Summary of medicine characteristics - GALPHARM ATHLETES FOOT 1% W/W CREAM
1 NAME OF THE MEDICINAL PRODUCT
Galpharm Athlete’s Foot 1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w
Excipient(s) with known effect:
Each 100 miligrams contains 1 mg benzyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of tinea pedis and tinea cruris.
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
A physician should be consulted if symptoms do not improve within 7 days.
Route of administration:
For Cutaneous use. Directly applied to the affected area.
4.3 Contraindications
Known hypersensitivity to any of the components.
Do not use the cream to treat nail and scalp infections.
4.4 Special warnings and precautions for use
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.
Excipient(s)
Cetyl alcohol and stearyl alcohol
The cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reaction (e.g. contact dermatitis).
Benzyl alcohol
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause mild local irritation.
4.5 Interaction with other medicinal products and other forms of interaction
None known
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.
Breast-feeding
It is unknown whether clotrimazole is excreted in breast milk, so it should be given with caution to lactating mothers.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseIn 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.
5.3 Preclinical safety data
5.3 Preclinical safety dataThere 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
No special precautions for storage
6.5 Nature and contents of container
6.5 Nature and contents of containerAluminium tube with polypropylene screw-on cap containing 20g of cream.
6.6 Special precautions for disposal
None