CANESTEN CREMA 30G 1%

CANESTEN 1%

active ingredients

Canesten 1% cream 100 g contain: active ingredient clotrimazole: 1 g. Excipients with known effects: cetosterial alcohol, benzilic alcohol. Canesten 1% skin spray, solution 100 ml contain: active ingredient clotrimazole: 1 g. Excipient with known effects: glycol propylene. Canesten 1% skin powder 100 g of powder contain: active ingredient clotrimazole: 1 g. For the full list of excipients see paragraph 6.1.

Excellent

Canesten 1% cream: sorbitan stearate; polysorbed 60; cetil palmitato; cetostearilic alcohol; octildodecanol; benzig alcohol; purified water. Canesten 1% skin spray, multidose container solution with dosing pump: macrogol 400; isopropanol; propilen glycol. Canesten 1% cutaneous powder: rice starch.

Therapeutic indications

Cream and skin spray solution Mycosis of skin and skin folds, such as skin pythriasis, candid skin, tinea pedis or athlete's foot, tinea corporis. Skin powder Topical treatment of wet skin mycosis and skin folds especially if located in covered or poorly aerated areas (for example: tinea pedis or athlete's foot, tinea cruris, tinea inguinalis).

Contraindications

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

Population

Cream Canesten cream should be applied in small quantity 2-3 times a day in correspondence of the sliced area, frying slightly, after washing and drying thoroughly the part. Half cm of cream is enough to treat a surface of the size of a hand. The cream is selectively indicated for the treatment of glabrous skin areas (without hair). Skin spray solution The skin spray solution is useful for treating skin areas covered by hair and skin folds. It is also indicated for the application on large areas of the body (schiena, abdomen, chest). Canesten spray cutaneous solution must be sprayed evenly on the part to be treated 2 times a day. Skin powder Canesten powder should be applied 2-3 times a day, after thoroughly washing and drying the affected area. In the athlete’s foot it is recommended to sprinkle with Canesten powder also the inside of the socks and shoes. Generally for the disappearance of events, 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 therapy with Canesten for at least two 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 phenomena of awareness. In such case, you must stop treatment and consult your doctor or pharmacist. In diaper dermatitis we do not recommend the use of occlusive diapers after the application of the drug. In case of relapse consult your doctor. After three to four weeks of continuous use without appreciable results, consult your doctor. Canesten skin spray solution: avoid spraying in the eyes. Important information about some excipients Canesten cream contains: • cetosterial alcohol that can cause local skin reactions (e.g. contact dermatitis); • 20 mg/g of benzyl alcohol: - can cause allergic reactions; - can cause slight local irritation. Canesten Spray 1% cutaneous solution (multidose container with dosing pump) contains 546 mg/ml of glycol propylene: - can cause skin irritation. As this medicine contains glycol propylene, do not use it on open wounds or extended areas of damaged skin (such as burns) without having talked to the doctor or pharmacist.

Interactions

No note

Effects

The following adverse reactions were identified after the approval of clotrimazole. Since such reactions arise from spontaneous signalling by a population of unsure size, the frequency cannot be defined on the basis of the available data. Immune system disorders: angioedema, anaphylactic reaction, hypersensitivity Vascular pathologies: hypotension, syncope. Respiratory, chest and mediastinic pathologies: dispnea Pathologies of skin and subcutaneous tissue: bubbles, contact dermatitis, erythema, parestesia, skin dequamation, itching, skin rash, hives, pungent skin pain, skin burning sensation. Systemic pathologies and conditions for administration: irritation to the application site, reaction to the application site, edema, pain. 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 professionals are required to report any adverse reaction suspected through the national reporting system of the Italian Agency of the Pharmaco Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 under 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 Clinical data in pregnant women are limited, animal studies show no harmful effects or indirect effects in terms of reproductive toxicity (see Preclinical Safety Data). Clotrimazole can be used during pregnancy. However, during the first trimester of pregnancy, it is recommended to start treatment only under medical control. Food Data on excretion of clotrimazole in breast milk are not available. However, systemic absorption is minimal after topical administration and is unlikely to occur systemic effects. Clotrimazole can be used during breastfeeding. If used locally on the nipple area, wash the breast before breastfeeding the baby.

Source: Farmadati