Sinemet Plus 25 mg/100 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbidopa; Levodopa

Available from:

PCO Manufacturing Ltd.

ATC code:

N04BA; N04BA02

INN (International Name):

Carbidopa; Levodopa

Dosage:

25/100 mg/mg

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Authorization date:

2021-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINEMET
® PLUS 25 MG/100 MG 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 is and what it is used for
2.
Before you take Sinemet
3.
How to take Sinemet
4.
Possible side effects
5.
How to store Sinemet
6.
Further information
1.
WHAT SINEMET IS AND WHAT IT IS USED FOR
Sinemet 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 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
DO NOT TAKE SINEMET IF:
•
you are allergic (hypersensitive) to carbidopa or levodopa or any of
the other
ingredients of Sinemet (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 depression. You need to stop using these medicines at least
two weeks
before you start Sinemet (se

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2024
CRN00F238
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinemet Plus 25 mg/100 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Sinemet Plus 25 mg/100 mg contains carbidopa
(equivalent to 25 mg of anhydrous carbidopa) and 100 mg
levodopa.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
_Products imported from Spain and Italy:_
Yellow, oval tablets with '650' and a score line on one side and plain
on the other. The score line is only to facilitate breaking
for ease of swallowing and not to divide into equal doses. If
subdivided, the tablet should be consumed as a whole dose.
4 CLINICAL PARTICULARS
As per PA23198/004/003
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/004/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Quinoline yellow (E104)
Pregelatinised starch
Corn starch
Microcrystalline cellulose
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package to protect
from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/AL blister packs of 100 tablets.
Health Products Regulatory Authority
01 February 2024
CRN00F238
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Not applicable.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/468/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1
st
April 2021
10 DATE OF REVISION OF THE TEXT
February 2024