Fosamax

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

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

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

Marketing authorization dates and numbers

10 mg tablets: PL 0025/0326

10 mg tablets: 28 July 1995/ 3 June 2008

Drugs

Drug
Countries
Austria, Brazil, Canada, Germany, Spain, France, Hong Kong, Ireland, Italy, Netherlands, Singapore, United Kingdom, United States