SINEMET CR

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CARBIDOPA AS MONOHYDRATE; LEVODOPA

MAH:

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_group:

LEVODOPA AND DECARBOXYLASE INHIBITOR

therapeutic_area:

LEVODOPA AND DECARBOXYLASE INHIBITOR

therapeutic_indication:

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:

2013-02-28

PIL

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon 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 "What SINEMET CR contains".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about SINEMET CR. 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 ailment seems 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 medicines called ”MAOIs” (Monoamine

SPC

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