Canesten Unidie Cream 30 gr 1%

WARNINGS
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena that manifest themselves with redness and itching; in this case, it is necessary to interrupt the treatment and institute a suitable therapy. The same will be done in case of development of resistant microorganisms. Patients with known hypersensitivity reactions to other imidazole antifungals (eg econazole, clotrimazole, miconazole) should use medicinal products containing bifonazole with caution.
PHARMACOTHERAPEUTIC CATEGORY
Topical antifungals.
STORAGE
Store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients.
NAME
CANESTEN UNIDIE 1% CREAM
EXCIPIENTS
Sorbitan monostearate; polysorbate 60; spermaceti; cetylstearyl alcohol; octyldodecanol; benzyl alcohol; purified water.
SIDE EFFECTS
The following adverse reactions are derived from post-marketing spontaneous reports and it is not possible to define their frequency. General disorders and administration site conditions: administration site pain, peripheral edema (administration site). Skin and subcutaneous tissue disorders: contact dermatitis, allergic dermatitis, erythema, pruritus, rash, hives, blisters, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, burning sensation. These side effects are reversible after discontinuation of treatment. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING
Preclinical safety data and human pharmacokinetic data do not give any indication on the effects on mother and child when using bifonazole during pregnancy. It is best to avoid the use of bifonazole during the first trimester of pregnancy. Milk excretion has been studied in animals. Available pharmacodynamic / toxicology data in animals have shown that bifonazole and its metabolites pass into breast milk. It is not known whether bifonazole is excreted in human milk. Breastfeeding should be discontinued during treatment with bifonazole. Preclinical studies have not shown any impairment of male or female fertility.
INDICATIONS
Treatment of dermatomycoses caused by dermatophytes, saccharomycetes, other pathogenic fungi: mycosis of the foot and hand, mycosis of the trunk (tinea corporis), mycosis of the skin folds (tinea inguinalis), onychomycosis, pityriasis versicolor, superficial candidiasis.
INTERACTIONS
Available data suggest a possible interaction between topical bifonazole and warfarin with increased prothrombin time. If the medicine is used in warfarin-treated patients, they should be monitored appropriately.
DOSAGE
For the purpose of complete recovery, controlled and sufficiently prolonged use of the drug is essential. However, it is advisable not to interrupt therapy immediately after the disappearance of the acute inflammatory manifestations and subjective symptoms, but to adhere to the following average treatment times, depending on the type of infection, the extent and location of the infection itself. Foot mycosis (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. Superficial candidiasis: 2-4 weeks. Method of administration: unless otherwise prescribed, the medicine should be applied in small quantities on the infected parts with a light massage once a day, preferably in the evening before going to bed. A small amount of cream is generally sufficient to treat a surface approximately equal in size to the palm of the hand. Pediatric population: in pediatric age, safety and efficacy of the product have not been demonstrated; until sufficient data are acquired, the use of the product in such subjects is not indicated.
ACTIVE PRINCIPLES
Bifonazole.