АТСОЛМЕН 1% Крем

Содержание инструкции

1. AZOLMEN 1% cream, 1% gel, 1% cutaneous solution, 1% cutaneous powder
   1. What AZOLMEN is and what it is used for
   2. What you need to know before using AZOLMEN
   3. How to use AZOLMEN
   4. Possible side effects
   5. How to store AZOLMEN
   6. Package Contents and Other Information
2. AZOLMEN 1% cutaneous foam

AZOLMEN 1% cream, 1% gel, 1% cutaneous solution, 1% cutaneous powder

Bifonazole
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4. See a doctor if you do not improve or if your symptoms worsen after 2 - 4 weeks.

Contents of this leaflet:

• 1. What AZOLMEN is and what it is used for
• 2. What you need to know before using AZOLMEN
• 3. How to use AZOLMEN
• 4. Possible side effects
• 5. How to store AZOLMEN
• 6. Contents of the pack and other information

1. What AZOLMEN is and what it is used for

AZOLMEN contains bifonazole and is a broad-spectrum antimycotic (antifungal) that acts against
infections caused by dermatophytes (skin-parasitic fungi), saccharomycetes (yeasts), molds and other
pathogenic fungi such as, for example, Malassezia furfur.

Azolmen 1% cream, Azolmen 1% gel, Azolmen 1% cutaneous solutionare used in the treatment of
dermatomycoses (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) with superinfections caused by the aforementioned pathogenic fungi and bacteria
sensitive to AZOLMEN.
Within the scope of these diseases are included: 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 (of the skin), pityriasis versicolor.

Azolmen 1% cutaneous powderis indicated for the therapy of moist skin and skin fold mycoses
especially if located 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.
Consult your doctor if you do not feel better or if you feel worse after 2 - 4 weeks.

2. What you need to know before using AZOLMEN

Do not use AZOLMEN
If you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Azolmen.
Do not use the medicine for a period of time longer than that indicated in section 3 “How to use
Azolmen”.
The use, especially prolonged, of medicines for topical (local) use, may give rise to sensitization
phenomena (a complex of phenomena that occur in the body due to the action of certain
substances and that lead to a particular reactivity towards them). In this case it is necessary
to interrupt the treatment and the doctor will prescribe you a suitable therapy. You should behave
similarly in case of development of resistant microorganisms (i.e. those that no longer respond to the
medicine).

Children
The medicine should only be used in case of actual need and under the direct control of the doctor.

Other medicines and AZOLMEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions of bifonazole with other drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use this medicine only in case of actual need and under the direct control of the doctor.

Driving and operating machinery
AZOLMEN does not impair the ability to drive vehicles and operate machinery.

AZOLMEN cream contains cetylstearyl alcoholwhich may cause local skin reactions (e.g. contact
dermatitis).

3. How to use AZOLMEN

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For 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 stop therapy immediately after the disappearance of acute inflammatory manifestations (inflammation) and symptoms, but you must adhere to the following average treatment times, depending on the type of
infection, its extent and location:

• Tinea pedis (athlete's foot) 3 weeks
• Tinea corporis, tinea manuum, tinea cruris (cutaneous fungal infections affecting respectively the body, the hand and the groin) 2-(3) weeks
• Pityriasis versicolor (fungal infection manifesting with 2 weeks coffee-colored spots, usually located on the trunk)
• Superficial cutaneous candidiasis (fungal infection of the skin) 2-(4) weeks

The treatment times indicated in parentheses refer to types of infection, at the doctor's discretion,
particularly extensive or resistant.

Azolmen 1% cream and Azolmen 1% gel
Are particularly indicated for the treatment of exposed skin areas.
Unless otherwise prescribed by your doctor, apply once a day, preferably in the evening before
going to bed, a small amount of product (e.g. 1 or 2 cm) to cover an area the size of
your palm, gently massaging the affected areas.
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
the current infection is associated with an inflammatory component with a sensation of burning and/or
skin itching.

Azolmen 1% cutaneous solution
Is especially useful for the treatment of skin areas covered with hair as well as fungal infections in
skin folds, with the exception of mucous membranes.
Unless otherwise prescribed by your doctor, apply once a day, preferably in the evening before
going to bed, a small amount of product sufficient to cover an area the size of your palm,
gently massaging the affected areas.
This product is odorless, does not stain and can be easily removed with water.

Azolmen 1% cutaneous powder
Sprinkle the affected skin areas with the powder one or more times a day depending on the degree of humidity
and the location of the fungal infections.
At the doctor's opinion, the product can be applied as an addition to the treatment with Azolmen 1%
cream, Azolmen 1% gel or Azolmen 1% cutaneous solution (e.g. in the morning cutaneous powder, in the evening
cream, gel or cutaneous solution).
In case of tinea pedis, you can sprinkle Azolmen 1% cutaneous powder in shoes and socks also in order to
eliminate humid conditions and prevent the infection from returning.

If you use more AZOLMEN than you should
No toxic effects of the drug attributable to taking an excessive dose have been reported.
AZOLMEN acts only at the local level; the absorption of the product at the systemic level (throughout
the body) is negligible.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
AZOLMEN is generally well tolerated.
Only in rare cases may a mild and mostly transient redness of the skin occur, and more
rarely a burning and irritation sensation, which usually disappear quickly.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store AZOLMEN

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 packaging. The expiry date refers to the last day of that month and the product in intact packaging, correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What AZOLMEN contains
AZOLMEN 1% cream
100 g of cream contains:

Active ingredient: bifonazole 1 g.

Other ingredients: sorbitan monostearate, polysorbate 60, spermaceti, cetylstearyl alcohol, octyldodecanol,
benzyl alcohol, purified water.
AZOLMEN 1% gel
100 g of gel contains:

Active ingredient: bifonazole 1 g.

Other ingredients: mixture of ethoxylated fatty alcohols, ethoxylated fatty acid glycerides, isopropyl myristate,
ethanol, lactic acid, benzyl alcohol, purified water.
AZOLMEN 1% cutaneous solution
100 ml of solution contains:

Active ingredient: bifonazole 1 g.

Other ingredients:ethanol, isopropyl myristate.
AZOLMEN 1% cutaneous powder
100 g of powder contains:

Active ingredient: bifonazole 1 g.

Other ingredients:non-gelatinizing rice starch.

Description of the appearance of AZOLMEN and package contents
1% Cream: tube containing 30 g, shiny white cream.
1% Gel: tube containing 30 g, transparent gel.
1% Cutaneous solution: 30 ml bottle, clear colorless or pale yellow solution.
1% Cutaneous powder: 30 g bottle, odorless white powder.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence.

Manufacturer
AZOLMEN 1% Cream, AZOLMEN 1% gel, AZOLMEN 1% cutaneous solution
A.Menarini Manufacturing Logistics and Services s.r.l., production site in Via Sette Santi, 3 - Florence.

AZOLMEN 1% Cutaneous powder
Bayer HealthCare Manufacturing s.r.l., via delle Groane 126, Garbagnate Milanese (Milan).

• A. Menarini Manufacturing Logistics and Services s.r.l., production site in Via Sette Santi, 3 - Florence.

AZOLMEN 1% cutaneous foam

bifonazole
PHARMACOTHERAPEUTIC ACTIVITY
Azolmen is bifonazole, a broad-spectrum antifungal with a safe and effective action against infections caused by dermatophytes, saccharomycetes (yeasts), molds and other pathogenic fungi such as
e.g. Malassezia furfur; it is also active against some Gram-positive germs such as Corynebacterium
minutissimum, Staphylococcus aureus and Streptococcus pyogenes.

THERAPEUTIC INDICATIONS
Azolmen cutaneous foam is indicated for the treatment of pityriasis versicolor, which in its typical form
manifests with macules covered by scales.
Treatment of the entire body surface makes it possible to eliminate the pathogenic agent not only
where morphological skin changes are detectable, but also where the skin is still apparently
healthy.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients of this medicine (listed in
paragraph 6).

PRECAUTIONS FOR USE
The use, especially prolonged, of topical medicines can give rise to sensitization phenomena;
in such case it is necessary to interrupt the treatment and institute appropriate therapy. Similarly, act
accordingly in case of development of resistant microorganisms.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, even those
without a prescription.
No interactions of bifonazole with other medicines or other forms of interaction have been reported in the literature.

SPECIAL WARNINGS
Do not use for prolonged treatments. After a short period of treatment without appreciable results
consult your doctor.
Pregnancy and breastfeeding
In pregnant women, the medicine should be used only in case of actual need and under
direct medical control.

Children
In early infancy, the medicine should be used only in case of actual need and under direct
medical control.
Important information on some excipients:
AZOLMEN contains cetylstearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Apply the contents of one sachet, for three consecutive evenings, to the entire wet body after a shower,
placing the product on a sponge; then rub for 3-5 minutes, do not rinse. The medicine
exerts its action during the night and should be removed by washing the next morning.
If after 15 days from the end of therapy the pityriasis versicolor has not been eradicated, repeat the
treatment. To avoid relapses, it is recommended to repeat the treatment again after 1 and 3 months.

OVERDOSE
No toxic effects of bifonazole attributable to
overdose have been reported in the literature.
In cases of accidental ingestion/intake of an excessive dose of Azolmen, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts about the use of Azolmen, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Azolmen can cause side effects, although not everyone will
experience them.
Azolmen is perfectly tolerated.
Only in rare cases may a slight and mostly transient redness of the skin occur and more
rarely a sensation of burning and irritation, which normally disappear quickly.
Azolmen exerts a therapeutic activity only at the local level, so systemic repercussions can be ruled out.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili By reporting side effects you can contribute to providing more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date. See the expiry date indicated on the packaging.
Caution: Do not use the medicine after the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.

COMPOSITION
100 g of foam contain:
Active ingredient: bifonazole 1 g.
Excipients: polyoxyethylene-7-glyceryl ester with fatty acids (C8-C18) 20 g; polyoxyethylene glycol-cetylstearyl alcohol 20 g; cocamidopropyl betaine 10 g; isopropyl myristate 5 g; ethyl alcohol 5 g; benzyl alcohol 1 g; lactic acid 1 g; lilac perfume 0.25 g; purified water 36.75 g.

PHARMACEUTICAL FORM AND CONTENT
Cutaneous foam.
PVC/aluminum sachet
Pack of 6 sachets of 10 g

MARKETING AUTHORISATION HOLDER

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence.

MANUFACTURER
LAMP San Prospero – Via della Pace, 25/a – San Prospero – Modena.