SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Galpharm Athlete’s Foot 1% w/w Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Clotrimazole 1% w/w

For excipients see 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

The cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reaction (e.g. contact dermatitis)

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

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.

5.3 Preclinical safety data

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

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 Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG

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

04/05/2011