Canesten Solution contains Clotrimazole 1.0% w/v.
Canesten Solution should be used to treat all fungal skin infections due to dermatophytes, yeasts, moulds and other fungi.
It is particularly suitable for use on hairy skin and in fungal infections of the outer ear (otitis externa) and middle ear (otomycoses).
Canesten Solution should be thinly and evenly applied to the affected area 2 or 3 times daily. To prevent relapse, treatment should be continued for at least two weeks after the disappearance of all signs of infection.
There is no separate dosage schedule for the elderly or the young.
There have been reports of a heat reaction when Canesten Solution is used concomitantly with Sofradex drops in the ear.
Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no relevant epidemiological data are available.
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible
Immune system disorder: allergic reaction (syncope, hypotension, dyspnea, urticaria)
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning
In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). It should be carried out only if the airway can be protected adequately.
Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 µg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.
Do not store above 25oC.
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