SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Tinaderm Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Tolnaftate 1.0% w/w

3 PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Tinaderm is recommended in the topical treatment of Tinea pedia, Tinea crurus, Tinea corporis, Tinea manuum, due to infection with Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum audouinii, Epidermophyton fluccusum, and for Tinea versicolor due to Malassezia furfur.

4.2 Posology and method of administration

The cream should be applied topically to the affected area twice a day. When treating Athlete’s Foot, the feet should be thoroughly washed and dried before applying the cream.

Symptomatic relief is usually rapid, often within 2-3 days and lesions generally clear within two or three weeks but may take longer when palmar or plantar sites are involved. Removal of hardened skin for calluses from these areas if helpful.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Tinaderm Cream is for external use only, Keep out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

None Known.

4.6 Pregnancy and lactation

There is no evidence of safety of the drug in human pregnancy or during lactation, but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed during pregnancy, this drug can be used if there is no safer alternative.

Compared with control groups, no significant teratogenic effects were seen in rabbits, guinea-pigs, mice and rats following oral, topical or subcutaneous administration of tolnaftate.

4.7 Effects on ability to drive and use machines

Not applicable.

Undesirable effects

Skin reactions occur rarely with tolnaftate and include irritation and contact dermatitis. If this occurs treatment should be stopped and referral made to a

GP

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Tolnaftate is a highly effective fungicidal agent against cutaneous fungal infections.

Pharmacokinetic properties

As tolnaftate is applied topically, these data are not applicable.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Chlorocresol; sodium acid phosphate; white soft paraffin; cetomacrogol 1000; cetostearyl alcohol; mineral oil; butylated hydroxytoluene and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store in a cool place.

6.5 Nature and contents of container

15g or 18.75g epoxy lined aluminium tubes with polyethylene caps.

Optionally the 15g tube may be enclosed with a 50g pack of Tinaderm Powder (PL 0201/0078) or Tinaderm Plus Powder (PL 0201/0113) in an outer card carton.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire,

EN11 9BU, UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00025/0591

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2^nd November 1987 / 01^st October 2003

10 DATE OF REVISION OF THE TEXT

12/01/2011