SINEMET 250/25 levodopa/carbidopa 250 mg/25 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carbidopa monohydrate, Quantity: 27 mg (Equivalent: carbidopa, Qty 25 mg); levodopa, Quantity: 250 mg

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: indigo blue; maize starch; magnesium stearate; microcrystalline cellulose; pregelatinised maize starch

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SINEMET is indicated for the treatment of Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. SINEMET frequently is helpful in the management of tremor, dysphagia, sialorrhoea and postural instability associated with Parkinson's disease and syndrome.

Product summary:

Visual Identification: Light dapple blue oval tablet with 654 and a score line on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-11-15

Patient Information leaflet

SINEMET
®
_Carbidopa-Levodopa_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SINEMET. 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
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 IS
USED FOR
SINEMET 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 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 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. In many patients, SINEMET
reduces some of the symptoms of
Parkinson's disease.
Your doctor may have prescribed
SINEMET for another reason. Ask
your doctor if you have any questions
about why SINEMET has been
prescribed for you.
BEFORE YOU TAKE
SINEMET
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SINEMET IF:
•
YOU HAVE AN ALLERGY T

Summary of Product characteristics

Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
SINEMET
® (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.
SINEMET 250/25 tablets contain levodopa 250 mg and carbidopa 25 mg and
SINEMET
100/25 tablets contain levodopa 100 mg and carbidopa 25 mg.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SINEMET is supplied as tablets for oral administration.
SINEMET 250/25: light dapple blue oval tablet with 654 and a score
line on one side and
plain on the other.
SINEMET 100/25: yellow oval tablet with 650 and a score line on one
side and plain on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SINEMET is indicated for the treatment of Parkinson's disease and
syndrome. It is useful in
relieving many of the symptoms of parkinsonism, particularly rigidity
and bradykinesia.
SINEMET frequently is helpful in the management of tremor, dysphagia,
sialorrhoea and
postural instability associated with Parkinson's disease and syndrome.
4.2
DOSE AND METHOD OF ADMINISTRATION
The optimum daily dosage of SINEMET must be determined by careful
titration in each
patient. SINEMET tablets are available in a 1:4 ratio of carbidopa to
levodopa
(SINEMET 100/25) as well as a 1:10 ratio (SINEMET 250/25). Tablets of
the two ratios may
be given separately or combined as needed to provide the optimum
dosage.
The tablet score-line for SINEMET 100/25 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.
The tablet score-line for SINEMET 250/25 can be divided into equal
doses.
Page 2 of 12
GENERAL CONSIDERATIONS
Dosage should be titrated to individual patient needs and this may
require adjusting