Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Teva Pharma B.V., Swansweg 5, 2031GA Haarlem, Netherlands
Risonate Once Weekly 35 mg Film-coated Tablets.
| Pharmaceutical Form |
|---|
|
Film-coated Tablet. Orange, round, Film-coated Tablet, debossed with "R35"on one side and plain on the other. |
Each Film-coated Tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid).
Excipients with known effect: Each Film-coated Tablet contains 140 mg 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 Coating: Polyvinyl alcohol |
Transparent PVC/PVdC – Aluminium blisters in a cardboard carton.
Blisters in packs containing 1, 2, 4, 8, 10, 12, 12 (3x4), 14, 16, 16 (4x4) or 30 tablets.
Hospital packs 4 (4x1), 10 (10 × 1) or 50 tablets (50 × 1).
Not all pack sizes may be marketed.
Teva Pharma B.V., Swansweg 5, 2031GA Haarlem, Netherlands
PA0749/064/001
Date of first authorisation: 12th December 2008
Date of last renewal: 1st December 2012
| Drug | Countries | |
|---|---|---|
| RISONATE | Ireland, Lithuania |
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