Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
Les Laboratoires Servier
ESTRADIOL HEMIHYDRATE
150 Micrograms/g
Nasal Spray Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-05-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AERODIOL 150 micrograms/dose, nasal spray solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each spray delivers 0.07 ml of solution which contains estradiol equivalent to 150 micrograms of estradiol hemihydrate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in post menopausal women. The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NASAL ROUTE. The recommended dose for initiation of treatment is 150 micrograms (1 spray) in a nostril. After 2 or 3 cycles the dosage may be adjusted in response to clinical symptoms: The usual maintenance dose is 300 micrograms (2 sprays) per 24 hours, i.e. 1 spray in each nostril once daily. If symptoms of oestrogen deficiency persist, the number of sprays may be increased up to 3 or 4 per day (450 micrograms or 600 micrograms), in divided doses, morning and evening. In the event of signs of hyperoestrogenism such as breast tenderness, abdominal bloating, anxiety, nervousness or aggressiveness, the dosage should be reduced to 1 spray (150micrograms) daily. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 "Special warnings and special precautions for use") should be used. AERODIOL may be administered as cyclic or continuous treatment: Cyclic treatment: AERODIOL is used cyclically for a duration of 21 to 28 days, followed by a 2- to 7-day treatment-free period. Continuous treatment: AERODIOL is administered daily without a break in treatment. Continuous (non-cyclic) treatment may Read the complete document