SINEMET CR levodopa/carbidopa 200 mg/50 mg modified release tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

carbidopa monohydrate, Quantity: 54 mg (Equivalent: carbidopa, Qty 50 mg); levodopa, Quantity: 200 mg

Tilgængelig fra:

ORGANON PHARMA PTY LTD

INN (International Name):

carbidopa monohydrate,Levodopa

Lægemiddelform:

Tablet, modified release

Sammensætning:

Excipient Ingredients: indigo carmine; hypromellose; hyprolose; allura red AC; magnesium stearate

Indgivelsesvej:

Oral

Enheder i pakken:

10, 100

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. Experience is limited with Sinemet CR in patients who have not been treated with levodopa before.

Produkt oversigt:

Visual Identification: Dappled purple, oval tablet plain on one side with 521 on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2011-04-13

Indlægsseddel

SINEMET CR
®
_Levodopa-Carbidopa_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SINEMET CR. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SINEMET CR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SINEMET CR IS
USED FOR
SINEMET CR is used to treat some
of the symptoms of Parkinson's
disease. This is a disease of the
nervous system that mainly affects
body movement. The three main
symptoms are shaking (tremor),
muscle stiffness and slow and
unsteady movement. People with
Parkinson's disease often walk with a
shuffle as they have difficulty in
initiating movement. If untreated,
Parkinson's disease can cause
difficulty in performing normal daily
activities.
SINEMET CR is most helpful in
improving slow movement and
muscle stiffness. It is also frequently
helpful in treating shaking, difficulty
in swallowing and drooling.
The symptoms of Parkinson's disease
are caused by a lack of dopamine, a
naturally occurring chemical
produced by certain brain cells.
Dopamine relays messages in the
part of the brain that controls muscle
movement.
When too little dopamine is produced
slowness of movement results.
SINEMET CR contains two active
ingredients, levodopa and carbidopa.
Levodopa is a chemical closely
related to dopamine which allows the
body to make its own dopamine.
Carbidopa makes sure that enough
levodopa gets to the brain where it is
needed. SINEMET CR is formulated
to slowly release the levodopa and
carbidopa. This keeps the amount of
levodopa in your brain as even as
possible. In many patients,
SINEMET CR reduces some of the
symptoms of Parkinson's disease.
Your doctor may have prescribed
SINEMET CR for another reason.
Ask your doctor if you

Produktets egenskaber

SINEMET CR Tablet PI 20190906 (S-IPC/WPPI-MK0295B-CR-082013)
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
SINEMET
® CR (LEVODOPA AND CARBIDOPA) TABLET
1
NAME OF THE MEDICINE
Levodopa and carbidopa
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Carbidopa _
Carbidopa, an inhibitor of aromatic amino acid decarboxylase, is a
white, crystalline
compound, slightly soluble in water.
_Levodopa _
Levodopa, an aromatic amino acid, is a white, crystalline compound,
slightly soluble in
water.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SINEMET CR 200/50 (levodopa 200 mg and carbidopa 50 mg) is supplied as
tablets for oral
administration. SINEMET CR is a controlled-release formulation of
levodopa, and
carbidopa, in a ratio of 4:1. The tablet contains a polymer-based drug
delivery system which
controls the release of levodopa and carbidopa as it slowly erodes.
SINEMET CR 200/50 is a dappled, purple, oval tablet, plain on one side
with 521 on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Idiopathic parkinsonism, where standard formulations containing
levodopa/carbidopa have
produced inadequate control. Experience is limited with SINEMET CR in
patients who have
not been treated with levodopa before.
4.2
DOSE AND METHOD OF ADMINISTRATION
SINEMET CR tablets contain a 4:1 ratio of levodopa to carbidopa
(levodopa 200 mg/carbidopa 50 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.
SINEMET CR should only be administered as whole tablets. 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 p