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

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

ORGANON PHARMA PTY LTD

Dawa fomu:

Tablet, modified release

Tungo:

Excipient Ingredients: hyprolose; magnesium stearate; ferric oxide; VA/Crotonates copolymer; quinoline yellow aluminium lake

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

100

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Idiopathic parkinsonism, where standard formulations containing levodopa/carbidopa have produced inadequate control. Experience is limited with Sinemet CR 200/50 in patients who have not been treated with levodopa before.

Bidhaa muhtasari:

Visual Identification: Peach-coloured, oval shaped, biconvex tablet, deep scored on,one side and the other marked 521; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Idhini hali ya:

Registered

Idhini ya tarehe:

2020-06-18

Taarifa za kipeperushi

SINEMET CR
®
200/50
_Levodopa-Carbidopa_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SINEMET CR
200/50. 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
200/50 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
200/50 IS USED FOR
SINEMET CR 200/50 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 200/50 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 200/50 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
200/50 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 200/50
reduces some of the symptoms of
Parkinson's disease.
Your doctor may have pr

Tabia za bidhaa

SINEMET CR 200/50 Tablet PI 20200618 (S-IPC/WPPI-MK0295B-CR-082013)
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
SINEMET
® CR 200/50 (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 200/50 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 peach-coloured, oval shaped, biconvex tablet,
deep scored on
one side and the other marked ‘521’.
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
200/50 in patients
who have not been treated with levodopa before.
4.2
DOSE AND METHOD OF ADMINISTRATION
SINEMET CR 200/50 tablets contain a 4:1 ratio of levodopa to carbidopa
(levodopa 200 mg/carbidopa 50 mg per tablet). The daily dosage of
SINEMET CR 200/50
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.
THE TABLETS MUST NOT BE BROKEN AND SHOULD BE TAKEN AS A WHOLE.
SINEMET CR 200/50 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