IFENEC 1% Крем

Содержание инструкции

1. IFENEC 1% cream, 1% cutaneous emulsion, 1% cutaneous powder, 1% cutaneous solution
2. IFENEC 1% vaginal cream, 50 mg vaginal suppositories

IFENEC 1% cream, 1% cutaneous emulsion, 1% cutaneous powder, 1% cutaneous solution

econazole
PHARMACOTHERAPEUTIC CATEGORY
Antimycotic for the local treatment of all mycotic infections

THERAPEUTIC INDICATIONS

Cream, cutaneous powder, cutaneous emulsion
Mycotic infections of the skin and its appendages, even if complicated by superinfections from Gram-
positive germs.

Cutaneous solution
Pityriasis versicolor.

CONTRAINDICATIONS
Hypersensitivity to econazole or to any of the excipients.

PRECAUTIONS FOR USE
All pharmaceutical forms of Ifenec are indicated only for cutaneous use.
In early infancy, the product should be administered only when absolutely necessary, under the direct
supervision of a doctor.
Ifenec is not indicated for ophthalmic or oral use.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
available without a prescription. Cases of interaction with oral anticoagulants, such as
warfarin and acenocoumarol have been reported. In patients undergoing therapy with oral anticoagulants, caution is advised and
their anticoagulant effect should be monitored more frequently. An adjustment of the dosage of the oral
anticoagulant drug may be necessary during treatment with econazole and after its
discontinuation.

SPECIAL WARNINGS
Medicines for cutaneous use, especially if used for prolonged treatments, can cause
sensitization phenomena. If this occurs, treatment should be discontinued and appropriate
therapy should be instituted. Patients sensitive to imidazoles may be sensitive to econazole nitrate.

Pregnancy and breastfeeding
Due to systemic absorption, Ifenec should not be used during the first trimester of
pregnancy unless the doctor considers it necessary for the patient's health.
Ifenec can be used during the second and third trimesters of pregnancy if the potential benefit
for the mother outweighs the possible risks to the fetus.
Use Ifenec with caution in breastfeeding patients.

Effects on ability to drive and use machines
Not known.

Important information about some excipients of Ifenec
The medicine contains benzoic acid which may be slightly irritating to the skin, eyes and
mucous membranes.
Econazole nitrate powder contains talc. Avoid inhalation to prevent irritation of the airways,
especially in children and infants.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT

Cream, cutaneous emulsion, cutaneous powder
Apply to the lesion, twice a day, Ifenec cream (use Ifenec
cutaneous emulsion on the scalp and in hairy areas).
In the treatment of onychomycosis, cover with an occlusive dressing.
Use the cutaneous powder in humid infections, in interdigital mycoses and for daily disinfection
of socks and the inside of shoes.

Cutaneous solution
The medicine should be used, for at least three consecutive evenings, as a bath solution
by sprinkling the entire body, previously wetted, with a sponge on which the
contents of one sachet of Ifenec have been poured.
Rub for a few minutes (3-5) then allow the solution to dry without rinsing: a shower with water only is allowed the following morning; in this way the medicine has the possibility of carrying out
its action on the entire body surface throughout the night.
If, 15 days after the end of therapy, Pityriasis versicolor has not yet been eradicated, it is
advisable to repeat a second cycle of treatment. In any case, in order to avoid relapses and reinfections,
it is recommended to repeat the treatment after 1-3 months.

OVERDOSE
Ifenec is only for cutaneous application.
In case of contact with the eyes, rinse with clean water or physiological solution and consult a
doctor if symptoms persist.
In case of ingestion/accidental intake of an excessive dose of Ifenec, nausea, vomiting and diarrhea may occur, to be treated with symptomatic therapy, however, in any case, immediately warn
the doctor or go to the nearest hospital. If you have any doubts about the use of
Ifenec, consult your doctor or pharmacist.
Ifenec 1% cutaneous powder
The powder formulation contains talc: massive accidental inhalation of the powder can
cause blockage of the airways, especially in infants and children. Respiratory arrest must be
treated with supportive therapy and oxygen. If breathing is compromised, the following measures should be considered: endotracheal intubation, removal of the material and assisted ventilation.

UNDESIRABLE EFFECTS
Like all medicines, Ifenec can cause side effects, although not everybody gets them.
Common (affecting 1 in 10 people): itching, burning sensation of the skin.
Uncommon (affecting 1 in 100 people): erythema, discomfort and swelling.
Frequency not known (frequency cannot be estimated from available data): pain,
angioedema, contact dermatitis, rash, urticaria, blistering, skin exfoliation
and hypersensitivity.
The use of medicines for cutaneous use, especially if prolonged, can cause sensitization phenomena, if this occurs, stop the treatment and consult your doctor. In case of
particularly intense local reactions, it is necessary to stop the treatment and consult a doctor.
In very rare cases, local irritation is possible in eczematous areas: in such situations, precede the therapy with Ifenec for a few days with an anti-eczematous treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide 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 product after the expiry date reported on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 25°C.
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

Cream
100 g of cream contains:
Active ingredient
econazole nitrate 1.00 g
Excipients
polyoxyethylene glycol palmitostearate; polyoxyethylenated glycerides of saturated fatty acids; liquid paraffin; benzoic acid; butylated hydroxyanisole; purified water.

Cutaneous emulsion
100 g of emulsion contains:
Active ingredient
econazole nitrate 1.00 g
Excipients
polyoxyethylene glycol palmitostearate; liquid paraffin; polyoxyethylenated glycerides of saturated fatty acids; precipitated silica; benzoic acid; butylated hydroxyanisole; purified water.

Cutaneous powder
100 g of powder contains:
Active ingredient
econazole nitrate 1.00 g
Excipients
zinc oxide; precipitated silica; talc.

Cutaneous solution
100 g of solution contains:
Active ingredient
econazole 1.00 g
Excipients
polysorbate 20; benzyl alcohol; sorbitan monolaurate; water-sodium tridecyl ether sulfate-sodium
lauroamphoacetate; polyethylene glycol 6000 distearate; purified water.

PHARMACEUTICAL FORM AND PACKAGING
1% cream: 1 tube of 30 g
1% cutaneous emulsion: 1 tube of 30 g
1% cutaneous powder: 1 bottle of 20 g
1% cutaneous powder: 1 bottle of 30 g
1% cutaneous solution: pack of 3 or 6 single-dose sachets of 10 g
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
ITALFARMACO S.p.A. - Viale Fulvio Testi, 330 - 20126 MILAN

MANUFACTURER

Cutaneous emulsion
BELTAPHARM SPA
VIA STELVIO, 66
20095 CUSANO MILANINO (MI)

Cutaneous powder
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - Milan

Cutaneous solution
VAMFARMA S.R.L.
Via Kennedy 5
26833 Comazzo (LODI)
Packaging in sachets
c/o Ivers Lee S.p.A. - Corso della Vittoria, 1533 - Caronno Pertusella (VA)

Cream
BELTAPHARM SpA
Via Stelvio, 66
20095 Cusano Milanino (MI)
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Via Licinio 11, 22036 Erba (CO)

IFENEC 1% vaginal cream, 50 mg vaginal suppositories

IFENEC 150 mg vaginal suppositories
IFENEC 1% cutaneous solution for external genitals
econazole
PHARMACOTHERAPEUTIC CATEGORY
Antimycotic for the local treatment of mycotic infections of the vulvo-vaginal region.

THERAPEUTIC INDICATIONS
Vulvo-vaginal mycotic infections, even if complicated by superinfections with Gram-positive germs.

CONTRAINDICATIONS
Hypersensitivity to econazole or any of the excipients

PRECAUTIONS FOR USE
Ifenec vaginal cream and Ifenec suppositories are for intravaginal use only. Ifenec is not for ophthalmic or
oral use.
The simultaneous use of latex condoms or diaphragms with vaginal antimicrobial preparations may
decrease the effectiveness of latex contraception. Therefore, products like Ifenec should not be used
together with diaphragms or latex condoms. Patients who use spermicides should consult their
doctor because any local vaginal treatment may inactivate the
spermicide.
Ifenec should not be used together with other products for the treatment, internal or external, of the genitals.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
available without a prescription. Cases of interaction with oral anticoagulants, such as
warfarin and acenocoumarol, have been reported.
In patients undergoing therapy with oral anticoagulants, caution is required and the anticoagulant effect
should be monitored more frequently. An adjustment of the dosage of the oral anticoagulant drug
may be necessary during treatment with econazole and after its discontinuation.

SPECIAL WARNINGS
If sensitization or marked irritation occurs, treatment should be
discontinued.
Patients sensitive to imidazoles may be sensitive to econazole nitrate.

Pregnancy and breastfeeding
Due to vaginal absorption, Ifenec should not be used during the first trimester of pregnancy unless the doctor considers it necessary for the health of the patient. Ifenec can be used
during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus.
Use Ifenec with caution in breastfeeding patients.

Effects on ability to drive and use machines
Not known.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Vaginal cream and 50 mg suppositories
Introduce deeply into the vagina, preferably in a lying position, an applicator filled with
vaginal cream (5 cc) or one IFENEC suppository every evening before bedtime, for 15 days. Treatment
should be continued even after the disappearance of itching and white discharge.
150 mg suppositories
Introduce deeply into the vagina, preferably in a lying position, one 150 mg suppository every evening
before bedtime, for 3 consecutive days. If after one week from treatment the mycosis does not
resolve, repeat the treatment.
Cutaneous solution for external genitals
This pharmaceutical form should be used as a complementary therapy to IFENEC vaginal
cream and suppositories.
Cleanse the external genitals with 10 cc (1 dose) of cutaneous solution dissolved in warm water.
Treatment can be carried out once or twice a day.
Prophylactic treatment of the partner
Both vaginal cream and cutaneous solution for external genitals can be used.
The cream is applied to the genital organ once a day for 15 consecutive days, after washing the
area with warm water.
The solution is used dissolved in warm water. After treatment, do not rinse.
Note: IFENEC does not stain laundry.

OVERDOSAGE
The available pharmaceutical forms are intended exclusively for local application. In case of
accidental ingestion, nausea, vomiting, diarrhea and other adverse reactions listed in
paragraph 4.8 may occur and should be treated with symptomatic therapy.
If the medicine is accidentally applied to the eyes, wash with clean or saline water and
consult a doctor if symptoms persist.

UNDESIRABLE EFFECTS
Like all medicines, Ifenec can cause side effects, although not everybody gets them.
Common (present in 1 patient in 10): itching, burning sensation of the skin.
Uncommon (present in 1 patient in 100): skin rash, vulvovaginal burning sensation.
Rare: erythema.
Frequency not known (frequency cannot be estimated on the basis of available data): hypersensitivity,
angioedema, urticaria, contact dermatitis, skin exfoliation and reactions at the site of application
such as pain, irritation and swelling.
In hypersensitive subjects, the use of the medicine may give rise to local sensitization or irritative
phenomena, as well as pelvic cramps, skin rashes and headache. In such cases, the treating doctor
should be consulted, who will assess the appropriateness of interrupting treatment or adopting suitable therapeutic measures.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system /www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
Storage. Suppositories: do not store at temperatures above 30°C.
Vaginal cream: do not store at temperatures above 25°C.
WARNING: DO NOT USE THE MEDICINE AFTER THE EXPIRY DATE INDICATED ON THE
PACKAGING.
The expiry date indicated refers to the product in intact packaging, stored correctly.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

COMPOSITION

Vaginal cream
100 g of cream contains:
Active ingredient
Econazole nitrate 1.0 g
Excipients
Polyoxyethylene glycol palmitostearate, polyoxyethylenated glycerides of saturated fatty acids, liquid paraffin, benzoic acid, butylated hydroxyanisole, purified water.

50 mg suppositories
Each suppository contains:
Active ingredient
Econazole nitrate 50.0 mg
Excipients
Semi-synthetic glycerides

150 mg suppositories
Each suppository contains:
Active ingredient
Econazole nitrate 150.0 mg
Excipients
Semi-synthetic glycerides

Cutaneous solution for external genitals
100 ml of solution contains:
Active ingredient
Econazole 1.0 g
Excipients
Polysorbate 20, benzyl alcohol, sorbitan monolaurate, N-hydroxyethyl-N-coco alkylamidoglycinate, sodium salt, polyoxyethylene glycol 6000 distearate, lactic acid, purified water.

PHARMACEUTICAL FORM AND PACKAGING
1% vaginal cream: tube of 78 g + applicator
1% vaginal cream: tube of 30 g + applicator
Suppositories: 6 suppositories of 50 mg
12 suppositories of 50 mg
15 suppositories of 50 mg
3 suppositories of 150 mg
6 suppositories of 150 mg
1% cutaneous solution for external genitals: 1 bottle of 60 ml
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - Milan

MANUFACTURER

50 and 150 mg suppositories
Lamp San Prospero – Via della Pace 25/A – San Prospero S/S (MO)
Italfarmaco S.p.A. – Viale Fulvio Testi, 330 (MI)

Cutaneous solution for external genitals
VAMFARMA S.R.L.
Via Kennedy 5
26833 Comazzo (LODI)

Vaginal cream
Francia Farmaceutici – Via Pestagalli 7 – Milan
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Via Licinio 11, 22036 Erba (CO)