Summary of Product Characteristics (SmPC) - 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.
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
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 Interactions with other medicaments 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 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. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects.
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.
4.7 Effects on ability to drive and use machines
Clotrimazole cream has no or negligible influence on the ability to drive or use machines.
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)
Vascular disorders: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Skin and subcutaneous tissue disorders: blisters, dermatitis contact, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin
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
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.
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). Gastric lavage should be carried out only if the airway can be protected adequately.
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.
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 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.
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
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
Aluminium tube with polypropylene screw-on cap containing 20g of cream.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/1480
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/10/2005 / 13/05/2010
10 DATE OF REVISION OF THE TEXT
31/08/2023