Important Information from Organon Pharma/MSD on Sinemet Packaging
Organon Pharma (Ireland) Limited
2 Dublin Landings
N Wall Quay – North Dock
Dublin
D01 V4A3
Organon Pharma (Ireland) Limited. Registered Office: 2 Dublin Landings, N Wall Quay – North Dock, Dublin, D01 V4A3
Registration No. 673650. Directors: Gerard Brennan, Neil Boyle
August 2021
IMPORTANT INFORMATION
FOR HEALTHCARE PROFESSIONALS
Sinemet® Plus (carbidopa/levodopa) 25mg/100mg – PA1286/9/4
Sinemet® 12.5mg/50mg Tablets – PA1286/9/2
Packaging Change – from Blister packs to HDPE Bottles
Dear Healthcare Professional,
Organon Pharma (Ireland) Limited1 and Merck Sharp & Dohme Ireland (Human Health) Limited (‘MSD’), in agreement
with the Health Products Regulatory Authority (HPRA), would like to inform you of the following packaging change for the
above products:
Sinemet® Plus (carbidopa/levodopa) 25mg/100mg tablets will shortly become available in HDPE2 bottles. This switch to
bottles will replace the blister packaging over the coming months. It is anticipated that both blister and bottle packaging
will be available during this transitional period.
This change in packaging is in response to a number of reports from patients in Ireland who experienced tablet breakages
with Sinemet® Plus (carbidopa/levodopa) 25mg/100mg tablets during removal of the tablets from their blister packaging.
Supplying the tablets in HDPE bottles instead of in blister packs is intended to address that issue.
Previous communications sent to you in relation to use of the tablet score-line remain unchanged. (Please see summary
below.)
In order to ensure that patients take the correct dose of Sinemet® Plus 25mg/100mg and Sinemet 12.5mg/50mg tablets,
please continue to advise your patients as follows:
➢ The score-line on the tablets is not intended to sub-divide the tablet into two equal doses, and it should not
be used in that way.
➢ If a tablet must be sub-divided to aid in swallowing, the tablet should be consumed only if the whole dose
(i.e. all parts of the tablet) can be taken.
➢ Administration of a partial dose may result in worsening of symptoms.
Additionally:
Sinemet® 12.5mg/50mg tablets are of a similar tablet design, package configuration and formulation as the 25mg/100mg
tablets. Please also note that as part of this packaging change, we intend to also transition Sinemet 12.5mg/50mg from
blister packs to HDPE bottles in due course.
Instructions regarding the administration of other presentations of Sinemet®
remain unchanged.