Sinemet CR 50mg/200 mg Prolonged-release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levodopa; Carbidopa

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

N04BA; N04BA02

INN (International Name):

Levodopa; Carbidopa

Dosage:

50 mg/ 200 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Authorization status:

Marketed

Authorization date:

1991-12-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINEMET
® CR 50 MG/200 MG PROLONGED-RELEASE TABLETS
HALF SINEMET
® CR 25 MG/100 MG PROLONGED-RELEASE TABLETS
(Carbidopa/levodopa)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1
What Sinemet CR is and what it is used for
2
Before you take Sinemet CR
3
How to take Sinemet CR
4
Possible side effects
5
How to store Sinemet CR
6
Further information
1 WHAT SINEMET CR IS AND WHAT IT IS USED FOR
Sinemet CR improves the signs of Parkinson’s disease. Parkinson's
disease is a long-
term illness where:

you become slow and unsteady

your muscles feel stiff

you may develop shaking or trembling (called ‘tremor’).
If not treated, Parkinson's disease can make it hard for you to
continue your normal
daily activities.
Sinemet CR contains two different medicines called: levodopa and
carbidopa.

levodopa turns into a material called ‘dopamine’ in your brain.
The dopamine
helps to improve the signs of your Parkinson’s disease.

carbidopa belongs to a group of medicines called ‘aromatic amino
acid
decarboxylase inhibitors’. It helps levodopa work more effectively
by slowing the
speed at which levodopa is broken down in your body.
2
BEFORE YOU TAKE SINEMET CR
DO NOT TAKE SINEMET CR IF:

you are allergic (hypersensitive) to carbidopa or levodopa or any of
the other
ingredients of Sinemet CR (listed in Section 6)

you have ever had skin cancer or you have any unusual moles which have
not
been examined by your doctor

you are taking certain medicines called ‘MAOIs’ (Monoamine Oxidase
Inhibitors) used for

Summary of Product characteristics

Health Products Regulatory Authority
17 October 2019
CRN0092C6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinemet CR 50mg/200 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Sinemet CR contains carbidopa (equivalent to 50 mg of
anhydrous carbidopa) and 200 mg levodopa.
For full list of excipients, _see section 6.1._
3 PHARMACEUTICAL FORM
Prolonged-release tablets.
Peach-coloured, oval-shaped tablet, deep score on one side, 521 on the
other.
The score line is not intended to facilitate breaking of the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antiparkinson agent.
Idiopathic Parkinson's disease, in particular to reduce off-period in
patients who previously have been treated with
levodopa/decarboxylase inhibitors, or with levodopa alone and who have
experienced motor fluctuations. The experience is
limited with ‘Sinemet’ CR and Half ‘Sinemet’ CR in patients
who have not been treated with levodopa before.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be taken orally.
‘Sinemet’ CR and Half ‘Sinemet’ CR tablets contain a 1:4 ratio
of carbidopa to levodopa (‘Sinemet’ CR: carbidopa 50
mg/levodopa 200 mg, Half ‘Sinemet’ CR 25 mg/100 mg per tablet).
The daily dosage of ‘Sinemet’ CR must be determined by
careful titration. Patients should be monitored closely during the
dose adjustment period, particularly with regard to
appearance or worsening of nausea or abnormal involuntary movements,
including dyskinesias, chorea and dystonia.
‘Sinemet’ CR and Half ‘Sinemet’ CR may only be administered as
whole tablets. So that the controlled release properties of the
product can be maintained, tablets should not be chewed, crushed, or
halved.
Standard antiparkinson drugs, other than levodopa alone, may be
continued while ‘Sinemet’ CR or Half ‘Sinemet’ CR are being
administered, although their dosage may have to be adjusted.
Since carbidopa prevents the reversal of levodopa effects caused by
pyridoxine