poorly ventilated (for example: bandage dermatitis, interdigital mycosis), as well as in addition to treatment with Azolmen 1% cream, Azolmen 1% gel and Azolmen 1% cutaneous solution.
Talk to your doctor if you do not feel better or if you feel worse after 2 - 4 weeks.
Contraindications When Azolmen should not be used
Do not use AZOLMEN
If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before you take Azolmen
Talk to your doctor or pharmacist before using Azolmen.
Do not use the medicine for longer than indicated in section 3 "How to use Azolmen".
The use, especially prolonged, of medicines for topical (local) use, can give rise to sensitization phenomena (complex of phenomena that are produced in the body by the action of certain substances and that lead to a particular reactivity towards them) . In this case it is necessary that you stop the treatment and your doctor will prescribe a suitable therapy. The same must be done in the event of the development of resistant microorganisms (ie that no longer respond to the drug).
Children
The medicine should be used only in case of real need and under the direct supervision of the doctor.
Interactions Which drugs or foods can modify the effect of Azolmen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known interactions of bifonazole with other drugs.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Use this medicine only when clearly needed and under the direct supervision of your doctor
Driving and using machines
AZOLMEN does not affect the ability to drive and use machines.
AZOLMEN cream contains cetylstearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Dose, Method and Time of Administration How to use Azolmen: 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.
For the purpose of a complete recovery it is essential that you strictly follow the instructions in this leaflet and use the medicine for the period necessary to treat the disease.
Do not interrupt the therapy immediately after the disappearance of the acute inflammatory (inflammatory) manifestations and symptoms but you must adhere to the following average treatment times, depending on the type of infection, the extent and location of the infection itself:
- Tinea pedis (athlete's foot) 3 weeks
- Tinea corporis, tinea manuum, tinea cruris (fungal skin infections affecting the body, hand and groin respectively) 2- weeks
- Pityriasis versicolor (fungal infection manifesting as milky-coffee-colored spots, usually located on the trunk) 2 weeks
- Superficial skin candidiasis (fungal skin infection) 2- weeks
The treatment times indicated in brackets refer to types of infection, in the opinion of the doctor, particularly extensive or resistant.
Azolmen 1% cream and Azolmen 1% gel
They are particularly suitable for the treatment of uncovered areas of the skin.
Unless otherwise prescribed, apply a small amount of product (e.g. 1 or 2 cm) once a day, preferably in the evening before bedtime, to cover an area the size of a palm of your hand, making a light massage on the parts infected.
These products are odorless, do not stain and can be easily removed with water.
Azolmen 1% gel, thanks to the refreshing power of its components, is particularly useful in cases where an inflammatory component with a burning sensation and / or skin itching is associated with the current infection.
Azolmen 1% cutaneous solution
It is especially useful for treating hair-covered skin areas as well as fungal infections in the skin folds, with the exception of the mucous membranes. Unless otherwise prescribed, apply only once a day, preferably in the evening before going to bed, a small amount of product sufficient to cover an area the size of a palm of your hand, making a light massage on the infected parts.
This product is odorless, does not stain and can be easily removed with water.
Azolmen 1% cutaneous powder
Sprinkle the affected parts of the skin with the powder one or more times a day according to the degree of humidity and the location of the mycosis.
On the advice of the doctor, the product can be applied as an addition to the treatment with Azolmen 1% cream, Azolmen 1% gel or Azolmen 1% cutaneous solution (for example: skin powder in the morning, cream, gel or skin solution in the evening).
In case of tinea pedis, you can sprinkle Azolmen 1% cutaneous powder in shoes and socks also in order to eliminate the damp conditions and to prevent the infection from returning.
Overdose What to do if you have taken too much Azolmen
No toxic effects of the drug have been reported related to the intake of an excessive dose.
AZOLMEN acts only locally; the absorption of the product at the systemic level (throughout the organism) is negligible.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Azolmen
Like all medicines, this medicine can cause side effects, although not everybody gets them.
AZOLMEN is generally well tolerated.
Only in rare cases can a slight and mostly transient reddening of the skin occur and more rarely a sense of burning and irritation, which usually disappear quickly.
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 through the "Agenzia Italiana del Farmaco" at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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.
No special storage precautions are required.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored.
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.
What AZOLMEN contains
Azolmen 1% cream
100 g of cream contain:
Active principle: bifonazole 1 g.
Other components: sorbitan monostearate, polysorbate 60, spermaceti, cetylstearyl alcohol, octyldodecanol, benzyl alcohol, purified water
Azolmen 1% gel
100 g of gel contain:
Active principle: bifonazole 1 g.
Other components: mixture of ethoxylated fatty alcohols, ethoxylated fatty acid glycerides, isopropylisostearate, ethanol, lactic acid, benzyl alcohol, purified water.
Azolmen 1% cutaneous solution
100 ml of solution contain:
Active principle: bifonazole 1 g.
Other components: ethanol, isopropyl myristate.
Azolmen 1% cutaneous powder
100 g of powder contain:
Active principle: bifonazole 1 g.
Other components: non-gellable rice starch
What AZOLMEN looks like and contents of the pack
1% Cream: 30 g tube, glossy white cream.
1% Gel: 30 g tube, transparent gel.
1% Cutaneous solution: bottle of 30 ml, clear colorless or pale yellow solution.
1% Skin powder: 30g bottle, white odorless powder.
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
AZOLMEN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cream
100 g of cream contain:
Active ingredient: bifonazole 1 g.
Excipient with known effect: cetylstearyl alcohol.
Gel
100 g of gel contain:
Active ingredient: bifonazole 1 g.
Skin solution
100 mL of solution contain:
Active ingredient: bifonazole 1 g.
Skin powder
100 g of powder contain:
Active ingredient: bifonazole 1 g.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream, gel, skin solution, skin powder.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cream, gel and skin solution
Dermatomycosis sustained by dermatophytes (eg ringworms), saccharomyces (eg Candida) and other pathogenic fungi (eg Malassezia furfur). Superinfection dermatosis sustained by the aforementioned pathogenic fungi and by germs sensitive to Azolmen.
Among these diseases are included plantar and interdigital mycosis of the hand and foot (athlete's foot); onychomycosis, mycosis of the trunk and skin folds, pityriasis versicolor.
Skin powder
Azolmen powder is indicated for the treatment of moist mycoses of the skin and skin folds, especially if localized in areas usually covered or poorly ventilated (for example: bandage dermatitis, interdigital mycosis) as well as as an adjunct to treatment with Azolmen cream, gel and skin solution. .
04.2 Posology and method of administration
Cream, gel and skin solution
Unless otherwise prescribed by a doctor, Azolmen should be applied in small quantities to the infected parts with a light massage once a day, preferably in the evening before going to bed.
Azolmen cream and gel are electively indicated for the treatment of uncovered skin areas.
Azolmen gel, thanks to the refreshing power of its components, is particularly useful in cases where an inflammatory component with a burning sensation and / or skin itching is associated with the current infection.
Given the high activity of Azolmen, the application of a small amount (eg ½ cm of cream or gel) is usually sufficient to cover a palm-sized surface.
Azolmen cutaneous solution is especially useful for the treatment of hair-covered skin areas as well as fungal infections in the skin folds, with the exception of the mucous membranes.
Azolmen cream, gel and skin solution is odorless, does not stain and can be easily removed with water.
For a complete recovery, the controlled and sufficiently prolonged use of Azolmen is essential.
It is advisable not to interrupt therapy immediately after the disappearance of the acute inflammatory manifestations and subjective symptoms, but to adhere to the following average treatment times, depending on the type of infection, the extent and location of the infection itself:
The treatment times indicated in brackets refer to forms, in the opinion of the doctor, particularly extensive or resistant.
Skin powder
The affected parts of the skin can be sprinkled with the powder, one or more times a day, depending on the degree of humidity and the location of the mycosis.
Azolmen cutaneous powder can, on the advice of the doctor, be applied as an adjuvant to the cream, gel or cutaneous solution (for example: powder in the morning, cream, gel or cutaneous solution in the evening).
Azolmen cutaneous powder can be sprinkled, in case of tinea pedis, in shoes and socks also in order to eliminate damp conditions and to avoid reinfection.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of medicines for cutaneous use, can give rise to sensitization phenomena; in this case, it is necessary to interrupt the treatment and institute a suitable therapy.
The same will be done in case of development of resistant microorganisms.
Pediatric population
In very early childhood, the medicine should be used only in case of real need and under the direct supervision of the doctor.
Important information about some of the ingredients:
AZOLMEN cream contains cetylstearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)
04.5 Interactions with other medicinal products and other forms of interaction
No interactions of bifonazole with other medicinal products or other forms of interaction have been reported in the literature.
04.6 Pregnancy and lactation
In pregnant women, the medicine should only be used when clearly needed and under the direct supervision of a doctor.
04.7 Effects on ability to drive and use machines
Azolmen does not affect the ability to drive and use machines.
04.8 Undesirable effects
Azolmen cream, gel, solution and powder is perfectly tolerated.
Only in rare cases may a slight and mostly transient redness of the skin arise and more rarely a sense of burning and irritation which usually disappear quickly.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
There are no reports in the literature of toxic effects of bifonazole referable to overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antifungals for topical use, imidazole and triazole derivatives.
ATC code: D01AC10.
Azolmen is bifonazole, a broad spectrum antifungal.
Azolmen exerts a safe and effective action against infections sustained by dermatophytes, saccharomyces (yeasts), molds and other pathogenic fungi such as Malassezia furfur; it is also active against some Gram positive germs such as Corynebacterium minutissimum, Staphylococcus aureus and Streptococcus pyogenes.
05.2 "Pharmacokinetic properties
Tests carried out in humans have shown a negligible systemic absorption of the active principle for epicutaneous application, being the absorption itself equal to values that are around 0.6-0.8% of the quantity applied depending on the formulation used.
Studies carried out after single or repeated topical administration have shown plasma concentrations always lower than 1 ng / mL, i.e. always such that they cannot induce any systemic effect.
Azolmen, available only in forms for dermatological application, therefore has only a local therapeutic action.
05.3 Preclinical safety data
Acute and chronic toxicity tests carried out on animals treated systemically and / or topically, allow us to state that the tolerability of the preparation, even when it is applied for long periods, is very high.
In particular, subchronic toxicity studies carried out in dogs demonstrated the absence of toxic effects even at doses of 1 mg / kg / day administered for 13 weeks, orally.
The preparation, given orally in single doses of 1200 mg / kg, has also proved to be completely devoid of mutagenic and embryo-toxic effects.
In perinatal and postnatal toxicity tests, performed in rats, treatment with 10 and 20 mg / kg / day of the drug was tolerated by both pregnant females, fetuses, and offspring, without giving rise to any signs of toxicity. .
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cream
sorbitan monostearate; polysorbate 60; spermaceti; cetylstearyl alcohol; octyldodecanol; benzyl alcohol; purified water.
Gel
mixture of ethoxylated fatty alcohols; glycerides of ethoxylated fatty acids; isopropylisostearate; ethyl alcohol; lactic acid; benzyl alcohol; purified water.
Skin solution
ethanol; isopropyl myristate.
Skin powder
non-gellable rice starch.
06.2 Incompatibility
No incompatibility phenomena of bifonazole with other medicinal products have been reported in the literature.
06.3 Period of validity
Cream, solution and powder
5 years.
Gel
4 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Cream and gel
Aluminum tube internally protected with epoxy resins.
30 g tube.
Skin solution
Dark glass bottle.
30 mL bottle.
Dust
Polyethylene bottle.
Bottle of 30 g.
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
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence.
08.0 MARKETING AUTHORIZATION NUMBER
Cream - 026048090
Gel - 026048102
Skin solution - 026048114
Skin powder - 026048126
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Cream, gel, skin solution, skin powder
Date of first authorization: October 1985
Date of most recent renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
March 2015
