Medicinal product name Oprymea
Pharmaceutical form Prolonged-release tablet
Strength 3.15 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code N04BC05 Anti-parkinson drugs

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANTI-PARKINSON DRUGS"
SubstanceClassComment
PramipexolumCSuitable for older persons, with specific cautions. Sedative. Start therapy under specialist supervision. Reduce the dose in even moderate renal insufficiency. The most common adverse effects are orthostatic hypotension, gastrointestinal symptoms, drowsiness, hallucinations, confusion and sudden bouts of falling asleep. Take interactions into account, especially with antipsychotics.

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N90
(3,15 mg)
OPA/Al/PE/desiccant/Al blister    EU/1/08/469/052  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/08/469/052
Date of authorisation Sep 12, 2008
Marketing authorisation holder, country KRKA, d.d., Novo mesto, Slovenia