Sinemet 10 mg/100 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbidopa; Levodopa

Available from:

Organon Pharma (Ireland) Limited

ATC code:

N04BA; N04BA02

INN (International Name):

Carbidopa; Levodopa

Pharmaceutical form:

Tablet

Therapeutic area:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Authorization status:

Marketed

Authorization date:

1979-04-01

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 t

Summary of Product characteristics

Health Products Regulatory Authority
13 October 2023
CRN00DSF1
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinemet 10 mg/100 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Sinemet 10mg/100mg contains carbidopa (equivalent to 10
mg of anhydrous carbidopa) and 100 mg levodopa.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Dark dapple blue, oval tablets, with '647' 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
4.1 THERAPEUTIC INDICATIONS
Antiparkinsonian agent.
For treatment of Parkinson's disease and syndrome. Sinemet is useful
in relieving many of the symptoms of parkinsonism,
particularly rigidity and bradykinesia. It is frequently helpful in
the management of tremor, dysphagia, sialorrhoea, and postural
instability associated with Parkinson's disease and syndrome.
When response to levodopa alone is irregular, and signs and symptoms
of Parkinson's disease are not controlled evenly
throughout the day, substitution of Sinemet usually reduces
fluctuations in response. By reducing some of the adverse
reactions produced by levodopa alone, Sinemet permits more patients to
obtain adequate relief from the symptoms of
Parkinson's disease.
Sinemet may be given to patients with Parkinson's disease and syndrome
who are taking vitamin preparations that contain
pyridoxine hydrochloride (Vitamin B6).
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 as:-
Sinemet 12.5mg/50mg containing carbidopa PhEur equivalent to 12.5 mg
of anhydrous carbidopa and 50 mg levodopa. 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