Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Aristo Pharma GmbH, Wallenroder Straße 8–10, 13435 Berlin, Germany
Risedronate sodium 30 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White to off-white colored, circular shaped film coated biconvex tablets debossed with ‘L’ on one side and ‘30’ on the other side. |
Each film-coated tablet contains 30 mg risedronate sodium (as risedronate sodium hemipentahydrate), equivalent to 27.8 mg risedronic acid.
Excipients(s) with known effect: Each film-coated tablet contains 147.6 mg of lactose monohydrate.
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 Film coating: Hypromellose |
Nature of container: Clear PVC/PE/PVDC/aluminium foil blisters in a cardboard carton.
Blister pack of 14 tablets in a cardboard carton, tablet count 28 (2 × 14) and 14 (1 × 14)
Sample pack – 3 tablets in cardboard carton, tablet count 3 (1 × 3).
Not all pack sizes may be marketed.
Aristo Pharma GmbH, Wallenroder Straße 8–10, 13435 Berlin, Germany
PL 40546/0125
08/07/2011
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