This information is intended for use by health professionals

1. Name of the medicinal product

Canesten Dermatological Powder

(also available as Canesten AF Dual Action Powder)

2. Qualitative and quantitative composition

Clotrimazole 1% w/w.

For excipients, see 6.1.

3. Pharmaceutical form

Powder for topical application.

4. Clinical particulars
4.1 Therapeutic indications

Legal Category P

Canesten Dermatological Powder should be used externally as an adjunct to treatment with Canesten Cream, Solution or Dermatological Spray and as a prophylactic against reinfection, particularly in infections involving skin folds, and where perspiration is a problem.

Legal Category GSL

Should be used as an adjunct to treatment with Canesten AF Dual Action Cream or Canesten AF Dual Action Spray and as a prophylactic against reinfection of tinea pedis (athlete's foot) only.

4.2 Posology and method of administration

Canesten Dermatological Powder should be sprinkled onto the affected areas two to three times daily after using Canesten Cream, Solution or Dermatological Spray. The powder may also be dusted inside articles of clothing and footwear which are in contact with the infected area.

4.3 Contraindications

Hypersensitivity to clotrimazole or the excipient rice starch.

Legal Category GSL Only

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

4.4 Special warnings and precautions for use

None.

4.5 Interaction with other medicinal products and other forms of interaction

None.

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

Rarely patients may experience local mild burning or irritation immediately after applying the powder. Very rarely the patient may find this irritation intolerable and stop treatment.

Other undesirable effects:

Body as a whole:

allergic reaction, pain

Skin and appendages:

pruritis, rash

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 practically not 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, reflecting that clotrimazole applied topically does not lead to measurable systemic effects or side effects.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical particulars
6.1 List of excipients

Rice starch

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

60 months.

6.4 Special precautions for storage

No special storage requirements.

6.5 Nature and contents of container

Polyethylene powder canister with a perforated conical plug for dusting and a screw cap. The canister contains 30g of powder.

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 0010/0067

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation:

27 July 1978

Date of last renewal:

8 January 1999

10. Date of revision of the text

April 2006

Legal category

Canesten Dermatological Powder

P

Canesten AF Dual Action Powder

GSL