Half Sinemet CR 25mg/100mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Carbidopa monohydrate; Levodopa

Dostępny od:

Organon Pharma (UK) Ltd

Kod ATC:

N04BA02

INN (International Nazwa):

Carbidopa monohydrate; Levodopa

Dawkowanie:

25mg ; 100mg

Forma farmaceutyczna:

Modified-release tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04090100; GTIN: 5013945002164

Ulotka dla pacjenta

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

Charakterystyka produktu

OBJECT 1
SINEMET CR AND HALF SINEMET CR
Summary of Product Characteristics Updated 25-Oct-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
SINEMET® CR 50 mg/200 mg Prolonged-Release Tablets
HALF SINEMET® CR 25 mg/100 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.
Each tablet of 'Half Sinemet CR' contains carbidopa (equivalent to 25
mg of anhydrous carbidopa) and
100 mg levodopa.
3. Pharmaceutical form
Modified-release tablets.
'Sinemet CR': peach-coloured, oval shaped, biconvex tablets, one side
deep-scored and the other marked
'521'.
'Half Sinemet CR': pink-coloured, oval-shaped, biconvex tablets, plain
one side and the other marked
'601'.
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
'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.
ROUTE OF ADMINISTRATION: ORAL
'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 whi