Lomexin cream for vaginal and external

RECORDATI Industria Chimica e Farmaceutica S.p.A.Summary of Product CharacteristicDermatological Fenticonazole – January năm ngoái

SAMMARY OF PRODUCTS CHARACTERISTICS

DERMATOLOGICAL FENTICONAZOLE

1.

TRADE NAME OF THE MEDICINAL PRODUCT

LOMEXIN 2% cream

LOMEXIN 2% gel

LOMEXIN 2% cutaneous solution,

LOMEXIN 2% cutaneous spray, solution

LOMEXIN 2% cutaneous powder

LOMEXIN 2% shampoo

LOMEXIN 2% cutaneous foam

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

2% cream:

100 g of cream contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )

2% gel:

100 g of gel contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )

2% cutaneous solution:

100 g of solution contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )

2% cutaneous spray, solution:

100 g of solution contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )

2% cutaneous powder:

100 g of powder contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )

2% shampoo:

100 g of solution contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )

2% cutaneous foam:

RECORDATI Industria Chimica e Farmaceutica S.p.A.Summary of Product CharacteristicDermatological Fenticonazole – January năm ngoái100 g of solution contain :

Active ingredient:

Fenticonazole nitrate 2 g ( equal to 1.757 g Fenticonazole )For a full list of excipients, see section 6.1 .

3.

PHARMACEUTICAL FORM

CreamCutaneous solutionCutaneous spray, solutionCutaneous powderShampooCutaneous foam

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Dermatomycoses from dermatophytes (Tricophyton, Microsporum, Epidermophyton) in different

locations : tinea capitis, tinea corporis, tinea cruris, tinea pedis ( athletes foot ), tinea manuum ,tinea faciei, tinea barbae, tinea unguium .Skin candidiasis ( intertrigo, perleche, facial candidiasis, “ diaper ” candidiasis, perineal and scrotalcandidiasis ) ; balanitis, balanoposthitis ; onychia and paronychia .

Pityriasis versicolor (from Pityrosporum orbiculare and P. ovale).

Otomycosis ( from Candida or yeasts ) ; only if there are no ear drum lesions .ErythrasmaMycosis with bacterial superinfections ( from Gram-positive bacteria ) .

Treatment of infections of the scalp from the yeast Pityrosporum such as seborrheal dermatitis

and Pityriasis capitis .

4.2

Posology and method of administration

Lomexin should be applied 1-2 times a day, as instructed by the physician, after having washed anddried the affected part, utilizing the appropriate formulation according to the location of the lesion .

2% cream and 2% gel – is indicated for the treatment of glabrous skin, of skin folds and mucosa; it

is applied byrubbing gently. Preferably, it is used for dry mycosis : Pityriasis versicolor, erythrasma ,onychomycosis ( in onychomycosis the cream should be applied with an occlusive bandage ) ; thecream is suitable for use in male genital mycosis .

2% cutaneous foam – the use of the foam is particularly indicated in the treatment of Pityriasis

Versicolor and in the case of extensive dermatomycosis of glabrous skin ; in these cases, the foamshould be applied in the evening on wet skin, either directly or utilizing a sponge, letting it dry andwashing it off the following morning. During the course of infections, LOMEXIN Skin foam maybe effectively used for cleansing, as it avoids further irritation of already affected skin, thanks to itsphysiological pH .

2% cutaneous spray, solution and 2% cutaneous solution – it is indicated for use on the scalp and

skin areas covered by hair. The spray solution is, moreover, easy and convenient to use for extensivemycosis and for areas which are difficult to reach .RECORDATI Industria Chimica e Farmaceutica S.p.A.Summary of Product CharacteristicDermatological Fenticonazole – January năm ngoái

2% cutaneous powder – it is used for athletes foot and, in general, for the intertrigous areas and for

humid lesions, both as single treatments and in addition to the cream .In foot infections, it is advised that the inside of socks and shoes should also be sprinkled withLomexin .In athletes foot and in onychomycosis, in order to avoid reinfections, it is appropriate to continue theabove indicated treatment for 1 or 2 weeks after the symptoms disappearance .

2% shampoo – Wash the affected areas with LOMEXIN Scalp Fluid; leave on for approximately 3-

4 minutes, then rinse thoroughly with water. Treatment: Twice a week for 2-4 weeks.

Lomexin is not greasy, does not stain and can be easily removed with water.

4.3

Contra-indications

Hypersensitivity to the active substance or to any of the excipients.

4.4

Special warnings and special precautions for use

When applied to the lesion, a slight burning sensation may be felt which disappears rapidly .Avoid contact with the eyes ; should this happen, rinse thoroughly with water .The use, especially if extended, of products for topical use, may give rise to sensitization .In such case, interrupt the treatment and consult a physician to commence an appropriate therapy .

4.5

Interactions with other medicaments and other forms of interaction

There are no known interactions with other medicines .

4.6

Fertility, Pregnancy and lactation

FertilityNo human studies of the effects of fenticonazole on fertility have been conducted, however animalstudies have not demonstrated any effects of the drug on fertility ( see Section 5.3 ) .PregnancyThere are limited amount of data from the use of fenticonazole in pregnant women. Studies inanimalshaveshownteratogeniceffects ,but embriotoxicfetotoxiceffectshavebeenobservedonlyveryhighdoses administeredorally( seeSection5.3 ) .Entirelynegligibleabsorption occurs by the transcutaneous route ( see Section 5.2 ). Fenticonazole should be used in

pregnancy under the supervision of a physician.

LactationAnimal studies via the oral route have shown that fenticonazole and / or its metabolites can beexcreted in the milk ( see Section 5.3 ). Even if no data are available showing that dermatologicaladministration of fenticonazole in humans causes its and / or its metabolites excretion into the milk ,a risk for the baby cannot be excluded. Fenticonazole should be used during lactation under thesupervision of a physician .

4.7

Effects on ability to drive and use machines

Lomexin has no influence on ability to drive and use machines .

4.8

Undesirable effects

RECORDATI Industria Chimica e Farmaceutica S.p.A.Summary of Product CharacteristicDermatological Fenticonazole – January năm ngoáiWhen used as recommended, Lomexin is only poorly absorbed and systemic undesirable reactionsare not expected. Prolonged use of topical products can cause sensitisation ( see section 4.4 ) .In the table below, adverse reactions are reported and listed by MedDRA system organ class andfrequency : very common ( ≥ 1/10 ) ; common ( ≥ 1/100 to < 1/10 ) ; uncommon ( ≥ 1/1, 000 to < 1/100 ) ;rare ( ≥ 1/10, 000 to < 1/1, 000 ) ; very rare ( < 1/10, 000 ), not known ( frequency cannot be estimated fromavailable data ) .

System Organ Class

Frequency

Preferred Terms

Skin and subcutaneous tissuedisordersvery rareErythemaPruritusRashRash ErythematousSkin irritationSkin burning sensation

4.9

Overdose

No risk of overdose has been identified in the post-marketing experience .

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapy groups : Antifungal for topical use, Imidazole derivatives. ATC code : D01AC12Lomexin is a broad spectrum antimycotic .

In

vitro:

highfungistaticfungicideactivitydermatophytes( allspecies of

Tricophyton, Microsporum, Epidermophyton), on Candida albicans and on other mycotic

infection agents of the skin and the mucosa ( dimorphous fungi – Pityrosporum – yeasts ) .

Moreover an inhibition of the secretion of the acid proteinase by Candida albicans, has been

shown in vitro .

In vivo: healing in 7 days of dermatophytes and Candida cutaneous mycosis in guinea pigs.

Lomexin also has an antibacterial action against Gram-positive microorganisms .Presumed action mechanism : blocking of oxidant enzymes with accumulation of peroxides andnecrosis of the fungal cell ; direct action on the membrane .RECORDATI Industria Chimica e Farmaceutica S.p.A.Summary of Product CharacteristicDermatological Fenticonazole – January năm ngoái

5.2

Pharmacokinetic properties

An entirely negligible absorption by the transcutaneous route resulted from the pharmacokinetictests, both in animals and humans. After the skin application under an occlusive dressing of 2 %cream or 2 % spray solution of fenticonazole nitrate in humans, the absorption is negligible : lessthan 0.5 % of the administered dose after cream application or 1.62 % after spray application .

5.3

Preclinical safety data

in mice : oral 3000 mg / kg ; i. p. 1276 mg / kg ( M ), 1265 mg / kg ( F ) ;in rats : oral 3000 mg / kg ; s. c. 750 mg / kg ; i. p. 440 mg / kg ( M ), 309 mg / kg ( F ) ;Chronic toxicity : 40-80-160 mg / kg / day by mouth for 6 months in rats and dogs was well tolerated ,except for some mild signs of general toxicity ( increased liver weight in rats at dose of 160 mg / kgwithout other histopathological alterations, and in dogs a transient increase in SGPT at doses of 80and 160 mg / kg associated with increased liver weight ) .LOMEXIN was not mutagenic in 6 mutagenesis tests .LOMEXIN tolerability was satisfactory in guinea pigs and rabbits. Results in dwarf pigs, whoseskin is morphologically and functionally similar to human skin and generally manifests strongsensitivity to various irritants, were excellent .LOMEXIN has shown no signs of sensitisation, phototoxicity or photoallergy .Studies in animals ( rats ) have shown that Fenticonazole does not interfere with the function of maleand female gonads, and does not modify the first phases of reproduction. In addition, with theadministration to rats and rabbits of very high doses of Fenticonazole ( 80 mg / kg ) fetotoxic andembryotoxic effects have occurred. No teratogenic effects were seen in rats or rabbits. In lactatingrats, Fenticonazole and / or its metabolites can be detected in the milk .

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

2% Cream

propylene glycol, wool-fat, hydrogenated, almond oil, refined, polyglycolic ester of fatty acids ,cetyl alcohol, glyceryl monostearate, sodium edetate, purified water .

2% Cutaneous Foam

propylene glycol, alcohol, sodium lauryl ether sulfate solution, alkylamidobetaine solution, purifiedwater .

2% Gel

carbomer, purified water, propylene glycol.

2% Cutaneous solution

alcohol, hydroxypropylcellulose, purified water, propylene glycol .

2% Cutaneous spray solution

alcohol, propylene glycol, purified water

RECORDATI Industria Chimica e Farmaceutica S.p.A.Summary of Product CharacteristicDermatological Fenticonazole – January năm ngoái

2% Cutaneous powder

Silica colloidal hydrated, zinc oxide, talc .

2% Shampoo

Propylene glycol, sodium lauryl ether sulfate solution, alkylamidobetaine solution, purified water .

6.2

Incompatibilities

None .

6.3

Shelf life

3 years. Do not use after expiry date .After opening the primary packaging, period of the shelf life 30 days .

6.4

Special precautions for storage

Store at temperature not exceeding 25 ° C.Keep out of reach of children .

6.5

Nature and contents of container, packaging

– 2% cream: 1 tube of 10 g, 15 g, 20 g, 30 g, 40 g, 50 g.

– 2% cutaneous spray solution: one 30 ml glass container

– 2% cutaneous powder: one polypropylene tube of 50 g

Pharmaceutical forms currently marketed are reported only ; not all the pack sizes may be marketed .

6.6

Instructions for use/handling

7.

MARKETING AUTHORIZATION HOLDER

Recordati Ireland Ltd .Raheens East, Ringaskiddy, Co. Cork, Ireland

8.

MARKETING AUTHORIZATION NUMBER

9.

DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

10.

DATE OF (PARTIAL) REVISION OF THE TEXT

January năm ngoái

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