Clotrimazole 1% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lloydspharmacy Antifungal Skin Cream Clotrimazole 1% w/w Cream Boots Antifungal Cream Tesco Antifungal Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w
3 PHARMACEUTICAL FORM
Topical cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of skin infections due to dermatophytes (e.g. trycophyton species), yeasts (e.g. candida species), moulds and other fungi. These include ringworm (tinea) infections, paronychia, pityriasis versicolor, erythrasma and intertrigo, as well as fungal nappy rash, candidal vulvitis and candidal balanitis.
4.2 Posology and method of administration
Dosage:
Adult, children and elderly:
Apply to the affected area two or three times daily. Dermatophyte infections: treat for at least one month. Candida infections: treat for at least two weeks.
Route of administration:
Directly applied to the affected area.
4.3 Contraindications
Known hypersensitivity to any of the components
4.4 Special warnings and precautions for use
The cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermititis)
4.5 Interaction with other medicinal products and other forms of interaction
Clotrimazole Cream may cause damage to latex contraceptives. Consequentially patients should be advised to use alternative precautions for at least five days after using this product.
4.6 Pregnancy and lactation
Pregnancy
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 other 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
None known.
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 disorders: allergic reaction (syncope, hypotension, dyspnoea, urticaria).
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, 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
In the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of clotrimazole has been ingested within the preceding hour or 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 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.
Preclinical safety data
5.3
There are no preclinical data of reference to the prescriber which are additional to the information included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitan stearate Polysorbate 60 Cetyl Palmitate Stearyl Alcohol Cetyl Alcohol 2-Octyldodecanol Benzyl Alcohol Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None.
6.5
Nature and contents of container
Aluminium tube with polypropylene screw-on cap containing 20/30/50g of cream.
Special precautions for disposal
6.6
None.
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/1490
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27 January 1998
02/07/2015