Fosamax (2011)
Active ingredients: Alendronic acid
Product Name and Form
FOSAMAX 10 mg Tablets.
Pharmaceutical form
Tablets.
Oval white tablets marked with ‘936’ on one side, and plain on the other.
Qualitative and Quantitative Composition
Each tablet contains 13.05 mg of alendronate sodium, which is the molar equivalent to 10 mg of alendronic acid.
Excipients:
Each tablet contains 103.95 mg lactose anhydrous.
For a full list of excipients see section 6.1
Chemical substance
Description
List of excipients
10 mg tablets:
Microcrystalline cellulose
Anhydrous lactose
Croscarmellose sodium
Magnesium stearate
Carnauba wax
Pack sizes and Marketing
Blisters of opaque white PVC lidded with aluminium foil.
Pack size: 28 tablets.
Marketing authorization holder
Authorization dates
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire
EN11 9BU
UK
10 mg tablets: 28 July 1995/ 3 June 2008
10 mg tablets: PL 0025/0326