Canesten Solution

1. Name Of The Medicinal Product

Canesten Solution

2. Qualitative And Quantitative Composition

Clotrimazole 1.0% w/v.

For excipients, see 6.1.

3. Pharmaceutical Form

A clear solution.

4. Clinical Particulars

4.1 Therapeutic Indications

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).

4.2 Posology And Method Of Administration

Canesten Solution should be thinly and evenly applied to the affected area 2 or 3 times daily. 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.

4.3 Contraindications

Hypersensitivity to clotrimazole or macrogol 400.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports of a heat reaction when Canesten Solution is used concomitantly with Sofradex drops in the ear.

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 SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 400.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

HDPE bottles with dropper insert and screw-on cap.

Pack size: 20 ml

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 0010/0082

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of the first authorisation:	12 June 1981
Date of last renewal of authorisation:	28 May 2002

10. Date Of Revision Of The Text

2 July 2010

Legal Category

P