МИКЛАСТ <10 мг/г Крем

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1. MICLAST 10 mg/g cream, 10 mg/g cutaneous powder, 10 mg/ml cutaneous solution
   1. What is MICLAST and what is it used for
   2. What you need to know before you use MICLAST
   3. How to use MICLAST
   4. Possible side effects
   5. How to store MICLAST
   6. Package Contents and Other Information

MICLAST 10 mg/g cream, 10 mg/g cutaneous powder, 10 mg/ml cutaneous solution

Ciclopirox olamine

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 to do.

• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is MICLAST and what is it used for

MICLAST contains the active ingredient ciclopirox olamine.
MICLAST belongs to a group of medicines called “antifungals”.
MICLAST is used for some fungal skin infections (skin mycoses caused by fungi sensitive
to the drug).

2. What you need to know before you use MICLAST

Do not use MICLAST

• if you are allergic to the active ingredient (ciclopirox olamine) or to any of the other ingredients of this medicine (listed in section 6);
• on wounds in the case of MICLAST cutaneous powder.

Warnings and precautions
Talk to your doctor or pharmacist before using MICLAST.
Avoid contact with the eyes.
Use MICLAST with caution and under the direct supervision of your doctor:

• in case of simultaneous treatment with other antifungals administered by routes other than the cutaneous route (systemic antifungal treatment);
• if you have previously been diagnosed with severe immune deficiencies (immunosuppression);
• if your immune system is compromised, as in the case of transplantation and HIV (AIDS) infection;
• if you are diabetic.

In case of any allergic reaction, stop treatment immediately, carefully remove the
product and consult your doctor.
During treatment, carefully observe the hygiene measures recommended by your doctor
and/or pharmacist.
If you have a Candida infection (a fungal infection), do not use an acidic soap,
because it may promote its proliferation.

Cream:
Avoid contact with mucous membranes.
Do not apply to wounds.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Cream and cutaneous solution

Pregnancy
As a precautionary measure, it is preferable to avoid the use of MICLAST 10 mg/g cream and MICLAST
10mg/ml cutaneous solution during pregnancy, as there is insufficient data on the use
of ciclopirox olamine in pregnant women.

Breastfeeding
MICLAST 10 mg/g cream and MICLAST 10mg/ml cutaneous solution should not be used
during breastfeeding, as there is insufficient information
on the excretion of ciclopirox olamine and its potential metabolites into breast milk. Therefore
a risk to newborns and infants cannot be excluded.

Cutaneous powder
MICLAST cutaneous powder can be used during pregnancy or breastfeeding.

Driving and using machines
MICLAST does not impair the ability to drive and operate machines.

MICLAST cream contains stearyl alcohol, cetyl alcohol, benzyl alcohol and polysorbate 60.
MICLAST cream contains:

• stearyl alcohol and cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
• 10 mg of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions and mild local irritation.
• polysorbates which may cause allergic reactions.

3. How to use MICLAST

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The different formulations allow, at the doctor and/or pharmacist’s discretion,
the selection of the most suitable one for each individual case.
Unless otherwise indicated by your doctor, the recommended dose is:

Cream:
Apply 2 or 3 times a day to the skin lesions and allow the preparation to dry.
Repeat the treatment until the skin lesions disappear, which generally occurs within 2
weeks; to prevent recurrence, continue treatment for 1-2 weeks after the lesions have disappeared.
The cream is particularly suitable for hairless and limited areas.

Cutaneous powder:
Sprinkle on the affected areas 1-2 times a day and repeat the treatment until the skin lesions disappear; to prevent recurrence, continue treatment for 1-2 weeks after the
disappearance of the lesions. Use the powder for prophylactic purposes and for the disinfection of socks
and shoes.

Cutaneous solution:
Apply 2-3 times a day, rubbing gently and repeat the treatment until the skin lesions disappear, which generally occurs within 2 weeks; to prevent recurrence, continue
treatment for 1-2 weeks after the lesions have disappeared.

If you use more MICLAST than you should
No effects of overdose are known.

If you forget to use MICLAST
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of MICLAST, the following side effects may occur:

Cream and cutaneous solution

Common side effects (may affect up to 1 in 10 people)

• Temporary worsening of symptoms in the application area
• redness (erythema); or itching in the application area, these are mainly short-lived phenomena and treatment should not be interrupted;
• burning sensation of the skin;

Uncommon side effects (may affect up to 1 in 100 people)

• Generalized allergic reactions (hypersensitivity) which may be severe and whose symptoms include swelling (edema), itching, skin rash, itchy rash (urticaria), difficulty breathing (dyspnea).
• Blisters in the application area.

If any of these side effects occur, you must stop treatment immediately
and consult your doctor as soon as possible.

Side effects with unknown frequency (frequency cannot be estimated on the
basis of available data)

• local skin inflammations, such as eczema and contact dermatitis.

If you are undergoing prolonged treatment on large areas, on wounds, on mucous membranes or in the case of
use of bandages that do not allow the dispersion of the medicine (occlusive dressing), the
risks related to the passage of the drug into the bloodstream should be considered:
ask your doctor for advice.

Cutaneous powder

Side effects with unknown frequency (frequency cannot be estimated on the
basis of available data)

• Inflammation of the skin, such as eczema and contact dermatitis; At the application site, the following may occur: local skin allergic reactions (hypersensitivity), redness (erythema), itching, irritation, and/or numbness (hypoesthesia).

undesirable.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system 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.

5. How to store MICLAST

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

Cream:
Do not store at a temperature above 30°C.
Do not use the medicine after 3 months from first opening.

Cutaneous powder:
Do not store at a temperature above 30°C.

Cutaneous solution:
No special storage conditions are required.
Do not use the medicine after 1 month from first opening.

6. Package Contents and Other Information

What MICLAST contains
MICLAST10 mg/g cream

• The active ingredient is ciclopirox olamine. 1 g of cream contains 10 mg of ciclopirox olamine.
• The other ingredients are: octyldodecanol, light liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, polysorbate 60 (E435), sorbitan stearate, benzyl alcohol(E1519), lactic acid (E270), purified water.

MICLAST10 mg/g cutaneous powder

• The active ingredient is ciclopirox olamine. 1 g of cutaneous powder contains 10 mg of ciclopirox olamine.
• The other ingredients are: anhydrous colloidal silica, pregelatinized corn starch.

MICLAST10 mg/ml cutaneous solution

• The active ingredient is ciclopirox olamine. 1 ml of cutaneous solution contains 10 mg of ciclopirox olamine.
• The other ingredients are: macrogol 400, isopropyl alcohol, purified water.

Description of the appearance of MICLAST and package contents
MICLAST is available in the following pharmaceutical forms:

Cream:tube containing 30 g of cream.
Homogeneous, odorless cream, whitish in color.

Cutaneous powder:30 g (High-density polyethylene) bottle of powder
for topical use with a screw cap (High-density polyethylene).
Fine, homogeneous, practically white, fluid and lump-free powder.

Cutaneous solution: 30 ml (Low-density polyethylene) bottle of solution
for topical use with a spray and closed with a cap.
Clear, colorless or slightly yellow liquid.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pierre Fabre Italia S.p.A.
Via G. Washington, 70
20146 Milan - Italy

Manufacturer

Cream:
Pierre Fabre Médicament Production – Rue du Lycee Z.I. de Cuiry – 45500 Gien - France

Cutaneous powder:
Laboratoires M. Richard – Rue du Progrès ZI des Reys de Saulce – 26270 Saulce Sur Rhone -
France

Cutaneous solution:
Pierre Fabre Médicament Production – Rue du Lycee Z.I. de Cuiry – 45500 Gien - France