Clotrimazole 1% - cream for the treatment of cutaneous mycoses 30 g

Product Description

Clotrimazole Doc 1% Cream

Composition

100 g of cream contain: 1 g of clotrimazole. Excipient with known effect: cetostearyl alcohol. For the full list of excipients, see section 6.1.

Excipients

Sorbitan monostearate, polysorbate 60, spermaceti, cetylstearyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water.

Therapeutic indications

Mycoses of the skin and skin folds, such as pityriasis versicolor, cutaneous candidiasis, tinea pedis or athlete's foot, tinea corporis.

Contraindications

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

Posology

CLOTRIMAZOLE DOC Generici 1% cream should be applied in small quantities 2-3 times a day to the affected area, rubbing lightly, after having washed and dried the area thoroughly. Half a cm of cream is sufficient to treat an area the size of a hand. CLOTRIMAZOLE DOC Generici 1% cream is especially indicated for the treatment of glabrous (hairless) skin areas. Generally, a continuous treatment period of three to four weeks is sufficient for the symptoms to disappear. In order to consolidate the therapeutic results obtained and avoid reinfections, it is advisable to continue therapy with CLOTRIMAZOLE DOC Generici 1% cream for at least 2 weeks after the symptoms have disappeared.

Warnings and precautions

Avoid contact with eyes. Do not ingest. The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In case of hypersensitivity reactions, it is necessary to discontinue treatment, consult a doctor or pharmacist and institute appropriate therapy. In diaper rash, the use of "occlusive" diapers after applying the cream is not recommended. In case of recurrence, consult your doctor. After three or four weeks of continuous use without appreciable results, consult your doctor. To avoid recurrences, which are very common in mycosis, it is advisable to inform the patient to observe some basic hygiene rules: frequent changing of underwear; towels and their chemical or thermal disinfection; avoiding promiscuity of clothing and linen. Important information about some excipients: CLOTRIMAZOLE DOC Generici cream contains cetistearyl alcohol, which can cause local skin reactions (e.g. contact dermatitis).

Interactions

No interactions have been reported in common relevant therapies.

Undesirable effects

The following adverse reactions have been identified after the approval of clotrimazole. Since these reactions derive from spontaneous reports from a population of uncertain size, it is not always possible to determine their frequency. Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria). Skin and subcutaneous tissue disorders: blisters, discomfort/pain, edema, erythema, irritation, desquamation, pruritus, rash, burning. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization 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 www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Fertility No studies on the effects of clotrimazole on fertility have been conducted in humans; however, animal studies have shown no effects of the drug on fertility. Pregnancy: There are limited data on the use of clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, the use of clotrimazole should be avoided during the first trimester of pregnancy. Breastfeeding: Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk (see section 5.3). Breastfeeding should be discontinued during treatment with clotrimazole.