Canesten Unidie 1% cream 30g

Canesten Unidie 1% Cream is a topical antifungal based on clotrimazole , indicated for the treatment of skin infections caused by fungi, yeasts and dermatophytes . It is particularly effective in combating athlete's foot, tinea corporis, cutaneous candidiasis and inguinal mycosis , eliminating the microorganisms responsible for the infection and preventing its recurrence.

Its cream formulation ensures easy application and rapid absorption, offering immediate relief from itching, irritation and skin flaking. Thanks to its high efficacy, Canesten Unidie allows you to treat infections with just one application per day, ensuring practical and targeted treatment. The 30g format is ideal for a complete cycle of therapy.

ACTIVE INGREDIENTS

Active ingredients contained in Canesten Unidie 1% cream 30g - What is the active ingredient in Canesten Unidie 1% cream 30g?

1% cream 100 g of cream contain: active ingredient: bifonazole 1 g Excipients with known effect: cetylstearyl alcohol, sorbitan monostearate, polysorbate 60, benzyl alcohol. For a full list of excipients, see 6.1

EXCIPIENTS

Composition of Canesten Unidie 1% cream 30g - What does Canesten Unidie 1% cream 30g contain?

1% cream sorbitan monostearate polysorbate 60 spermaceti cetylstearyl alcohol octyldodecanol benzyl alcohol purified water

DIRECTIONS

Therapeutic indications Canesten Unidie 1% cream 30g - Why is Canesten Unidie 1% cream 30g used? What is it used for?

Treatment of dermatomycosis caused by dermatophytes, saccharomyces, and other pathogenic fungi: foot and hand mycosis, trunk mycosis (tinea corporis), skin fold mycosis (tinea inguinalis), onychomycosis, pityriasis versicolor, superficial candidiasis.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Canesten Unidie 1% cream 30g - When should Canesten Unidie 1% cream 30g not be used?

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

DOSAGE

Quantity and method of taking Canesten Unidie 1% cream 30g - How to take Canesten Unidie 1% cream 30g?

In order to achieve complete healing, controlled and sufficiently prolonged use of Canesten Unidie is essential. However, it is advisable not to interrupt therapy immediately after the disappearance of 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:

Method of administration Unless otherwise prescribed by your doctor, Canesten Unidie should be applied in small quantities to the infected areas 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 an area approximately the size of the palm of the hand. Paediatric population The safety and efficacy of Canesten Unidie have not been demonstrated in paediatric age; until sufficient data are acquired, the use of the product in these subjects is not indicated.

CONSERVATION

Storage Canesten Unidie 1% cream 30g - How to store Canesten Unidie 1% cream 30g?

No particular conditions

WARNINGS

Warnings Canesten Unidie 1% cream 30g - About Canesten Unidie 1% cream 30g it is important to know that:

The use, especially if prolonged, of products for topical use, may give rise to sensitization phenomena that manifest themselves with redness and itching; in this case, it is necessary to interrupt the treatment and institute an appropriate therapy. The same will be done in case of development of resistant microorganisms. Patients with known hypersensitivity reactions to other imidazole antifungals (e.g. econazole, clotrimazole, miconazole) must use medicinal products containing bifonazole with caution. Canesten Unidie contains cetylstearyl alcohol: may cause local skin reactions (e.g. contact dermatitis). Canesten Unidie contains sorbitan monostearate: may cause local skin reactions (e.g. contact dermatitis). Canesten Unidie contains 20 mg/g of benzyl alcohol : - may cause allergic reactions; - may cause slight local irritation. Canesten Unidie contains polysorbate 60: may cause local skin reactions (e.g. contact dermatitis). Avoid contact with eyes. Do not ingest.

INTERACTIONS

Canesten Unidie 1% cream 30g interactions - Which medicines or foods can modify the effect of Canesten Unidie 1% cream 30g?

Available data suggest a possible interaction between topical bifonazole and warfarin with increased prothrombin time. If Canesten Unidie is used in patients receiving warfarin, these should be appropriately monitored.

SIDE EFFECTS

Like all medicines, Canesten Unidie 1% cream 30g can cause side effects - What are the side effects of Canesten Unidie 1% cream 30g?

The following adverse reactions are derived from spontaneous post-marketing reports and it is not possible to estimate their frequency. General disorders and administration site conditions Pain at the administration site, peripheral edema (at the administration site). Skin and subcutaneous tissue disorders Contact dermatitis, allergic dermatitis, erythema, pruritus, rash, urticaria, blisters, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, burning sensation. These undesirable effects are reversible after discontinuation of treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Canesten Unidie 1% cream 30g - What are the risks of Canesten Unidie 1% cream 30g in case of overdose?

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Canesten Unidie 1% cream 30g.

Pregnancy Preclinical safety data and pharmacokinetic data in humans give no indication on the effects on the mother and child when bifonazole is used during pregnancy (see section 5.3). It is best to avoid the use of bifonazole during the first trimester of pregnancy. Breast-feeding Excretion in milk has been studied in animals. Available pharmacodynamic/toxicological data in animals have shown that bifonazole and its metabolites pass into breast milk (see section 5.3). It is not known whether bifonazole is excreted in human milk. Breast-feeding should be discontinued during treatment with bifonazole. Fertility Preclinical studies have not shown any evidence of impairment of male or female fertility (see section 5.3).

DRIVING AND USE OF MACHINERY

Taking Canesten Unidie 1% cream 30g before driving or using machines - Does Canesten Unidie 1% cream 30g affect driving or using machines?

Canesten Unidie has no or negligible influence on the ability to drive and use machines.