Canesten Dermatological Spray / Canesten AF Dual Action Spray

1. Name Of The Medicinal Product

Canesten Dermatological Spray (also available as Canesten AF Dual Action Spray).

2. Qualitative And Quantitative Composition

Clotrimazole 1% w/v.

For excipients, see 6.1.

3. Pharmaceutical Form

A colourless solution for topical administration by an atomiser.

4. Clinical Particulars

4.1 Therapeutic Indications

Legal Category P

Recommended 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.

Canesten Dermatological Spray is particularly suitable for infections covering large and/or hairy areas.

Legal Category GSL

For the treatment of tinea pedis (athlete's foot) and tinea cruris (jock itch).

4.2 Posology And Method Of Administration

The spray should be applied thinly 2-3 times daily for at least one month for dermatophyte infections, and at least two weeks for candidal and Pityriasis versicolor infections.

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

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.

Legal Category GSL Only

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

4.4 Special Warnings And Precautions For Use

Canesten Dermatological Spray should not be used near a naked flame, should not be allowed to come into contact with the eyes, ears or mucous membranes and should not be inhaled.

This product contains propylene glycol, which may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

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. 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.

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 SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl alcohol

Macrogol 400

Propylene glycol

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

No special storage requirements.

6.5 Nature And Contents Of Container

The solution is packaged in a white, high density polyethylene bottle and enclosed in a cardboard outer carton.

Canesten Dermatological Spray has an atomiser nozzle and lock cap. It is available in a 40ml pack size.

Canesten AF Dual Action Spray has an atomiser nozzle lock cap. It is available in a 25ml and 40ml pack size.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

Trading as: Bayer plc, Consumer Care Division

8. Marketing Authorisation Number(S)

PL 0010/0060R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 18 August 1988.

Date of last renewal of authorisation: 14 January 1999.

10. Date Of Revision Of The Text

2 July 2010

LEGAL CATEGORY

Canesten Dermatological Spray P

Canesten AF Dual Action Spray GSL