TINADERM PLUS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TOLNAFTATE

Available from:

Schering-Plough Limited

Dosage:

0.09 %w/w

Pharmaceutical form:

Cutaneous Spray Powder

Authorization date:

1992-04-22

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tinaderm Plus Powder Aerosol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 0.09% w/w
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray suspension.
A white to pale yellow suspension with a faint herbal odour.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Tinaderm Plus Powder Aerosol is recommended
for use as a fungicide in the topical treatment and
prophylaxis of 
infections due to dermatophytes sensitive to
this agent including Microspora, Epidermophyta and Trichophyta.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Tinaderm Plus Powder Aerosol should be sprayed to
cover the affected areas twice daily after thoroughly washing 
and drying the areas concerned. Spray into shoes and
socks or stockings which may act as reservoirs of infection.
Dosage is similar in all groups.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tinaderm Plus Powder Aerosol is for external use only.
In mixed infections supplementary anti-infective therapy
is indicated. If there is no response after 4 weeks, 
reassessment of diagnosis should be made.
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.
IRISH MEDICINES BOARD
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_Date Printed 12/01/2006_
_CRN 2018586_
_page number: 1_
Compared with control groups, no
significant teratogenic effects were seen in rabbits, guinea-pig