Source: Marketing Authorisation Holder Revision Year: 2018 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Actonel 5 mg film coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Oval yellow film-coated tablet with RSN on one side and 5 mg on the other. |
Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid).
Excipient with known effect: Each film-coated tablet contains lactose.
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: Iron oxide yellow El72 |
Opaque PVC/aluminium foil blister cards of 14 tablets in a cardboard carton, tablet count 14, 28 (2 × 14), 84 (6 × 14), 98 (7 × 14) or 10 × 14 (hospital bundle).
2 x I0 count perforated blister strip (hospital unit dose).
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PA 1390/193/001
Date of first authorisation: 20th March 2000
Date of last renewal: 13th August 2009
| Drug | Countries | |
|---|---|---|
| ACTONEL | Austria, Australia, Brazil, Canada, Cyprus, Germany, Spain, France, Hong Kong, Croatia, Ireland, Italy, Japan, Netherlands, New Zealand, Romania, Singapore, United Kingdom, United States, South Africa |
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