ECOSTATIN Pessary 150 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
ECONAZOLE NITRATE
Available from:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dosage:
150 Milligram
Pharmaceutical form:
Pessary
Authorization date:
1978-01-30
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Ecostatin Pessaries 150 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains Econazole nitrate 150 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Pessary
Cream-white to yellowish opaque, oval pessary with a fat-like odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Vulvovaginal candidosis.
4.2 Posology and method of adminstration
Adults:
One pessary to be inserted at bedtime for three consecutive nights. Administration should be continued even if
menstruation occurs, and despite the disappearance of signs and symptoms of the infection.
The pessary should be inserted high into the vagina while the patient is supine.
Although a three-day course of therapy usually suffices, it may be necessary to institute a second course of therapy.
Children and infants:
Vulvo-vaginal candidosis is not normally a problem in children, therefore there are no specific dosage
recommendation.
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.
Irish Medicines Board
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