ROLPRYNA Prolonged-release tablet Ref.[49834] Active ingredients: Ropinirole

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Rolpryna SR 2 mg prolonged-release tablets.

Pharmaceutical Form
Prolonged-release tablet. Pink, biconvex, oval tablets (length: ca. 15.1 mm, width: ca. 8.1 mm, thickness: ca. 6.0 mm).

Qualitative and quantitative composition

Each prolonged-release tablet contains 2 mg ropinirole (as hydrochloride).

Excipient(s) with known effect: Each prolonged-release tablet contains 156.48 mg lactose.

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 core: Hypromellose type 2208 Lactose monohydrate Silica, colloidal anhydrous Carbomers 4,000-11,000 mPa.s Castor oil, hydrogenated Magnesium stearate Film-coating: Hypromellose type 2910 Titanium dioxide (E171) Macrogol 400 Iron oxide, red (E172) Iron oxide, yellow (E172) Iron oxide, black (E172)

Pack sizes and marketing

Tablets are available in cartons of 10, 21, 28, 30, 42, 60, 84 and 90 prolonged-release tablets in OPA/Alu/PVC//Alu blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/012/002

Date of first authorisation: 10^th June 2011
Date of last renewal: 14^th November 2015

Drugs

Drug	Countries
ROLPRYNA	Estonia, Spain, Hong Kong, Croatia, Ireland, Lithuania, Poland, Romania

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