AZOLMEN

Package leaflet: Information for the user

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

Bifonazole
Please read all of this leaflet carefully before you start using this medicine because 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 to do.
• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Consult your doctor if you do not notice improvement or if you notice worsening of symptoms 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 antifungal agent effective against infections caused by dermatophytes (parasitic fungi of the skin), saccharomycetes (yeasts), molds, and other pathogenic fungi such as Malassezia furfur.
Azolmen 1% cream, Azolmen 1% gel, Azolmen 1% cutaneous solution are used in the treatment of dermatomycoses (skin diseases caused by fungi) due to dermatophytes, saccharomycetes (e.g. Candida), and other pathogenic fungi (e.g. Malassezia furfur). They are also used in dermatoses (non-inflammatory skin diseases) complicated by superinfections caused by the aforementioned pathogenic fungi and by bacteria sensitive to AZOLMEN.
Included among these conditions are: plantar and interdigital mycoses of the hands and feet (athlete's foot); onychomycosis (fungal infection of the nails); trunk and cutaneous fold mycoses; pityriasis versicolor.
Azolmen 1% cutaneous powder is indicated for the treatment of moist fungal skin infections and skin folds, especially when located in areas usually covered or poorly ventilated (e.g. diaper dermatitis, interdigital mycosis), as well as an adjunct 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 substance or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Azolmen.
Do not use this medicine for a longer period than that indicated in section 3 “How to use Azolmen”.
The use, especially prolonged, of topical (local) medicines may lead to sensitization phenomena (a complex of reactions occurring in the body in response to certain substances, leading to increased sensitivity to those substances). If this occurs, you must stop treatment and your doctor will prescribe appropriate therapy. Similarly, you should discontinue use if resistant microorganisms develop (i.e. microorganisms no longer responding to the medicine).

Children
This medicine should be used only when strictly necessary and under direct medical supervision.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine only when strictly necessary and under direct medical supervision.

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

AZOLMEN cream contains cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use AZOLMEN

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For complete recovery, it is essential that you strictly follow the instructions provided in this leaflet and use the medicine for the full duration required by the treatment of the infection.
Do not stop treatment immediately after the disappearance of acute inflammatory signs and symptoms; instead, adhere to the following average treatment durations depending on the type, extent, and location of the infection:

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

The treatment durations indicated in parentheses apply to types of infection that, in the physician's judgment, are particularly extensive or resistant.

Azolmen 1% cream and Azolmen 1% gel
Are particularly suitable for treating exposed skin areas.
Unless otherwise prescribed by your doctor, apply once daily, preferably in the evening before bedtime, a small amount of product (e.g., 1 or 2 cm) to cover an area approximately the size of the palm of your hand, gently massaging it into the affected areas.
These products are odorless, non-staining, and can be easily removed with water.
Azolmen 1% gel, thanks to the refreshing properties of its components, is particularly useful when the active infection is associated with an inflammatory component causing a burning sensation and/or skin itching.

Azolmen 1% cutaneous solution
Is especially useful for treating hairy skin areas and fungal infections located in skin folds, except mucous membranes.
Unless otherwise prescribed by your doctor, apply once daily, preferably in the evening before bedtime, a small amount of product sufficient to cover an area approximately the size of the palm of your hand, gently massaging it into the affected areas.
This product is odorless, non-staining, and can be easily removed with water.

Azolmen 1% cutaneous powder
Sprinkle the affected skin areas with the powder once or more times daily, depending on the degree of moisture and the location of the fungal infection.
On medical advice, the product may be used in addition to treatment with Azolmen 1% cream, Azolmen 1% gel, or Azolmen 1% cutaneous solution (for example: cutaneous powder in the morning, cream, gel, or cutaneous solution in the evening).
In cases of tinea pedis, Azolmen 1% cutaneous powder may also be sprinkled into shoes and socks to eliminate moist conditions and help prevent recurrence of the infection.

If you use more AZOLMEN than you should
No toxic effects related to overdose have been reported.
AZOLMEN acts only locally; systemic absorption (throughout the body) of the product is negligible.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
AZOLMEN is generally well tolerated.
Only in rare cases may mild, mostly transient skin redness occur, and even more rarely a sensation of burning and irritation, which usually disappear quickly.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 stated on the packaging. The expiry date refers to the last day of that month and to the product in its original packaging, stored correctly.
Do not dispose of any medicine via 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 contain:
Active substance: 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 substance: bifonazole 1 g.
Other components: mixture of ethoxylated fatty alcohols, ethoxylated fatty acid glycerides, isopropyl isostearate,
ethanol, lactic acid, benzyl alcohol, purified water.
Azolmen 1% cutaneous solution
100 ml of solution contain:
Active substance: bifonazole 1 g.
Other components: ethanol, isopropyl myristate.
Azolmen 1% cutaneous powder
100 g of powder contain:
Active substance: bifonazole 1 g.
Other components: non-gelatinizing rice starch.

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

Marketing Authorization 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 at 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 at Via Sette Santi, 3 -
Florence.

AZOLMEN 1% cutaneous foam
bifonazole

PHARMACOTHERAPEUTIC ACTIVITY
Azolmen contains bifonazole, a broad-spectrum antifungal agent with proven and effective activity against infections caused by dermatophytes, saccharomycetes (yeasts), molds, and other pathogenic fungi such as Malassezia furfur; it is also active against certain Gram-positive organisms including 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 presents as scaly macules.
Treating the entire body surface allows elimination of the pathogen not only from areas showing visible morphological skin changes, but also from areas where the skin appears apparently healthy.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients of this medicinal product (listed in section 6).

PRECAUTIONS FOR USE
Prolonged use of topical medicinal products may lead to sensitization reactions; in such cases treatment must be discontinued and appropriate therapy initiated. The same applies in case of emergence of resistant microorganisms.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.
No interactions between bifonazole and other medicinal products or other types of interactions have been reported in the literature.

SPECIAL WARNINGS
Do not use for prolonged treatments. If no appreciable improvement is observed after a short treatment period, consult your doctor.

Pregnancy and breastfeeding
In pregnant women, this medicinal product should be used only if clearly needed and under direct medical supervision.

Children
In very young infants, this medicinal product should be used only if clearly needed and under direct medical supervision.

Important information about certain excipients:
AZOLMEN contains cetylstearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply the contents of one sachet to the entire wet body for three consecutive evenings after a shower, using a sponge; then massage for 3–5 minutes without rinsing. The medicine acts overnight and should be washed off the following morning.
If pityriasis versicolor has not cleared within 15 days after completing treatment, repeat the course. To prevent relapse, repeat treatment after 1 and 3 months.

OVERDOSE
No reports of toxic effects of bifonazole related to overdose have been documented in the literature.
In case of accidental ingestion/overdose of Azolmen, contact your doctor immediately 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 everybody will experience them.
Azolmen is very well tolerated.
Only in rare cases may mild, mostly transient skin redness occur, and even more rarely a sensation of burning or irritation, which usually disappear quickly.
Azolmen exerts its therapeutic effect only at the local level, thus systemic effects can be excluded.

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

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
Warning: Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the product stored unopened and under proper storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.

COMPOSITION
100 g of foam contain:
Active substance: bifonazole 1 g.
Excipients: polyoxyethylene-7-glycerol esterified with fatty acids (C8-C18) 20 g; polyethylene glycol-30-cetylstearyl alcohol 20 g; cocamidopropyl betaine 10 g; isopropyl isostearate 5 g; ethanol 5 g; benzyl alcohol 1 g; lactic acid 1 g; lilac fragrance 0.25 g; purified water 36.75 g.

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

MARKETING AUTHORIZATION 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.