CLOTRIMAZOLO DOC CREMA 30G 1%

CLOTRIES DOC GENERICI 1% CREMA

active ingredients

100 g cream contain: clotrimazole 1 g. Excipient with known effects: cetostearilic alcohol. For the complete list of excipients, see paragraph 6.1.

Excellent

Sorbitan monostearate, polysorbate 60, spermacetes, cetilstearilic alcohol, 2–ottildodecanol, benzilic alcohol, purified water.

Therapeutic indications

Mycosis of skin and skin folds, such as pythriasis versicolor, candid skin, tinea pedis or athlete's foot, tinea corporis.

Contraindications

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

Population

Generic CLOTRIMAZOLO DOC 1% cream should be applied in small quantity 2–3 times a day in correspondence of the sliced area, frying slightly, after washing and drying the part thoroughly. Half cm of cream is enough to treat a surface of the size of a hand. Generic CLOTRIMAZOLO DOC 1% cream is especially suitable for treating glabrous skin areas (without hair). Generally, for the disappearance of manifestations, a period of treatment without interruption of three to four weeks is sufficient. In order to consolidate the therapeutic results obtained and avoid reinfection, it is appropriate to continue the therapy with CLOTRIMAZOLO DOC Generic 1% cream for at least 2 weeks after the disappearance of the manifestations.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Avoid contact with eyes. Don't swallow. The use, especially if prolonged, of products for topical use can give rise to awareness-raising phenomena. In case of hypersensitivity reactions it is necessary to stop treatment, consult the doctor or pharmacist and establish suitable therapy. In diaper dermatitis we do not recommend the use of diapers with "occlusive" effect_ after the application of the cream. In case of relapse consult your doctor. After three to four weeks of continuous use without appreciable results, consult your doctor. To avoid relapses, very common in mycosis, it is good to inform the patient that he must observe some basic hygiene standards: frequent replacement of underwear; of towels and their chemical or thermal disinfection; avoid promiscuity of clothing and linen. Important information about some excipients CLOTRIMAZOLO DOC General cream contains cetistearilic alcohol, which can cause local skin reactions (e.g. contact dermatitis).

Interactions

No interactions have been reported in the common relevance therapies.

Effects

The following adverse reactions were identified after the approval of clotrimazole. Since such reactions arise from spontaneous signalling by a population of not certain size, it is not always possible to define their frequency. Immune system disorders: allergic reaction (syncope, hypotension, dispnea, hives). Pathologies of skin and subcutaneous tissue: bubbles, discomfort/dolore, edema, erythema, irritation, desquamation, itching, rash, burning. 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 www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

There is no risk of acute intoxication since it is unlikely that the same occurs after the single topical application of an overdose (extended application in conditions favourable to absorption) or involuntary oral intake. There is no specific antidote.

Fertility

Human studies have not been conducted on the effects of clotrimazole on fertility; however studies on animals have not shown effects of the drug on fertility.

Pregnancy

There is a limited number of data on the use of clotrimazole during pregnancy. Animal studies show no harmful or direct or indirect effects in terms of reproductive toxicity (see paragraph 5.3). As a precautionary measure, it is appropriate to avoid the use of clotrimazole in the first trimester of pregnancy.

Food

The pharmacodynamic/toxicological data available on animals have shown the secretion of clotrimazole/metabolites in milk (see paragraph 5.3). Breastfeeding must be interrupted during treatment with chlotrimazole.

Source: Farmadati