Summary of Product Characteristics last updated on medicines.ie: 9/4/2015
Contains clotrimazole 1% w/w (equivalent to 10mg/g).
Excipients: contains 10% w/w cetostearyl alcohol.
For a full list of excipients, see section 6.1.
A white oil-in-water type cream.
4.1 Therapeutic indications
A broad spectrum antifungal for use in the topical treatment of infections due to superficial dermatophytes, Candida species and other fungi sensitive to the anti-infective: Staphylococcus and Bacteroides. The drug has no effect on Lactobacilli.
4.2 Posology and method of administration
Canesten Cream should be 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.
Patients should notify their physician if there is no improvement after 4 weeks of treatment.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
All possibly infected areas should be treated at the same time.
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Avoid contact with eyes and do not swallow.
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 Fertility, pregnancy and lactation
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.
There are limited amount of data from the use of clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of clotrimazole during the first trimester of pregnancy.
Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk (see section 5.3). Breast-feeding should be discontinued during treatment with clotrimazole.
4.7 Effects on ability to drive and use machines
The medication has no or negligible influence on the ability to drive or use machinery.
4.8 Undesirable effects
The following adverse reactions have been identified during post-approval use of Clotrimazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Immune system disorders
Allergic reaction (ME) (with symptoms such as urticaria (ME), dyspnoe (PT), hypotension (PT) and syncope (PT)).
Skin and subcuteaneous tissue disorders
Pruritus (ME), rash (ME), blisters (PT), peeling/exfoliation (PT), discomfort/pain (PT), stinging/burning (PT), edema (PT), burning (PT), irritation, erythema (PT).
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: email@example.com.
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).
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivates.
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 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 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 vagiinalis) and gram-negative microorganisms (Bacteroides). It has no effect on Lactobacilli.
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.
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 on the skin is unlikely to lead to measurable systemic effects or side effects.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
6.1 List of excipients
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25° C.
6.5 Nature and contents of container
Aluminium tubes with internal lacquer coating and HDPE screw-on caps containing a smooth white oil-in-water type cream supplied in 20g and 50g presentations.
6.6 Special precautions for disposal and other handling
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how dispose of medicines no longer required. These measures will help to protect the environment.
Date of the first authorisation:
01 April 1977
Date of last renewal:
01 April 2007