CLASTEON Capsule Ref.[27810] Active ingredients: Clodronic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England

Product name and form

CLASTEON 400mg capsules.

Sodium Clodronate 400mg capsules.

Pharmaceutical Form

Hard capsules for oral administration.

The capsules are oblong, white and blue, marked “CLASTEON”.

Qualitative and quantitative composition

Each capsule contains 400mg sodium clodronate (as the tetrahydrate).

For excipients, see 6.1.

Active Ingredient 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

Capsule content: Maize starch, Talc, Magnesium stearate, Sodium starch glycolate.

Capsule shell: Titanium dioxide (E171), Indigotin (E132), Gelatin.

Pack sizes and marketing

PVC/PVDC/aluminium Blister Packs containing 30, 60 or 120 capsules.

Marketing authorization holder

Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England

Marketing authorization dates and numbers

PL 18157/0028

15 May 2007 / 13/09/2011

Drugs

Drug Countries
CLASTEON Canada, Israel, Italy, Malta, United Kingdom

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