AERODIOL Nasal Spray Solution 150 Micrograms/g
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
ESTRADIOL HEMIHYDRATE
Available from:
Les Laboratoires Servier
Dosage:
150 Micrograms/g
Pharmaceutical form:
Nasal Spray Solution
Authorization date:
2001-03-23
Summary of Product characteristics
License
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
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