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BONEFOS Film-coated tablets (2017)

Active ingredients: Clodronic acid

Product Name and Form

Bonefos 800 mg tablets.

Pharmaceutical form

Pale white, oval-shaped, film-coated tablets for oral use.

Qualitative and Quantitative Composition

Each tablet contains 1000 mg of disodium clodronate tetrahydrate, equivalent to 800 mg of anhydrous disodium clodronate.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Clodronic acid

Clodronic acid is a bisphosphonate, (formerly diphosphonates), a group of analogues of pyrophosphate, which have been shown, in vitro, to inhibit the formation and dissolution of calcium phosphate (hydroxyapatite). In vivo, they have been shown to inhibit bone resorption to a greater or lesser extent, depending on the compound, and clodronate is one of the most effective in this respect.

List of excipients

Croscarmellose sodium
Magnesium stearate
Silicified microcrystalline cellulose
Stearic acid

Coating:

Opadry II white, containing:

Macrogol (PEG) 3350
Polyvinyl alcohol (partially hydrolysed)
Purified water
Talc
Titanium dioxide (E171)

Pack sizes and Marketing

Bonefos tablets are supplied in clear, colourless PVC/aluminium blister packs of 10 and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

01 May 2008

Marketing authorization number:

PL 00010/0522