Canesten Antifungal Cream

1. Name Of The Medicinal Product

Canesten Antifungal Cream.

2. Qualitative And Quantitative Composition

Clotrimazole 1% w/w.

For excipients, see 6.1.

3. Pharmaceutical Form

Cream.

A white cream for cutaneous use.

4. Clinical Particulars

4.1 Therapeutic Indications

Clotrimazole is a broad-spectrum antifungal. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.

It is indicated 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.

4.2 Posology And Method Of Administration

Canesten Antifungal Cream should be applied thinly 2 or 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.

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

4.3 Contraindications

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

Hypersensitivity to cetostearyl alcohol.

4.4 Special Warnings And Precautions For Use

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

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

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: D01A C01

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity.

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.

5.2 Pharmacokinetic Properties

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.

5.3 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 SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzyl Alcohol

Cetostearyl Alcohol

Cetyl Palmitate

Octyldodecanol

Polysorbate 60

Sorbitan Stearate

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Aluminium tube with internal lacquer coating and HDPE screw-on cap.

Pack size: 20g.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

United Kingdom

Trading as Bayer plc, Consumer Care Division.

8. Marketing Authorisation Number(S)

PL 0010/0269

9. Date Of First Authorisation/Renewal Of The Authorisation

2^nd May 2001

10. Date Of Revision Of The Text

2 July 2010