CANESTEN * CREAM 30G 1%

CANESTEN * CREAM 30G 1%

Therapeutic indications

Cream and skin spray solutionMycosis of the skin and skin folds, such as pityriasis versicolor, skin candidiasis, tinea pedis or athlete's foot, tinea corporis.Skin powderTopical treatment of moist mycoses of the skin and skin folds especially if located in covered or poorly ventilated areas (for example: tinea pedis or athlete's foot, tinea cruris, tinea inguinalis).

Dosage and method of use

CreamCanesten cream should be applied in small quantities 2-3 times a day in correspondence with the affected area, rubbing lightly, after having thoroughly washed and dried the part. Half a cm of cream is enough to treat a surface the size of a hand. The cream is electively indicated for the treatment of hairless (hairless) skin areas.Skin spray solutionThe skin spray solution is useful for the treatment of skin areas covered by hair and in correspondence with skin folds. It is also suitable for application on large areas of the body (back, abdomen, chest). Canesten cutaneous spray solution should be sprayed evenly on the area to be treated 2 times a day.Skin powderCanesten powder should be applied 2-3 times a day, after having thoroughly washed and dried the affected area. In athlete's foot it is recommended to sprinkle the inside of socks and shoes with Canesten powder. Generally, for the disappearance of the 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 advisable to continue therapy with Canesten for at least two weeks after the disappearance of the manifestations.

Contraindications

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

Side effects

The following adverse reactions were identified after the approval of clotrimazole. Since these reactions arise from spontaneous reports from a population of uncertain size, the frequency cannot be estimated from the available data.Immune system disorders:angioedema, anaphylactic reaction, hypersensitivityVascular disorders:hypotension, syncope.Respiratory, thoracic and mediastinal disorders:dyspneaSkin and subcutaneous tissue disorders:blisters, contact dermatitis, erythema, paraesthesia, skin peeling, itching, rash, hives, stinging skin pain, burning sensation of the skin.General disorders and administration site conditions:application site irritation, application site reaction, edema, pain.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Avoid contact with eyes. Do not swallow. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case, it is necessary to stop the treatment and consult your doctor or pharmacist. In diaper dermatitis, the use of occlusive diapers after application of the drug is not recommended. In case of relapses consult your doctor. After three - four weeks of continuous use without appreciable results, consult your doctor. Canesten skin spray solution: avoid splashing into the eyes.Important information about some of the ingredientsCanesten cream contains: • cetostearyl alcohol which can cause local skin reactions (eg contact dermatitis); • 20 mg / g of benzyl alcohol: - can cause allergic reactions; - may cause slight local irritation. Canesten Spray 1% cutaneous solution (multidose container with dosing pump) contains 546 mg / ml of propylene glycol: - can cause skin irritation. As this medicine contains propylene glycol, do not use it on open wounds or large areas of damaged skin (such as burns) without talking to your doctor or pharmacist.

Pregnancy and breastfeeding

FertilityNo human studies on the effects of clotrimazole on fertility have been conducted; however animal studies have shown no effects of the drug on fertility.PregnancyClinical data in pregnant women are limited, animal studies do not show direct or indirect harmful 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 supervision.Feeding timeThere are no data on the excretion of clotrimazole in breast milk. However, systemic absorption is minimal after topical administration and systemic effects are unlikely. Clotrimazole can be used during breastfeeding. When used topically on the nipple area, wash the breasts before breastfeeding the baby.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

None known

Overdose

No risk of acute intoxication is anticipated as it is unlikely to occur after a single topical application of an overdose (extended application under conditions conducive to absorption) or by inadvertent oral intake. There is no specific antidote.

Active principles

Canesten 1% cream100 g contain:active principleclotrimazole: 1 g. Excipients with known effects: cetostearyl alcohol, benzyl alcohol.Canesten 1% cutaneous spray, solution100 ml contain:active principleclotrimazole: 1 g. Excipient with known effects: propylene glycol.Canesten 1% cutaneous powder100 g of powder contain:active principleclotrimazole: 1 g.For the full list of excipients see section 6.1.

Excipients

Canesten 1% cream:sorbitan stearate; polysorbate 60; cetyl palmitate;cetostearyl alcohol;octyldodecanol;benzyl alcohol;purified water.Canesten 1% cutaneous spray, solution in multidose container with dosing pump:macrogol 400; isopropanol;propylene glycol. Canesten 1% cutaneous powder:rice starch.