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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ecostatin Cream 1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Econazole nitrate 1.0% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream.
A smooth white to off-white aqueous cream, with a distinctly perfumed odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the topical treatment of fungal or yeast infections and certain skin infections caused by streptococci or
staphylococci. These include ringworm (Tinea) infections, athlete’s foot, paronychia, pityriasis versicolor, erythrasma,
intertrigo, fungal nappy rash, candidal vulvitis and candidal balanitis.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults and Children:
To be massaged gently into the affected and surrounding skin area morning and evening. It is particularly suitable for
moist or weeping lesions.
Infants and neonates:
No special dosage recommendations.
Elderly:
No specific dosage recommendations or precautions apply.
4.3 CONTRAINDICATIONS
Patients with a history of sensitivity to any of the components of the preparation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This preparation is not for oral use. It should not be used in or near the eyes. When Ecostatin Cream is being used on
the anogenital area, it is important to ensure the concurrent treatment of partners.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/06/2006_
_CRN 2024312_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
4.6 PREGNANCY AND LACTATION
There is no evidence of a teratogenic effect in animals. Systemic absorption is likely to be negligible. However, as
with other agents, use should be avoided during the first trimester o
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