SINEMET CR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CARBIDOPA AS MONOHYDRATE; LEVODOPA

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

N04BA02

Pharmaceutical form:

TABLETS CONTROLLED RELEASE

Composition:

LEVODOPA 200 MG; CARBIDOPA AS MONOHYDRATE 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic area:

LEVODOPA AND DECARBOXYLASE INHIBITOR

Therapeutic indications:

Idiopathic parkinson's disease. Postencephalitic parkinsonism. Symptomatic parkinsonism. To reduce "off" time in patients previously treated with levodopa/decarboxylase inhibitor preparations, or with levodopa alone, who have had motor fluctuations characterized by end-of-dose deterioration ("wearing-off" phenomenon), peak dose dyskinesias, akinesia, or similar evidence of short-duration motor disturbances.

Authorization date:

2023-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is dispensed with a
physician’s
prescription only
SINEMET
® CR
CARBIDOPA 50 MG/ LEVODOPA 200 MG
CONTROLLED RELEASE TABLETS
EACH TABLET CONTAINS:
ACTIVE INGREDIENTS: Carbidopa 50 mg/ Levodopa 200 mg
INACTIVE INGREDIENTS: see section 6 "Further information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
•
This leaflet contains concise information about SINEMET CR. If you
have any further questions,
refer to your doctor or pharmacist.
•
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others.
It may harm them, even if it seems to you that their ailment is
similar.
•
This medicine is not suitable for children and adolescents under 18
years of age
1.
WHAT IS SINEMET CR INTENDED FOR?
SINEMET CR
is used for the treatment of Parkinson’s disease and
Parkinsonism symptoms.
THERAPEUTIC GROUP: Anti-Parkinson agent.
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 the 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 the body.
2. BEFORE USING SINEMET CR
2.1 DO NOT USE SINEMET CR IF:
•
You are hypersensitive (allergic) to carbidopa or levodopa or any of
the other ingredients of
SINEMET CR (for a list of inactive ingredients, see 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 medi

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
SINEMET

CR 50 mg/200 mg Controlled-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.
3.
PHARMACEUTICAL FORM
Controlled-release tablets.
A peach-coloured, oval shaped tablet
marked "521" on one side and scored on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Idiopathic Parkinson's disease.
•
Postencephalitic parkinsonism.
•
Symptomatic parkinsonism.
•
To reduce "off" time in patients previously treated with
levodopa/decarboxylase
inhibitor preparations, or with levodopa alone, who have had motor
fluctuations
characterized by end-of-dose deterioration ("wearing-off" phenomenon),
peak dose
dyskinesias, akinesia, or similar evidence of short-duration motor
disturbances.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
'Sinemet CR' tablets contain a 1:4 ratio of carbidopa to levodopa
('Sinemet CR': carbidopa
50 mg/levodopa 200 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' may be administered as whole
or broken in half. So that the controlled release
properties of the product can be maintained, tablets should not be
chewed or crushed.
Standard antiparkinson drugs, other than levodopa alone, may be
continued while 'Sinemet
CR' is being administered, although their dosage may have to be
adjusted. Since carbidopa
prevents the reversal of levodopa effects caused by pyridoxine,
'Sinemet CR' can be given to
patients receiving supplemental pyridoxine (vitamin B6).
INITIAL DOSE
PATIENTS
CURRENTLY
TREATED
WITH
CONVENTIONAL
LEVODOPA/DECARBOXYLASE
INHIBITOR
COMBINATIONS
Dosage with 'Sinemet CR' should be substituted initially at an amount
that provides no mor