Ifenec

Italy
Brand name Ifenec
Form cream
Active substance / Dosage
ECONAZOLE NITRATE
Prescription type Non-prescription – not available over the counter
ATC code
D01AC03
Registration number 024066
Manufacturer ITALFARMACO S.P.A.
Ifenec cream

IFENEC 1% cream
IFENEC 1% cutaneous emulsion
IFENEC 1% cutaneous powder
IFENEC 1% cutaneous solution
econazole
PHARMACOTHERAPEUTIC CATEGORY
Antifungal agent for the local treatment of all fungal infections.

THERAPEUTIC INDICATIONS
Cream, cutaneous powder, cutaneous emulsion
Fungal infections of the skin and its appendages, even when complicated by superinfections with 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 intended for topical use only.
In the earliest infancy, the product should be administered only when strictly necessary and under direct medical supervision.
Ifenec is not indicated for ophthalmic or oral use.

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

SPECIAL WARNINGS
Topical medicinal products, especially when used for prolonged treatments, may cause sensitization phenomena. If this occurs, treatment must be discontinued and appropriate therapy initiated. Patients sensitive to imidazoles may also be sensitive to econazole nitrate.

Pregnancy and lactation
Due to systemic absorption, Ifenec must not be used during the first trimester of pregnancy unless the physician considers it necessary for the patient's health.
Ifenec may be used during the second and third trimesters of pregnancy if the potential benefit to the mother outweighs the possible risks to the fetus.
Use Ifenec with caution in nursing women.

Effects on ability to drive vehicles and use of machinery
Not known.

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

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Cream, cutaneous emulsion, cutaneous powder
Apply to the affected area twice daily. Use Ifenec cream (for scalp and hairy areas, use Ifenec cutaneous emulsion).
For the treatment of onychomycosis, cover the area with an occlusive dressing.
Use cutaneous powder for moist infections, 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. Wet the entire body and apply the contents of one sachet of Ifenec using a sponge.
Rub in for several minutes (3–5), then allow the solution to dry without rinsing. A water-only shower is permitted the following morning, allowing the medicine to act on the entire body surface overnight.
If pityriasis versicolor has not cleared within 15 days after completing treatment, a second treatment cycle should be repeated. To prevent relapses and reinfections, repeat treatment every 1–3 months.

OVERDOSE
Ifenec is for cutaneous application only.
In case of eye contact, rinse thoroughly with clean water or physiological saline and consult a physician if symptoms persist.
In case of accidental ingestion or overdose, nausea, vomiting, and diarrhea may occur and should be treated symptomatically. In any case, immediately contact a physician or the nearest hospital. If in doubt about the use of Ifenec, consult your doctor or pharmacist.

Ifenec 1% cutaneous powder
This formulation contains talc: accidental massive inhalation of the powder may cause airway obstruction, particularly in infants and young children. Respiratory arrest should be treated with supportive therapy and oxygen. If respiration is compromised, consider endotracheal intubation, removal of material, and assisted ventilation.

UNDESIRABLE EFFECTS
Like all medicines, Ifenec can cause adverse effects, although not everyone experiences them.
Common (affects 1 in 10 patients): itching, burning sensation of the skin.
Uncommon (affects 1 in 100 patients): erythema, malaise, swelling.
Frequency not known (frequency cannot be determined from available data): pain, angioedema, contact dermatitis, skin rash, urticaria, vesiculation, skin exfoliation, and hypersensitivity.
The use of topical medicines, especially if prolonged, may lead to sensitization phenomena. If this occurs, discontinue treatment and consult a physician. In case of particularly intense local reactions, discontinue treatment and consult a physician.
In very rare cases, local irritation may occur in eczematous areas: in such cases, precede therapy with Ifenec by a few days of anti-eczematous treatment.
Following the instructions in the package leaflet reduces the risk of adverse effects.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system: www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse effects, you help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
Do not use the product after the expiry date stated on the packaging.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
Keep the medicine out of the sight and reach of children.

COMPOSITION
Cream
100 g of cream contains:
Active substance
econazole nitrate 1.00 g
Excipients
polyoxyethylene palmitostearate; polyoxyethylene saturated fatty acid glycerides; liquid paraffin; benzoic acid; butylhydroxyanisole; purified water.

Cutaneous emulsion
100 g of emulsion contains:
Active substance
econazole nitrate 1.00 g
Excipients
polyoxyethylene palmitostearate; liquid paraffin; polyoxyethylene saturated fatty acid glycerides; precipitated silica; benzoic acid; butylhydroxyanisole; purified water.

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

Cutaneous solution
100 g of solution contains:
Active substance
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: box of 3 or 6 single-dose sachets of 10 g
Not all pack sizes may be marketed.

MARKETING AUTHORIZATION 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 - Milano
Cutaneous solution
VAMFARMA S.R.L.
Via Kennedy 5
26833 Comazzo (LODI)
Packaging into 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
IFENEC 50 mg ovules
IFENEC 150 mg ovules
IFENEC 1% cutaneous solution for external genitals
econazole
PHARMACOTHERAPEUTIC CATEGORY
Antifungal agent for the local treatment of fungal infections of the vulvo-vaginal region.

THERAPEUTIC INDICATIONS
Fungal vulvo-vaginal infections, even when complicated by superinfections with Gram-positive germs.

CONTRAINDICATIONS
Hypersensitivity to econazole or to any of the excipients.

PRECAUTIONS FOR USE
Ifenec vaginal cream and Ifenec ovules are for intravaginal use only. Ifenec is not for ophthalmic or oral use.
Concurrent use of latex condoms or diaphragms with vaginal antimicrobial preparations may reduce the effectiveness of latex contraceptives. Therefore, products such as Ifenec should not be used together with diaphragms or latex condoms. Patients using spermicides should consult their doctor, as any local vaginal treatment may inactivate spermicides.
Ifenec must not be used together with other products for internal or external treatment of the genital area.

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

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

Pregnancy and lactation
Due to vaginal absorption, Ifenec must not be used during the first trimester of pregnancy unless the physician considers it necessary for the patient's health. Ifenec may be used during the second and third trimesters if the potential benefit outweighs the possible risks to the fetus.
Use Ifenec with caution in nursing women.

Effects on ability to drive vehicles and use of machinery
Not known.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Vaginal cream and 50 mg ovules
Insert deeply into the vagina, preferably while lying down, one applicator filled with vaginal cream (5 cc) or one IFENEC ovule every evening before bedtime for 15 days. Treatment should continue even after the disappearance of itching and white discharge.

150 mg ovules
Insert one 150 mg ovule deeply into the vagina, preferably while lying down, every evening before bedtime for 3 consecutive days. If the fungal infection has not cleared one week after treatment, repeat the treatment.

Cutaneous solution for external genitals
This pharmaceutical form should be used as a complementary therapy to IFENEC vaginal cream and ovules.
Clean the external genital area with 10 cc (1 dose) of cutaneous solution diluted in warm water.
Treatment may be performed once or twice daily.

Prophylactic treatment of the partner
Both the vaginal cream and the cutaneous solution for external genitals may be used.
Apply the cream to the genital organ once daily for 15 consecutive days, after washing the area with warm water.
Use the solution diluted in warm water. Do not rinse after treatment.
Note: IFENEC does not stain underwear.

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

UNDESIRABLE EFFECTS
Like all medicines, Ifenec can cause adverse effects, although not everyone experiences them.
Common (affects 1 in 10 patients): itching, burning sensation of the skin.
Uncommon (affects 1 in 100 patients): skin rash, vulvovaginal burning sensation.
Rare: erythema.
Frequency not known (frequency cannot be determined from available data): hypersensitivity, angioedema, urticaria, contact dermatitis, skin exfoliation, and application site reactions such as pain, irritation, and swelling.
In hypersensitive individuals, use of the medicine may lead to sensitization or local irritative phenomena, as well as pelvic cramps, skin rashes, and headache. In such cases, consult the treating physician, who will assess whether to discontinue treatment or adopt appropriate therapeutic measures.
Following the instructions in the package leaflet reduces the risk of adverse effects.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system: /www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse effects, you help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
Storage:
Ovules: do not store above 30°C.
Vaginal cream: do not store above 25°C.
ATTENTION: DO NOT USE THE MEDICINE AFTER THE EXPIRY DATE INDICATED ON THE PACKAGING.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

COMPOSITION
Vaginal cream
100 g of cream contains:
Active substance
Econazole nitrate 1.0 g
Excipients
Polyoxyethylene palmitostearate, polyoxyethylene saturated fatty acid glycerides, liquid paraffin, benzoic acid, butylhydroxyanisole, purified water.

50 mg ovules
Each ovule contains:
Active substance
Econazole nitrate 50.0 mg
Excipients
Semisynthetic glycerides

150 mg ovules
Each ovule contains:
Active substance
Econazole nitrate 150.0 mg
Excipients
Semisynthetic glycerides

Cutaneous solution for external genitals
100 ml of solution contains:
Active substance
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
Ovules: 6 ovules of 50 mg
12 ovules of 50 mg
15 ovules of 50 mg
3 ovules of 150 mg
6 ovules of 150 mg
1% cutaneous solution for external genitals: 1 bottle of 60 ml
Not all pack sizes may be marketed.

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

MANUFACTURER
50 mg and 150 mg ovules
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)