Ropaccord

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ropinirole hydrochloride 0.57mg equivalent to 0.5 mg ropinirole

Available from:

Accord Healthcare NZ Ltd

INN (International Name):

Ropinirole hydrochloride 0.57 mg (equivalent to 0.5 mg ropinirole)

Dosage:

0.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ropinirole hydrochloride 0.57mg equivalent to 0.5 mg ropinirole Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 03B82930

Units in package:

Blister pack, Alu-Alu pack of 7's, 42 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Urquima SA

Therapeutic indications:

Ropaccord Tablets is indicated for the treatment of Parkinson's disease.

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu-Alu pack of 7's - 42 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 84 tablets - 24 months from date of manufacture stored at or below 25°C. Store in a dry place, away from direct light 6 months opened stored at or below 25°C

Authorization date:

2009-11-03

Summary of Product characteristics

Ropinirole Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg and 5 mg Ver 2.0
-2013- Page 1 of 9
DATA SHEET
ROPACCORD
Ropinirole hydrochloride 0.25mg, 0.5mg, 1mg, 2mg and 5mg tablets
_ _
PRESENTATION
Ropaccord Tablets are presented as round, biconvex, film coated
tablets plain on
both sides containing ropinirole hydrochloride equivalent to 0.25,
0.5, 1.0, 2.0 or
5.0mg ropinirole (as hydrochloride).
Ropaccord tablets contain lactose, cellulose microcrystalline,
croscarmellose
sodium, magnesium stearate, hypromellose, macrogol as excipients. The
0.25mg
tablets also contain polysorbate. Colouring agents are also contained
in the film
coating as follows:

0.25mg tablets (White to off white) contains titanium dioxide.

0.5mg tablets (yellow) contains titanium dioxide, iron oxide yellow,
iron
oxide red, indigo carmine aluminium lake.

1.0mg tablets (green) contains titanium dioxide, iron oxide yellow,
indigo
carmine aluminium lake.

2.0mg tablets (pink) contains titanium dioxide, iron oxide yellow,
iron oxide
red.

5.0mg tablets (blue) contains titanium dioxide, indigo carmine
aluminium
lake.
Ropaccord Tablets are presented in Alu/Alu blister pack and HDPE
bottle.
CLINICAL PARTICULARS
_THERAPEUTIC INDICATIONS _
Ropaccord Tablets is indicated for the treatment of Parkinson's
disease.
Ropinirole
is
effective
as
early
therapy
in
patients
requiring
dopaminergic
therapy.
In a comparative study, ropinirole was superior to bromocriptine. When
these two
drugs were administered concomitantly with selegiline there was no
difference
between them.
Ropinirole Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg and 5 mg Ver 2.0
-2013- Page 2 of 9
Ropaccord Tablets delays the need for initiation of _L_-dopa therapy.
As adjunctive treatment of _L_-dopa, Ropaccord Tablets enhances the
efficacy of
_L_-dopa,
including
control
of
"on-off"
fluctuations
and
"end
of
dose"
effects
associated with chronic _ L_-dopa therapy and permits reduction in
daily _ L_-dopa
dose.
_POSOLOGY AND METHOD OF ADMINISTRATION _
Individual dose titration against efficacy and to