Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
ADARTREL 0.25, 0.5 or 2.0 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. 0.25 mg: White pentagonal-shaped, bevelled edge tablets, marked “SB” on one side and “4890” on the other. 0.5 mg: Yellow pentagonal-shaped, bevelled edge tablets, marked “SB” on one side and “4891” on the other. 2.0 mg: Pink pentagonal-shaped, bevelled edge tablets, marked “SB” on one side and “4893” on the other. |
Each film-coated tablet contains 0.25 / 0.5 / 2.0 mg of ropinirole (as hydrochloride).
Excipient with known effect:
Each tablet contains 45.3 / 45.0 / 44.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ropinirole |
Ropinirole is a non-ergoline D2/D3 dopamine agonist which stimulates striatal dopamine receptors. Ropinirole alleviates the dopamine deficiency which characterises Parkinson’s disease by stimulating striatal dopamine receptors. |
| List of Excipients |
|---|
|
Tablet cores: Lactose monohydrate Film coating: 0.25mg (white): Hypromellose, Macrogol 400, Titanium dioxide (E171), Polysorbate 80 (E433). 0.5mg (yellow): Hypromellose, Macrogol 400, Titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium lake (E132). 2.0 mg (pink): Hypromellose, Macrogol 400, Titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172). |
0.25 mg: PVC/PE/PVdC-Aluminium /paper child-resistant blister in cartons of 2 or 12 tablets.
0.5 mg: PVC/PE/PVdC-Aluminium/paper child-resistant blister in cartons of 28 or 84 tablets.
2.0 mg: PVC/PE/PVdC-Aluminium/paper child-resistant blister in cartons of 28 or 84 tablets.
Not all pack sizes may be marketed.
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Adartrel 0.25 mg film coated tablets: PL 19494/0033
Adartrel 0.5 mg film coated tablets: PL 19494/0034
Adartrel 2.0 mg film coated tablets: PL 19494/0036
10 May 2006 / 27 July 2009
| Drug | Countries | |
|---|---|---|
| ADARTREL | Germany, Spain, France, Netherlands, Poland, United Kingdom |
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