Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Takeda UK Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom
Fosrenol 500 mg chewable tablets.
Fosrenol 750 mg chewable tablets.
Fosrenol 1000 mg chewable tablets.
| Pharmaceutical Form |
|---|
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Chewable tablet. Fosrenol 500 mg chewable tablets: White, round, 18mm, bevelled-edge flat tablets debossed with ‘S405/500’ on one side. Fosrenol 750 mg chewable tablets: White, round, 20mm, bevelled-edge flat tablets debossed with ‘S405/750’ on one side. Fosrenol 1000 mg chewable tablets: White, round, 22mm, bevelled-edge flat tablets debossed with ‘S405/1000’ on one side. |
Fosrenol 500 mg chewable tablets: Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg lanthanum.
Fosrenol 750 mg chewable tablets: Each chewable tablet contains lanthanum carbonate hydrate corresponding to 750 mg lanthanum.
Fosrenol 1000 mg chewable tablets: Each chewable tablet contains lanthanum carbonate hydrate corresponding to 750 mg lanthanum.
Excipient(s) with known effect:
Fosrenol 500 mg chewable tablets: Chewable tablets also contain on average 1066 mg of dextrates, containing glucose.
Fosrenol 750 mg chewable tablets: Chewable tablets also contain on average 1599 mg of dextrates, containing glucose.
Fosrenol 1000 mg chewable tablets: Chewable tablets also contain on average 2132 mg of dextrates, containing glucose
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lanthanum |
Lanthanum is indicated as a phosphate binding agent for use in the control of hyperphosphataemia. |
| List of Excipients |
|---|
|
Dextrates (hydrated) |
White cylindrical HDPE bottles containing a rayon coil fitted with a tamper evident, child resistant polypropylene screw cap.
Pack sizes:
Fosrenol 500 mg chewable tablets: 20, 45 tablets. Multipack containing 90 (2 packs of 45) chewable tablets.
Fosrenol 750 mg chewable tablets: 15, 45 tablets. Multipack containing 90 (6 packs of 15) chewable tablets.
Fosrenol 1000 mg chewable tablets: 10, 15 tablets. Multipack containing 90 (6 packs of 15) chewable tablets.
Not all pack sizes may be marketed.
Takeda UK Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom
Fosrenol 500 mg chewable tablets: PL 16189/0139
Fosrenol 750 mg chewable tablets: PL 16189/0140
Fosrenol 1000 mg chewable tablets: PL 16189/0138
Date of first authorisation: 12 September 2006
Date of latest renewal: 19 March 2014
| Drug | Countries | |
|---|---|---|
| FOSRENOL | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa |
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