RISEDRONATE SODIUM 5 mg Film-coated tablet Ref.[50628] Active ingredients: Risedronic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Product name and form

Risedronate sodium 5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow colored, circular shaped, beveled edge, film-coated biconvex tablets debossed with ‘X’ on one side and ‘61’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.6 mg risedronic acid).

Excipients with known effect: Each film-coated tablet contains lactose monohydrate 24.60 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Risedronic acid

Risedronic acid is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralisation is preserved.

List of Excipients

Tablet core:

Lactose monohydrate
Cellulose microcrystalline
Crospovidone
Hydroxy propyl cellulose
Magnesium stearate

Film coating:

Hypromellose
Titanium dioxide (E171)
Macrogol 400
Hydroxy propyl cellulose
Iron oxide yellow (E172)
Macrogol 8000
Silica colloidal anhydrous

Pack sizes and marketing

Transparent PVC / PE / PVdC / Aluminium blisters in a cardboard box, Packs 14, 20, 28, 84, 98 or 140 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0230

15/07/2011

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.