Repreve

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ropinirole hydrochloride 1.14mg equivalent to ropinirole 1 mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Ropinirole hydrochloride 1.14 mg (equivalent to ropinirole 1 mg)

Dosage:

1 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ropinirole hydrochloride 1.14mg equivalent to ropinirole 1 mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry green 03B21094

Units in package:

Blister pack, PVC/PCTFE/Al, PVC/PCTFE/PVC/AL, x 28 tablets (not marketed), 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

SmithKline Beecham (Cork) Ltd

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/Al, PVC/PCTFE/PVC/AL, x 28 tablets - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE/Al, PVC/PCTFE/PVC/AL,x 84 tablets - 84 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2003-08-20

Summary of Product characteristics

_THE MEDICINE IS NOT CURRENTLY MARKETED IN NEW ZEALAND_ 

1
DATA SHEET 
REPREVE
®

_ropinirole hydrochloride _

PRESENTATION 

REPREVE Tablets: Film coated, oval shaped tablets containing
ropinirole hydrochloride equivalent to 
0.25mg, 0.5mg, 1.0mg or 2.0mg ropinirole (as hydrochloride).  For
oral administration. 

The tablet strengths are distinguished by colour; 0.25mg (white),
0.5mg (yellow), 1.0mg (green) and 2.0mg 
(pink). 

REPREVE tablet cores contain lactose monohydrate, microcrystalline
cellulose, croscarmellose sodium 
and magnesium stearate as excipients.
 The film coat contains hydroxypropyl methylcellulose, polyethylene 
glycol and titanium dioxide.  The 0.25mg tablets also contain
polysorbate 80. 

Colouring agents are also contained in the film coating as follows: 
•  0.5mg tablets (yellow) contain iron oxide yellow, iron oxide
red, indigo carmine aluminium lake. 
•  1.0mg tablets (green) contain iron oxide yellow and indigo
carmine aluminium lake. 
•  2.0mg tablets (pink) contain iron oxide yellow and iron oxide
red. 

CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
REPREVE is indicated for the treatment of
idiopathic (primary) Restless Legs Syndrome (Ekbom’s 
Syndrome), including the reduction of associated periodic limb
movement and episodes of nocturnal 
arousal. 

_POSOLOGY AND METHOD OF ADMINISTRATION _
Individual dose titration against efficacy and tolerability is
recommended.  Ropinirole should be taken once-
daily before bed time, however the dose can be taken up to 3 hours
before retiring. 

Treatment Initiation (Week 1) 

The recommended initial dose is 0.25mg once daily for 2 days. If
this dose is well tolerated the dose may 
be increased to 0.5mg once daily for the remainder of Week 1. 

Therapeutic Regimen (Week 2 onwards) 

Following treatment initiation, the daily dose can be
increased according to the regimen below until optimal 
therapeutic response is achieved. 
_THE ME