Canesten

Canesten Dermatological Spray

Clotrimazole 1% w/v.

Excipient with known effect: propylene glycol 546mg in each 1ml of spray.

For the full list of excipients, see section 6.1.

A colourless solution for topical administration by an atomiser.

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.

The spray is particularly suitable for infections covering large and/or hairy areas.

Posology

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.

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

Method of administration

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

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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.

Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.

Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

None known.

Pregnancy:

There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

Lactation:

There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation. If used topically on the nipple area, wash breasts before feeding child.

Fertility:

No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.

Clotrimazole spray has no or negligible influence on the ability to drive or use machines.

As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.

Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.

Vascular disorders: syncope, hypotension.

Respiratory, thoracic and mediastinal disorders: dyspnoea.

Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.

General disorders and administration site conditions: application site irritation, application site reaction, oedema, pain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.

However, 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). Gastric lavage should be carried out only if the airway can be protected adequately.

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivatives

ATC Code: D01A C01

Mechanism of Action

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

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

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate. The mode of action of clotrimazole is primarily 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.

In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides).

In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 µg/ml substrate.

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

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity.

Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased pup survival.

In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs.

Isopropyl alcohol

Macrogol 400

Propylene glycol

Not applicable.

24 months.

No special storage requirements.

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.

No special requirements.

Bayer plc

400 South Oak Way

Reading

RG2 6AD

PL 00010/0060R

Date of first authorisation: 18 August 1988.

Date of last renewal of authorisation: 14 January 1999.

07/06/2022