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 a day and gently rubbed in. A few drops are enough to treat an area of about the size of the hand. 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

Propylene glycol may cause skin irritations.
Keep out of the sight and reach of children. Avoid contact with the eyes. Do not swallow.

None known.

Pregnancy
To date only limited data are available on the use of clotrimazole during pregnancy. Animal studies have shown no evidence of direct or indirect deleterious effects with regard to reproductive toxicity (see section 5.3). As a precautionary measure, the use of clotrimazole should be avoided during the first trimester of pregnancy.

Lactation
It is not known whether clotrimazole passes into breast milk in humans. The available pharmacodynamic / toxicological data from animal studies show that clotrimazole / metabolites pass into breast milk following oral administration (see section 5.3 for details). Because of the low absorption rate following topical use, Canesten Solution can be used as directed during lactation.

To prevent direct exposure of the infant to Canesten Solution, breast-feeding mothers should avoid using Canesten Solution throughout the entire lactation period.

Fertility
No studies on the influence of clotrimazole on fertility in humans are available. Animal studies have shown no effect of the substance on fertility.

Canesten Solution has no influence on the ability to drive and operate machines.

The frequency information on adverse effects is based on the following categories:

The following adverse effects associated with the use of clotrimazole were identified after marketing authorisation was granted. Because these reactions were voluntarily reported by patient groups of unknown size, it is not possible to estimate the frequency on the basis of the available data.

Immune system disorders (frequency unknown):
Allergic reactions (urticaria, hypotension, dyspnoea, syncope)

Skin and subcutaneous tissue disorder (frequency unknown): Prickling/burning sensation, redness, pruritus, skin irritation, rash, blisters, oedema, skin peeling/scaling, pain
Because of the content of propylene glycol, the product should not be applied to mucous membranes, as it could cause local irritation. Drying of the skin may occur during use.

Reporting suspected undesirable effects

Reporting of suspected undesirable effects after marketing authorisation is granted is extremely important. It enables continuous monitoring of the risk-benefit ratio of a medicinal product.

To report any side effect(s):

National Pharmacovigilance and Drug Safety Center (NPC).

Fax: + 966 - 11 - 205 - 7662.

Call NPC at +966 - 11 - 2038222,

Ext.: 2317 - 2356 - 2353 - 2354 - 2334 - 2340. Toll - free: 8002490000.

E - mail: npc.drug@sfda.gov.sa. Website: www.sfda.gov.sa/npc

No acute risk of intoxication is thought to exist, since intoxication is unlikely after a single application of an overdose to the skin (use on a large surface area under conditions that favour absorption) or inadvertent ingestion. There is no specific antidote.

Pharmacotherapeutic group:
imidazole and triazole derivatives, topical antimycotic.
ATC code: D01AC01

Mechanism of action
Clotrimazole, the active substance in Canesten Solution, acts as an inhibitor of ergosterol production in fungi, the inhibition of which results in disruption of the synthesis and function of the cytoplasm membrane.
Clotrimazole has a broad antimycotic spectrum of activity in vitro and in vivo that includes dermatophytes, yeast-like fungi, moulds and dimorphous fungi.
Under suitable test conditions the MIC values for these fungal species is in the order of less than 0.062–8.0 µg/mL substrate. Clotrimazole acts primarily as a fungistatic or fungicide (depending on its concentration at the infection site). Its in vitro action is limited to proliferating fungal elements; fungal spores are poorly susceptible.
In addition to its antimycotic activity, clotrimazole is also active against Gram-positive (streptococci / staphylococci / Gardnerella vaginalis) and Gram-negative (Bacteroides) microorganisms.
Clotrimazole inhibits the proliferation of corynebacteria and Gram-positive cocci – except enterococci – in vitro at concentrations of 0.5–10 µg/mL substrate.

The resistance situation of clotrimazole is favourable: primarily resistant variants of sensitive fungal species are very rare, and secondary resistance development of sensitive fungi has been observed under therapeutic conditions only in isolated cases.

Pharmacokinetic studies after dermal application have shown that clotrimazole is absorbed through intact or inflamed skin into the bloodstream in humans to a minimal extent. The resulting peak plasma concentrations of clotrimazole were below the detection threshold of 0.001 µg/mL. The topical use of clotrimazole on the skin is therefore unlikely to have appreciable systemic or adverse effects.

Non-clinical data have shown no specific risks for humans based on conventional studies of safety, multiple-dose toxicity, reproductive and developmental toxicity, genotoxicity, and carcinogenicity.
Local and systemic tolerance was investigated in studies involving the subacute dermal administration of various clotrimazole doses to rabbits. No evidence of treatment-related local or systemic adverse effects was found in any of these studies.
The oral toxicity of clotrimazole was extensively investigated.
Clotrimazole was found to be mildly to moderately toxic in animal experiments after a single oral dose with LD50 values of 761 to 923 mg/kg body weight  in mice, 95 to 114 mg/kg body weight in newborn rats, 114 to 718 mg/kg body weight in adult rats, > 1,000 mg/kg body weight in rabbits and > 2,000 mg/kg body weight in dogs and cats.
Studies in which multiple oral doses were given to rats and dogs showed the liver to be the primary target organ for toxic effects. Elevated serum transaminase concentrations and vacuole formation and fat deposits in the liver occurred in a study on chronic use (78 weeks) in rats starting at a dose of 50 mg/kg and a study on subchronic use (13 weeks) in dogs from a dose of 100 mg/kg.
Clotrimazole was extensively investigated in in vitro and in vivo mutagenicity tests. No evidence of mutagenicity was found. No carcinogenic effect was observed in a 78-week study in which clotrimazole was administered to rats.

In a fertility study in rats, groups of FB30 rats received oral clotrimazole doses of up to 50 mg/kg body weight for ten weeks both before and during a three-week mating period (only in the males) or up to day 13 of gestation or four weeks postpartum (in the females). A reduced survival rate of the offspring was found in the group given 50 mg/kg body weight. Clotrimazole had no adverse effect on the development of the offspring in doses of up to 25 mg/kg body weight and no effect on fertility in any of the doses tested.

No teratogenic effects were observed in studies on mice, rabbits and rats who received oral doses of up to 200, 180 and 100 mg/kg, respectively.
One study in which three suckling rats received 30 mg/kg clotrimazole intravenously showed that the substance was secreted in the milk in a concentration that exceeded the plasma concentration by a factor of 10 to 20. The milk concentration then fell to a factor of 0.4 within 24 hours.
In view of the limited systemic absorption of the substance after topical application, no risks are likely to be associated with the topical use of clotrimazole.

Propylene glycol, 2-propanol, Macrogol 400.

Not applicable.

Do not store above 30⁰C

Bottle containing 20 mL solution.

Do not dispose of the product down the drain (in the toilet or sink). Medicine that is no longer required can be disposed of in the household waste. These measures will help to protect the environment.