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FOSAMAX Once Weekly Tablets (2018)

Active ingredients: Alendronic acid

Product Name and Form

FOSAMAX Once Weekly 70 mg tablets.

Pharmaceutical form

Tablet.

Oval white tablets, marked with an outline of a bone image on one side, and ‘31’ on the other.

Qualitative and Quantitative Composition

Each tablet contains 70 mg alendronic acid (as sodium trihydrate).

Excipients with known effect: Each tablet contains 113.4 mg lactose (as lactose anhydrous).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Alendronic acid

Alendronic acid is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with alendronic acid is of normal quality.

List of excipients

Microcrystalline cellulose
Lactose anhydrous
Croscarmellose sodium
Magnesium stearate

Pack sizes and Marketing

Aluminum/aluminum blisters in cartons containing 2, 4, 8, 12 or 40 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

10 November 2000/9 November 2005

Marketing authorization number:

PL 00025/0399