SINADOPA 100/25 levodopa 100 mg and carbidopa (as monohydrate) 25 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levodopa, Quantity: 100 mg; carbidopa monohydrate, Quantity: 27 mg (Equivalent: carbidopa, Qty 25 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; quinoline yellow aluminium lake; microcrystalline cellulose; crospovidone

Administration route:

Oral

Units in package:

20 tablets, 100 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SINADOPA 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. SINADOPA frequently is helpful in the management of tremor, dysphagia, sialorrhoea and postural instability associated with Parkinson's disease and syndrome.

Product summary:

Visual Identification: Round, light yellow uncoated tablets with 'C' on one side and '19' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-01-11

Patient Information leaflet

SINADOPA
_Levodopa/Carbidopa_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about SINADOPA. 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 using SINADOPA
against the benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT SINADOPA IS USED FOR
SINADOPA 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.
SINADOPA 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.
SINADOPA 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, SINADOPA reduces some of
the symptoms of Parkinson's disease.
Your doctor may have prescribed SINADOPA for another reason. Ask your
doctor if you have any
questions about why SINADOPA has been prescribed for you.
BEFORE YOU USE SINADOPA
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE SINADOPA IF:
•
YOU HAVE AN ALLERG

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SINADOPA (LEVODOPA/CARBIDOPA)
1.
NAME OF THE MEDICINE
Levodopa and carbidopa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levodopa and carbidopa (as monohydrate) 250mg/25mg
Levodopa and carbidopa (as monohydrate) 100mg/25mg
_Carbidopa_
Carbidopa, an inhibitor of aromatic amino acid decarboxylase, is a
white, crystalline compound, slightly
soluble
in
water,
with
a
molecular
weight
of
244.3.
It
is
designated
chemically as (-) L-alpha-
hydrazino-alpha-methyl-beta-(3,4-dihydroxy-benzene) propanoic
acid monohydrate. Tablet content is
expressed in terms of anhydrous carbidopa, which has
a molecular weight of 226.3
_Levodopa_
Levodopa,
an
aromatic
amino
acid,
is
a
white,
crystalline
compound,
slightly
soluble
in
water,
with
a
molecular
weight
of
197.2.
It
is
designated
chemically
as
(-)
L-alpha-amino-
beta-(3,4-
dihydroxybenzene) propanoic acid.
For the full list of excipients, refer Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Levodopa/carbidopa is supplied as uncoated tablets for oral
administration.
250mg/25mg: Round, light blue uncoated tablets with ‘C’ on one
side and ‘20’ on the other side.
100mg/25mg: Round, light yellow uncoated tablets with ‘C’ on one
side and ‘19’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
SINADOPA 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. SINADOPA 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 levodopa/carbidopa must be determined by
careful titration in each
patient. SINADOPA tablets are available in a 4:1 ratio of levodopa to
carbidopa (Levodopa/carbidopa
100/25) as well as a 10:1 ratio (Levodopa/carbidopa 250/25). Tablets
of the two ratios may be given
separately or combined as needed to provide the optimum d