SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Clotrimazole Cream 1%

Clotrimazole Athlete’s Foot Cream (when sold under GSL regulations).

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tube contains 1%w/w Clotrimazole.

Each 1 g of cream contains 10 mg of clotrimazole.

Excipient with known effect: cetostearyl alcohol.

For the full list of excipients, see section 6.1

3.    PHARMACEUTICAL FORM

Cream

A smooth white cream.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Clotrimazole is a broad-spectrum antifungal. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides.

For the treatment of:

(i)    All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species)

(ii)    All dermatomycoses due to yeasts ( Candida species). These include ringworm (tinea) infections (e.g. athlete’s foot), paronychia, pityriasis versicolor, erythrasma and intertrigo.

(iii)    Skin diseases showing secondary infection with these fungi.

(iv)    Candidal nappy rash, vulvitis and balanitis.

4.2.    Posology and method of administration

Posology

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

Method of administration

The cream should be applied thinly and evenly to the affected area 2 - 3 times daily and rubbed in gently.

If the feet are infected, they should be thoroughly washed and dried, especially between the toes, before applying the cream.

Treatment should be continued for at least one month for dermatophyte infections, or for at least two weeks for candidal infections.

4.3.    Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including cetostearyl alcohol.

Do not use the cream to treat nail or scalp infections.

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.    Interactions 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

In animal studies clotrimazole has not been associated with teratogenic effects but following oral administration of high doses to rats there was evidence of foetotoxicity.

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 has been used in pregnant patients for over a decade without attributable adverse effects.

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

Not relevant.

4.8.    Undesirable effects

As the listed undesirable effects are based on spontaneous reports, assigning an 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.

Local mild burning or irritation is experienced rarely by some patients after topical application. If this is intolerable treatment should be stopped. Hypersensitivity reactions may occur.

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 and 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 safety data of relevance to the prescribes which are additional to the information included in other sections of the SPC.

6.    PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

The cream contains benzyl alcohol, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, sorbitan monostearate and purified water.

6.2.    Incompatibilities

Not applicable

6.3.    Shelf Life

24 months

6.4.    Special precautions for storage

Store in a cool dry place.

6.5.    Nature and contents of container

Low density polyethylene (LDPE) or aluminium tube with cap.

Pack sizes: 20g, 50g.

6.6.    Special precautions for disposal

No special requirements.

7.    Marketing Authorisation Holder

Generics [UK] Limited t/a Mylan

Station Close

Potters Bar

Herts

EN6 1TL

8.    Marketing Authorisation Number

PL 04569/0194

9.    Date of First Authorisation/Renewal of the Authorisation

Date MA granted: Last renewal date:

10 DATE OF REVISION OF THE TEXT

29/05/2014