Apo-Ropinirole

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ropinirole hydrochloride 1.14mg equivalent to to 1 mg ropinirole

Available from:

Apotex NZ Ltd

INN (International Name):

Ropinirole hydrochloride 1.14 mg (= to 1 mg ropinirole)

Dosage:

1 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ropinirole hydrochloride 1.14mg equivalent to to 1 mg ropinirole Excipient: Citric acid Hyprolose Hypromellose Indigo carmine aluminium lake Iron oxide yellow Lactose Macrogol 8000 Magnesium stearate Titanium dioxide

Units in package:

Blister pack, Al foil/ Al foil laminate, 84 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Ind-Swift Laboratories Limited

Therapeutic indications:

Ropinirole 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 delays the need for initiation of L-dopa therapy. As adjunctive treatment of L-dopa, ropinirole 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.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al foil/ Al foil laminate - 84 tablets - 24 months unopened stored at or below 25°C protect from light and moisture - Blister pack, Al foil/ Al foil laminate - 100 tablets - 24 months unopened stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE bottle with blue HDPE cap and silica/activated carbon desiccant - 84 tablets - 24 months unopened stored at or below 25°C protect from light and moisture 84 days opened stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE bottle with blue HDPE cap and silica/activated carbon desiccant - 100 tablets - 24 months unopened stored at or below 25°C protect from light and moisture 84 days opened stored at or below 25°C protect from light and moisture

Authorization date:

2009-11-27

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-ROPINIROLE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 7
1. PRODUCT NAME
APO-ROPINIROLE 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg and 5mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ropinirole hydrochloride 0.25mg
Ropinirole hydrochloride 0.5mg
Ropinirole hydrochloride 1mg
Ropinirole hydrochloride 2mg
Ropinirole hydrochloride 3mg
Ropinirole hydrochloride 4mg
Ropinirole hydrochloride 5mg
EXCIPIENT(S) WITH KNOWN EFFECT
Contains lactose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APO-ROPINIROLE is available as oral, film coated tablets in the
following strengths:
APO-ROPINIROLE 0.25mg tablets are white, pentagonal, biconvex
film-coated tablet identified by an
engraved “ROP” over “.25” on one side and “APO’ on the
other side. Each tablet typically weighs about
153mg.
APO-ROPINIROLE 0.5mg tablets are yellow, pentagonal, biconvex
film-coated tablet identified by an
engraved “ROP” over “.5” on one side and “APO’ on the
other side. Each tablet typically weighs about
153mg.
APO-ROPINIROLE 1mg tablets are green, pentagonal, biconvex film-coated
tablet identified by an
engraved “ROP” over “1” on one side and “APO’ on the other
side. Each tablet typically weighs about
153mg.
APO-ROPINIROLE 2mg tablets are pink, pentagonal, biconvex film-coated
tablet identified by an
engraved “ROP” over “2” on one side and “APO’ on the other
side. Each tablet typically weighs about
153mg.
APO-ROPINIROLE 3mg tablets are purple, pentagonal, biconvex
film-coated tablet identified by an
engraved “ROP” over “3” on one side and “APO’ on the other
side. Each tablet typically weighs about
153mg.
APO-ROPINIROLE 4mg tablets are pale brown, pentagonal, biconvex
film-coated tablet identified by
an engraved “ROP” over “4” on one side and “APO’ on the
other side. Each tablet typically weighs about
153mg.
APO-ROPINIROLE 5mg tablets are blue, pentagonal, biconvex film-coated
tablet