Sinemet 25mg/250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbidopa monohydrate; Levodopa

Available from:

Organon Pharma (UK) Ltd

ATC code:

N04BA02

INN (International Name):

Carbidopa monohydrate; Levodopa

Dosage:

25mg ; 250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5013945002133 5013945300499

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINEMET
® 10 MG/100 MG TABLETS
SINEMET
® PLUS 25 MG/100 MG TABLETS
SINEMET
® 25 MG/250 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

Summary of Product characteristics

OBJECT 1
SINEMET 12.5MG/50MG TABLETS
Summary of Product Characteristics Updated 25-Oct-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
SINEMET
®
12.5 mg/50 mg Tablets
SINEMET
®
10 mg/100 mg Tablets
SINEMET
®
Plus 25 mg/100 mg Tablets
SINEMET
®
25 mg/250 mg Tablets
2. Qualitative and quantitative composition
Each tablet of 'Sinemet 12.5 mg/50 mg Tablets' contains 13.5 mg
carbidopa (equivalent to 12.5 mg of
anhydrous carbidopa) and 50 mg levodopa.
Each tablet of 'Sinemet 10 mg/100 mg Tablets' contains 10.8 mg
carbidopa (equivalent to 10 mg of
anhydrous carbidopa) and 100 mg levodopa.
Each tablet of 'Sinemet Plus 25 mg/100 mg Tablets' contains 27.0 mg
carbidopa (equivalent to 25 mg of
anhydrous carbidopa) and 100 mg levodopa.
Each tablet of 'Sinemet 25 mg/250 mg Tablets' contains 27.0 mg
carbidopa (equivalent to 25 mg of
anhydrous carbidopa) and 250 mg levodopa.
3. Pharmaceutical form
Tablets.
'Sinemet 12.5 mg/50 mg Tablets': yellow, oval-shaped tablets, one side
scored and the other marked '520'.
'Sinemet 10 mg/100 mg Tablets': light dapple blue, round tablets, with
'647' on one side and plain on the
other.
'Sinemet Plus 25 mg/100 mg Tablets ': yellow, round tablets with '650
on one side and plain on the other.'
'Sinemet 25 mg/250 mg Tablets ': light dapple blue, round tablets,with
'654' on one side and plain on the
other.
For excipients see 6.1.
4. Clinical particulars
4.1 Therapeutic indications
Antiparkinsonian agent.
For treatment of Parkinson's disease and syndrome.
4.2 Posology and method of administration
To be taken orally.
The optimum daily dosage of 'Sinemet' must be determined by careful
titration in each patient.
'Sinemet' Tablets are available in a ratio of 1:4 or 1:10 of carbidopa
to levodopa to provide facility for
fine dosage titration for each patient.
GENERAL CONSIDERATIONS
Studies show that the peripheral dopa-decarboxylase is fully inhibited
(saturated) by carbidopa at doses
between 70 and 100 mg a day. Patients receiving less than this amount
of carbidopa are more likely