ADARTREL Film-coated tablet

Product name and form

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.

Qualitative and quantitative composition

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.

List of Excipients

Tablet cores:

Lactose monohydrate
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate

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).

Pack sizes and marketing

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.

Marketing authorization holder

GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

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

Drugs

Drug
Countries
Germany, Spain, France, Netherlands, Poland, United Kingdom