FOSAMAX ONCE WEEKLY 70 MG TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
ALENDRONATE SODIUM
Available from:
Merck Sharp and Dohme Limited
Dosage:
70 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2001-05-17
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Fosamax Once Weekly 70 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the equivalent of 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate.
Excipients:
Each tablet contains 113.4 mg lactose anhydrous.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oval white tablets, marked with an outline of a bone image on one side, and ‘31’ on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of postmenopausal osteoporosis. ‘Fosamax’ reduces the risk of vertebral and hip fractures.
4.2 Posology and method of administration
The recommended dosage is one 70 mg tablet once weekly. 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 ‘Fosamax’ on an individual patient basis, particularly after 5 or more years of use.
To permit adequate absorption of alendronate:
‘Fosamax’ must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain
water only. Other&
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