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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
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

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

Marketing authorization number:

10 mg tablets: PL 0025/0326