Active ingredients: Ciclopirox olamine
MICLAST 1% cream
MICLAST 1% skin emulsion
MICLAST 1% cutaneous powder
MICLAST 1% cutaneous solution
Indications Why is Miclast used? What is it for?
MICLAST contains the active ingredient ciclopirox olamine.
MICLAST belongs to a group of medicines called "antifungals".
MICLAST is used for certain fungal infections of the skin (cutaneous mycosis caused by sensitive fungi).
Contraindications When Miclast should not be used
Do not use MICLAST
- if you are allergic to ciclopirox olamine or any of the other ingredients of this medicine;
- on wounds in the case of MICLAST cutaneous powder.
Precautions for use What you need to know before taking Miclast
Talk to your doctor or pharmacist before using MICLAST.
Avoid contact with eyes.
Use MICLAST with caution and under direct medical supervision:
- in case of simultaneous treatment with other antifungals administered by routes other than the cutaneous route (systemic antifungal treatment);
- if you have been diagnosed with severe defects in your immune defenses (immunosuppression) in the past;
- if your immune system is compromised, such as in the case of a transplant and infection with the AIDS virus (HIV);
- if you are diabetic.
The use, especially if prolonged, of products for local use can cause allergic reactions (sensitization). In this case, stop the treatment and contact your doctor.
During treatment, carefully observe the hygiene measures recommended by your doctor and / or pharmacist. If you have a Candida infection, do not use an acid soap, because it can promote its proliferation.
Cream:
Avoid contact with mucous membranes.
Do not apply on wounds.
Interactions Which drugs or foods can modify the effect of Miclast
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known interactions with other medicines.
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.
Cream, skin emulsion, skin solution
Pregnancy
As a precautionary measure, it is preferable to avoid the use of MICLAST 1% cream, skin emulsion, skin solution during pregnancy, as there are insufficient data on the use of ciclopirox olamine in pregnant women.
Feeding time
MICLAST 1% cream, cutaneous emulsion, cutaneous solution should not be used during breastfeeding, as there is insufficient information on the excretion of ciclopirox olamine and its potential metabolites in breast milk. Therefore, a risk to newborns and infants cannot be excluded.
Skin powder
MICLAST cutaneous powder can be used during pregnancy or breastfeeding.
Driving and using machines
MICLAST does not affect the ability to drive and use machines.
MICLAST cream contains stearyl alcohol and cetyl alcohol
MICLAST cream contains stearyl alcohol and cetyl alcohol, which can cause local skin reactions (eg contact dermatitis).
MICLAST skin emulsion contains benzoic acid and butylated hydroxyanisole
MICLAST skin emulsion contains benzoic acid and butylhydroxyanisole which can cause local skin reactions (eg contact dermatitis) or be mildly irritating to the skin, eyes and mucous membranes.
Dose, Method and Time of Administration How to use Miclast: 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.
The different preparations make it possible to adopt, in the opinion of the doctor and / or pharmacist, the one most suitable for the individual case.
Unless otherwise directed by your doctor, the recommended dose is:
Cream:
Apply 2 or 3 times a day on skin lesions and let the preparation dry.
Repeat the treatment until the skin lesions disappear which usually occurs in 2 weeks; to avoid recurrence, continue with the treatment for 1-2 weeks after the lesions have disappeared.
The cream is particularly suitable for hairless areas of limited size.
Skin emulsion:
Shake the bottle well before use. Apply 2 or 3 times a day to skin lesions and let the preparation dry.
Repeat the treatment until the skin lesions disappear which usually occurs in 2 weeks; to avoid recurrence, continue with the treatment for 1-2 weeks after the lesions have disappeared.
The skin emulsion is indicated for large skin areas and areas with hair growth (hairy areas).
Skin powder:
Spread on the affected areas 1-2 times a day and repeat the treatment until the skin lesions disappear; to avoid recurrence, continue with the treatment for 1-2 weeks after the lesions have disappeared. Use the powder for prophylactic purposes and for the disinfection of socks and shoes.
Skin solution:
Apply 2-3 times a day, rubbing lightly and repeat the treatment until the skin lesions disappear which generally occurs in 2 weeks; to avoid recurrence continue with the treatment for 1-2 weeks after the lesions have disappeared.
Overdose What to do if you have taken too much Miclast
There are no known effects of overdose.
Side Effects What are the side effects of Miclast
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of MICLAST the following undesirable effects may occur:
Cream, skin emulsion and skin solution
Common side effects (may affect up to 1 in 10 people)
Worsening of symptoms in the application area:
- burning sensation;
- redness;
- itch.
These side effects occur during the first few applications and are temporary. It is not necessary to stop the treatment.
Uncommon side effects (may affect up to 1 in 100 people)
- general allergic reactions (hypersensitivity);
- vesicles in the application area. Stop the treatment and consult your doctor as soon as possible if any of these side effects occur.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- local skin inflammations, such as eczema and contact dermatitis.
There are no known undesirable effects that can affect the whole organism. This possibility, however, cannot be excluded in patients undergoing prolonged treatment on large surfaces, on wounds, on mucous membranes or in the case of use of dressings that do not allow the dispersion of the drug ( occlusive dressing).
Skin powder
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- skin inflammations, such as eczema and contact dermatitis;
- local allergic reactions of the skin, such as tingling, irritation, redness, erythema, itching and / or numbness in the area of application.
Compliance with the instructions contained in this leaflet reduces the risk of undesirable effects.
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 via the national reporting system at www.agenziafarmaco.it/it/responsabili. 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.
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.
Do not throw away 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.
Cream:
Do not store above 30 ° C.
Skin emulsion:
No particular storage conditions are required.
Skin powder:
Do not store above 30 ° C.
Skin solution:
No particular storage conditions are required. Do not use the medicine after 21 days of first opening.
Other information
What MICLAST contains
MICLAST 1% 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, sorbitan stearate, benzyl alcohol, lactic acid, purified water.
MICLAST 1% skin emulsion
- The active ingredient is ciclopirox olamine. 1 g of skin emulsion contains 10 mg of ciclopirox olamine.
- The other ingredients are: polyoxyethylene glycol palmito-stearate, polyoxyethylene glycerides of saturated fatty acids, liquid paraffin, benzoic acid, butylhydroxyanisole, purified water.
MICLAST 1% 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, pregelatinised maize starch.
MICLAST 1% 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.
What MICLAST looks like and contents of the pack
MICLAST is available in the following pharmaceutical forms:
- Cream: 30 g tube of 1% cream.
Homogeneous, odorless, whitish cream
- Skin emulsion: 30 g bottle of 1% skin emulsion.
Homogeneous emulsion, white to yellowish white.
- Skin powder: 30g bottle of 1% skin powder.
Fine, homogeneous, practically white, fluid and lump-free powder
- Cutaneous solution: bottle of 30 ml of 1% cutaneous solution.
Clear, colorless or slightly yellow liquid.
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
MICLAST
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cream:
One gram of cream contains 10 mg of cyclopyroxolamine.
Excipients with known effects:
one gram of cream contains 0.0575 g of cetyl alcohol, 0.0575 g of stearyl alcohol.
Skin emulsion: one gram of skin emulsion contains 10 mg of cyclopyroxolamine.
Excipients with known effects:
one gram of skin emulsion contains 3 mg of benzoic acid (E210), 0.06 mg of butylated hydroxyanisole (E320).
Skin powder: One gram of skin powder contains 10 mg of cyclopyroxolamine.
Skin solution:
One ml of cutaneous solution contains 10 mg of cyclopyroxolamine.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Homogeneous, odorless, whitish cream.
Skin emulsion
Homogeneous emulsion, white to yellowish white.
Skin powder
Fine, homogeneous, practically white, fluid and lump-free powder.
Skin solution
Clear, colorless or slightly yellow liquid.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Skin mycoses sustained by sensitive fungi
04.2 Posology and method of administration
The different preparations make it possible to adopt, in the opinion of the doctor, the one most suitable for the individual case. Unless otherwise prescribed, the dosage is usually as follows:
Cream: apply 2 or 3 times a day on skin lesions and let the preparation dry. Repeat the treatment until the skin lesions disappear (usually 2 weeks); to avoid relapses it is recommended to continue for 1-2 weeks. The cream is particularly suitable for hairless and limited areas.
Skin emulsion: shake the bottle well before use. Apply 2 or 3 times a day on the skin lesions and let the preparation dry. Repeat the treatment until the skin lesions disappear (usually 2 weeks); to avoid recurrence it is recommended to continue for 1-2 weeks. The emulsion is indicated for extended skin areas and for mycosis of hairy areas.
Skin powder: sprinkle the affected areas 1-2 times a day and repeat the treatment until the skin lesions disappear; to avoid relapses it is recommended to continue for 1-2 weeks. The use of the powder for prophylactic purposes and for the disinfection of socks and shoes is recommended.
Skin solution: apply 2-3 times a day, rubbing lightly and repeat the treatment until the skin lesions disappear (usually 2 weeks); to avoid relapses it is recommended to continue for 1-2 weeks.
04.3 Contraindications
Hypersensitivity to ciclopiroxolamine or to any of the excipients listed in section 6.1. The powder should not be applied to open wounds.
04.4 Special warnings and appropriate precautions for use
Cream, skin emulsion, skin solution and skin powder
Avoid contact with eyes Cyclopyroxolamine should be used with caution and under direct medical supervision:
- in case of concomitant systemic antifungal treatment;
- in subjects with a history of immunosuppression;
- in patients with compromised immune systems, such as transplant recipients and those with HIV infection;
- in diabetic subjects.
The use, especially if prolonged, of products for topical use, can cause sensitization phenomena. In this case it is necessary to interrupt the treatment and adopt suitable therapeutic measures.
In the course of treatment, the hygiene measures recommended by the doctor must be strictly observed.
In case of candidiasis, the use of an acidic soap is not recommended (the acid pH favors the proliferation of Candida).
Cream
Avoid contact of Miclast 1% cream with mucous membranes. Do not apply Miclast 1% cream on open wounds.
Important information about some of the excipients:
Cream:
Miclast 1% cream contains stearyl alcohol and cetyl alcohol which can cause local skin reactions (eg contact dermatitis).
Skin emulsion:
Miclast 1% skin emulsion contains benzoic acid (E210) and butylhydroxyanisole (E320) which can cause local skin reactions (eg contact dermatitis) or mild irritation of the skin, eyes and mucous membranes.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
04.6 Pregnancy and breastfeeding
Cream, skin emulsion and skin solution
Pregnancy
There are no or limited data (less than 300 pregnancy data) from the use of ciclopiroxolamine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity following oral, topical or subcutaneous administration of cyclopyroxolamine (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Miclast 1% cream, skin emulsion and skin solution during pregnancy.
Feeding time
There is insufficient information on the excretion of cyclopyroxolamine and its potential metabolites into breast milk. A risk to the newborns / infants cannot be excluded. Miclast 1% cream, skin emulsion and skin solution should not be used during breastfeeding. ..
Skin powder
Pregnancy
No effects are expected during pregnancy, since systemic exposure to cyclopyroxolamine following application is negligible. Miclast 1% cutaneous powder can be used during pregnancy.
Feeding time
No effects on breast-fed infants are anticipated, since systemic exposure to cyclopyroxolamine in nursing women is negligible. Miclast 1% cutaneous powder can be used during lactation.
Fertility
In experimental studies in rats, no effects on male and female fertility were shown after oral administration of cyclopyroxolamine in doses up to 5 mg / kg / day.
04.7 Effects on ability to drive and use machines
Miclast does not affect the ability to drive or use machines.
04.8 Undesirable effects
Cream, skin solution and skin emulsion
Summary of the safety profile
- Hypersensitivity and application site blisters require discontinuation of treatment.
- Exacerbation of local symptoms at the application site does not require discontinuation of treatment.
Summary table of adverse reactions
The table below presents the adverse reactions according to the Classification
MedDRA for Systems and Organs.
Frequencies have been defined according to the following convention: very common (≥ 1/10); common (≥ 1/100,
* They have been reported during marketing.
Although no systemic effect has been reported, this should be considered in patients undergoing prolonged treatment over large surfaces, broken skin, mucosa or under occlusive dressing.
Skin powder
Summary table of adverse reactions
The table below presents adverse reactions according to the MedDRA System Organ Class.
Frequencies have been defined using the following convention: Very common (≥ 1/10); common (≥ 1/100,
All of these undesirable effects have been reported during marketing.
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 www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
There are no known overdose syndromes.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antifungals for cutaneous use.
ATC code D01AE14.
MICLAST is a drug with local antifungal action.
The active ingredient is ciclopirox olamine, a molecule characterized by a broad spectrum and marked inhibitory activity on dermatophytes (such as Microsporum, Epidermophyton, Trichophyton), yeasts (Candida albicans), molds and other fungi (such as Malassezia furfur); it is also active on Gram-positive bacteria (streptococci and staphylococci).
Most of the tested fungal strains are inhibited by ciclopirox olamine at very low concentrations ranging from 1 to 4 mcg / ml.
The activity of the drug is attributed to intracellular depletion of some substrates and essential ions, determined by the inhibition of their absorption by the medium.
05.2 Pharmacokinetic properties
In penetration tests, ciclopirox olamine demonstrates marked penetration activity through the epidermis and thick layers of horny tissue of the skin and nails.
"In vivo" its absorption varies according to the method of application.
In fact, via the dermal route it is about 1% of the quantity used, while for oral administration it is about 75% of the ingested dose, according to determinations carried out on the rat and the dog. The half-life is approximately 12-14 h.
Pharmacokinetic tests, with 14C-ciclopirox olamine, have specified that, after topical application of the preparation at a concentration of 1%, the radioactivity in the blood begins to rise after about 1 hour to reach its maximum around the 6th hour after application. ; no sign of radioactivity appears recordable after 21 days.
No apparent influence on hemopressor levels, respiratory activity (in rabbits and cats), baseline electrocardiographic parameters (in cats) and reactivity of isolated organs was recorded for use of ciclopirox olamine in single doses.
05.3 Preclinical safety data
Acute toxicity studies with ciclopiroxolamine in rats and mice following oral or subcutaneous administration demonstrate similar and low toxicity (LD 50 between 1740 mg / kg and 2500 mg / kg).
Repeat dose toxicity studies with ciclopiroxolamine demonstrated good systemic tolerability with chronic oral dose with no observable adverse effect of 10 mg / kg / day in rats and dogs.
A full set of genotoxicity studies did not demonstrate any genotoxic potential for cyclopyroxolamine. A "dubious" clastogenic activity was shown in the HPRT / V79 test, as evidenced by the significant increase in mutation preferentially affecting small colonies in the mouse lymphoma test. Cyclopyroxolamine also significantly inhibited DNA repair activity in the UDS assay but with no genotoxic effect in this assay. However, the hypothesis was that the in vitro clastogenic activity of cyclopyroxolamine was directly related to its chelating potential against the calcium present. in the culture medium.
Carcinogenicity studies with cyclopyroxolamine have not been conducted.
Oral ciclopirox olamine has no adverse effects on male or female fertility in rats at a dosage up to 5 mg / kg / day.
No embryotoxic or teratogenic effects were observed after oral, topical or subcutaneous administration of ciclopirox olamine. The studies were conducted in several animal species, including mice, rats, rabbits and monkeys.
Oral cyclopyroxolamine has no perinatal or postnatal adverse effects when administered to female rats in doses up to 5 mg / kg / day from gestation day 15 until weaning.
Cream
Local tolerance studies in rabbits have shown that the cream (1%) causes slight skin and eye irritation. Miclast 1% cream was considered as a sensitizer in the guinea pig (0.1 ml per single application), however the photosensitizing potential has not been evaluated and therefore cannot be excluded. No photoirritation was observed. In the LLNA test in mice, the cream (1%) was not sensitizing.
Skin powder
When applied to healthy or scarred rabbit skin, either once within 24 hours or daily for 28 days, the skin powder (1%) is non-irritating.
When tested in guinea pigs according to the Magnusson and Kligman method, the skin powder (1%) was classified as low sensitizing.
Skin solution
When applied once within 24 hours, on healthy and scarified skin of the rabbit, the cutaneous solution (1%) is not irritating. At this concentration in dogs a slight transient erythema with formation of small blisters has been observed, following of daily application for 6 months on healthy and scarified skin.
When applied once to the conjunctival mucosa of the rabbit eye, the cutaneous solution (1%) induced a slight temporary irritation.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cream: octyldodecanol, light liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, polysorbate 60, sorbitan stearate, benzyl alcohol, lactic acid, purified water.
Skin emulsion: polyoxyethylene glycol palmito-stearate, polyoxyethylene glycerides of saturated fatty acids, liquid paraffin, benzoic acid, butylhydroxyanisole, purified water.
Skin powder: anhydrous colloidal silica, pregelatinised maize starch.
Skin solution: macrogol 400, isopropyl alcohol, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
MICLAST 1% cream: 2 years when properly stored intact packaging.
MICLAST 1% skin emulsion: 3 years in intact packaging, properly stored.
MICLAST 1% skin powder: 3 years in intact packaging, properly stored.
MICLAST 1% cutaneous solution: 42 months when the packaging is intact, properly stored. After the first opening of the bottle, the product is valid for 21 days without any storage conditions.
06.4 Special precautions for storage
MICLAST 1% cutaneous powder: store at a temperature not exceeding 30 ° C.
MICLAST 1% cream: store at a temperature not exceeding 30 ° C.
MICLAST 1% cutaneous solution: no particular storage conditions.
MICLAST 1% skin emulsion: no particular storage conditions
06.5 Nature of the immediate packaging and contents of the package
MICLAST 1% cream: 30 g tube, in flexible aluminum, protected with a layer of resin, equipped with a white resin conical screw capsule.
MICLAST 1% skin emulsion: 30 g HDPE bottle equipped with PE dropper and cap with safety closure.
MICLAST 1% skin powder: 30 g HDPE bottle fitted with LDPE sprinkler, with HDPE screw cap.
MICLAST 1% cutaneous solution: 30 ml bottle in LDPE with TRISEAL closure in LDPE, supplied with a spray to facilitate the application of the product (with immersion tube in PP).
06.6 Instructions for use and handling
MICLAST 1% skin emulsion: shake well before use.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Pierre Fabre Italia S.p.A.
Via Winckelmann, 1 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
MICLAST 1% cream: 025218013
MICLAST 1% skin emulsion: 025218090
MICLAST 1% cutaneous powder: 025218114
MICLAST 1% cutaneous solution: 025218102
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
MICLAST 1% cream: May 1984 / June 2010
MICLAST 1% skin emulsion: May 1984 / June 2010
MICLAST 1% cutaneous powder: December 2006 / June 2010
MICLAST 1% cutaneous solution: December 2006 / June 2010
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