CANESTEN UNIDIC CREMA 30G 1%

CANESTEN UNIDIE 1% CREMA

active ingredients

1% cream 100 g cream contain: active ingredient: bifonazole 1 g Excipients with known effects: cetilstearilic alcohol, monostearate sorbitan, polysorbate 60, benzilic alcohol. For the full list of excipients see 6.1

Excellent

1% cream monostearate sorbitan polysorbed 60 sperm cetilsteari alcohol octildocanolo alcohol benzig purified water

Therapeutic indications

Treatment of dermatomycosis supported by dermatophytes, by saccaromycetes, by other pathogenic fungi: mycosis of the foot and of the hand, mycosis of the trunk (tinea corporis), mycosis of the skin folds (tinea inguinalis), onicomicosi, pityriasis versicolor, candid superficial.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1.

Population

For the purposes of complete healing, the controlled and sufficiently prolonged use of Canesten Unidie is indispensable. However, it is recommended not to stop therapy immediately after the disappearance of acute flogistic manifestations and subjective symptomatology, but to stick to the following average treatment times, depending on the type of infection, extension and location of the infection itself:

Indications	Duration of treatment
Mycosis of the foot (Tinea pedis, tinea pedum interdigitalis)	3 weeks
Mycosis of the trunk, hands and skin folds (Tinea corporis, tinea manuum, tinea inguinalis)	2-3 weeks
Pityriasis versicolor	2 weeks
Surface Candidosis	2-4 weeks

Method of administration Unless otherwise prescribed, Canesten Unidie should be applied in small quantities on infected parts with a slight massage once a day, preferably in the evening before bedtime. A small amount of cream is generally sufficient to treat a size surface about equal to the palm of the hand. Pediatric population In pediatric age, safety and effectiveness of Canesten Unidie have not been demonstrated; until sufficient data is acquired, the use of the product in such subjects is not indicated.

Conservation

No particular condition

Warnings

The use, especially if prolonged, of products for topical use, can give rise to phenomena of sensitization that manifest with redness and itching; in such case, it is necessary to stop treatment and establish suitable therapy. We will also be involved in the development of resistant microorganisms. Patients with proven hypersensitivity reactions to other imidazolic antifungals (e.g. econazole, clotrimazole, miconazole) must use medicinal products containing bifonazole with caution. Canesten Unidie contains cetilstearilic alcohol: can cause local skin reactions (e.g. contact dermatitis). Canesten Unidie contains monostearate sorbitan: can cause local skin reactions (e.g. contact dermatitis). Canesten Unidie contains 20mg/g benzyl alcohol: - can cause allergic reactions; - can cause slight local irritation. Canesten Unidie contains polysorbed 60: can cause local skin reactions (e.g. contact dermatitis). Avoid contact with eyes Do not ingest

Interactions

The available data suggest a possible interaction between bifonazole by topical and warfarin with increased protrombine time. If Canesten Unidie is used in patients with warfarin therapy, these should be properly monitored.

Effects

The following adverse reactions arise from post-marketing spontaneous signals and it is not possible to define the frequency. Systemic pathologies and conditions for administration Pain in administration, peripheral edema (in administration). Pathologies of skin and subcutaneous tissue Contact dermatitis, allergic dermatitis, erythema, itching, rash, hives, hives, skin exfoliation, eczema, dry skin, irritation of the skin, skin maceration, burning sensation. These side effects are reversible after suspension of treatment. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There are no overdose cases.

Pregnancy Preclinical safety data and pharmacokinetics data on man, give no indication of the effects for the mother and child when using bifonazole during pregnancy (see paragraph 5.3). It is better to avoid the use of bifonazole during the first trimester of pregnancy. Food Excretion in milk was studied in animals. The pharmacodynamic/toxicology data available in animals have shown that bifonazole and its metabolites pass into breast milk (see paragraph 5.3). It is not known whether bifonazole is excreted in human milk. Breastfeeding should be stopped during treatment with bifonazole. Fertility Preclinical studies have not shown impairment of male or female fertility (see paragraph 5.3)

Source: Farmadati