STEOVESS ONCE WEEKLY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
SODIUM ALENDRONATE TRIHYDRATE (MICRONISED)
Available from:
Nycomed GmbH
Dosage:
70 Base Milligrams
Pharmaceutical form:
Tablets Effervescent
Authorization date:
2012-03-02
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Steovess Once Weekly 70 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate.
Excipients: each effervescent tablet contains 602.54 mg of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
White to off-white round effervescent tablets of 25 mm diameter, flat faced with bevelled edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. Steovess 70 mg reduces the risk of vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 70 mg effervescent tablet once weekly.
Patients should be instructed that if they miss a dose of Steovess 70 mg, they should take one effervescent tablet on the
morning after they remember.
They should not take two effervescent tablets on the same day but should return to taking one effervescent tablet once a
week, as originally scheduled on their chosen day.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued
treatment should be re-evaluated periodically based on the benefits and potential risks of Steovess on an individual
patient basis, particularly after 5 or more years of use.
Method of administration
_To permit adequate absorption of alendronate:_
Steovess 70 mg must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with
plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the
absorption of alendronate (see section 4.5).
_To facilitate delivery to the stomach and t
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