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CANESTEN ANTIFUNGAL CREAM

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE / CLOTRIMAZOLE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Canesten Antifungal Cream
Canesten Fungal Infection 1% w/w Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w.
Excipient with known effect: cetostearyl alcohol
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Cream
A white cream for cutaneous use

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of:
(i)
(ii)
(iii)
(iv)

4.2

All dermatomycoses due to moulds and other fungi, (e.g. Trichophyton
species).
All dermatomycoses due to yeasts (Candida species).
Skin diseases showing secondary infection with these fungi.
Candidal nappy rash, vulvitis and balanitis.

Posology and method of administration
Canesten Antifungal Cream should be applied thinly 2 or 3 times daily and
rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about
the size of the hand. Treatment should be continued for at least one month for
dermatophyte infections and at least two weeks for candidal infections.
If the feet are infected they should be washed and dried, especially between the
toes, before applying the cream.

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

4.3

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

4.4

Special warnings and precautions for use
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g.
contact dermatitis).

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
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.
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:
Available pharmacodynamic/toxicological data in animals have shown excretion of
clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A
risk to the suckling child cannot be excluded. A decision must be made whether to
discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking
into account the benefit of breast-feeding for the child and the benefit of therapy for
the woman.

4.7

Effects on ability to drive and use machines

4.8

Clotrimazole cream has no or negligible influence on the ability to drive or use
machines.
Undesirable effects
As the listed undesirable effects are based on spontaneous reports, assigning
accurate frequency of occurrence for each is not possible.

Immune system disorders: allergic reaction (syncope, hypotension, dyspnea,
urticaria).
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema,
erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.
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.
4.9

Overdose
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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 grampositive 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 mcg/ml, suggesting that clotrimazole applied topically 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 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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Benzyl Alcohol
Cetostearyl Alcohol
Cetyl Palmitate
Octyldodecanol
Polysorbate 60
Sorbitan Stearate
Purified Water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 25oC.

6.5

Nature and contents of container
Aluminium tube with internal lacquer coating and HDPE screw-on cap.
Pack size: 20g.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom
Trading as Bayer plc, Consumer Care Division.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00010/0269

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
2 May 2001

10

DATE OF REVISION OF THE TEXT
03/03/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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