Canesten Cream (also available as Canesten AF Dual Action Cream)

Clotrimazole 1% w/w.

For excipients, see 6.1.

A white cream for topical use.

Legal Category P

For the treatment of:

(i) All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species).

(ii) All dermatomycoses due to yeasts (Candida species).

(iii) Skin diseases showing secondary infection with these fungi.

(iv) Candidal nappy rash, vulvitis and balanitis.

Legal Category GSL

For the treatment of tinea pedis and tinea cruris.

There is no separate dosage schedule for the young or elderly.

Legal Category P Only

Canesten Cream should be applied thinly 2-3 times daily and rubbed in gently. Treatment should be continued for at least one month for dermatophyte infections and at least two weeks for candidal infections.

If the feet are infected they should be washed and dried, especially between the toes, before applying the cream.

Legal Category GSL Only

Canesten Cream should be applied thinly 2-3 times daily and rubbed in gently. If the feet are infected they should be washed and dried, especially between the toes, before applying the cream. A physician should be consulted if symptoms do not improve within 7 days.

Hypersensitivity to clotrimazole or any of the excipients in this product.

Hypersensitivity to cetostearyl alcohol.

Legal Category GSL Only

Do not use the cream to treat nail or scalp infections.

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Legal Category P Only

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.

Legal Category GSL Only

No interactions.

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 other relevant epidemiological data available.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

Not applicable.

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, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or 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.

ATC Code: D01A C01

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.

Mechanism of Action

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Pharmacodynamic Effects

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.

Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

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 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.

There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Octyldodecanol

Benzyl Alcohol

Purified water

Not applicable.

36 months.

Do not store above 25^oC.

The cream is filled into aluminium tubes with internal lacquer coating and HDPE screw-on caps and enclosed in an outer carton. Pack sizes available are 15g, 25g and 30g (Canesten AF Dual Action Cream), 20g and 50g.

No special requirements.

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

Trading as Bayer plc, Consumer Care Division

PL 0010/0016R

2 July 2010