STALEVO 50/12.5/200 levodopa/carbidopa (as monohydrate)/entacapone tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levodopa, Quantity: 50 mg; entacapone, Quantity: 200 mg; carbidopa monohydrate, Quantity: 13.5 mg (Equivalent: carbidopa, Qty 12.5 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; maize starch; mannitol; povidone; glycerol; hypromellose; polysorbate 80; iron oxide red; sucrose; titanium dioxide; iron oxide yellow

Administration route:

Oral

Units in package:

30 tablets, 100 tablets, 250 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Stalevo is indicated for the management of patients with Parkinson's disease who are experiencing motor fluctuations.

Product summary:

Visual Identification: Brownish- or greyish-red, round, biconvex tablets marked with 'LCE 50' on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-10-05

Patient Information leaflet

STALEVO
®
1
STALEVO
®
_Levodopa/carbidopa anhydrous/entacapone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Stalevo.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT STALEVO IS USED
FOR
Stalevo is used to treat the symptoms
of Parkinson's disease.
Parkinson's disease is a disorder of
the nervous system. It is caused by a
lack of dopamine, a natural substance
that is produced in the brain.
Dopamine relays messages in the
part of the brain that controls muscle
movement. When too little dopamine
is produced, problems with
movement result.
Stalevo contains three active
ingredients: levodopa, carbidopa
anhydrous and entacapone. Levodopa
is a chemical closely related to
dopamine, which allows the body to
make its own dopamine. Levodopa
works by increasing the level of
dopamine in the brain. Carbidopa
makes sure that enough levodopa
gets to the brain where it is needed,
and entacapone makes the effect of
levodopa last longer.
Stalevo helps to relieve symptoms
such as shaking of the limbs,
stiffness and slowness of movement,
which make it difficult to perform
normal daily activities. Other
medicines can also be added to help
treat this condition.
ASK YOU

Summary of Product characteristics

201105-stalevo-pi
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
STALEVO (LEVODOPA/CARBIDOPA MONOHYDRATE/ENTACAPONE) FILM-
COATED TABLETS
1.
NAME OF THE MEDICINE
Levodopa/carbidopa monohydrate/entacapone.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stalevo film-coated tablets are available in six strengths, each
containing a 4:1 ratio of levodopa
to carbidopa monohydrate combined with 200 mg of entacapone in a
standard release
formulation:
50/12.5/200
mg,
75/18.75/200
mg,
100/25/200
mg,
125/31.25/200
mg,
150/37.5/200 mg and 200/50/200 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Stalevo 50 mg/12.5 mg/200 are round, biconvex tablets marked with
‘LCE 50’ on one side.
Stalevo 75/18.75/200 are oval tablets marked with ‘LCE 75’ on one
side.
Stalevo 100/25/200 are oval tablets marked with ‘LCE 100’ on one
side.
Stalevo 125/31.25/200 are oval tablets marked with ‘LCE 125’ on
one side.
Stalevo 150/37.5/200 are elongated-ellipse shaped tablets marked with
‘LCE 150’ on one side.
Stalevo 200/50/200 are oval tablets marked with ‘LCE 200’ on one
side.
Stalevo strengths 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg
are brownish- or
greyish-red, film-coated tablets. Stalevo strength 200/50/200 mg is a
dark brownish-red film-
coated tablet. Stalevo strengths 75/18.75/200 mg and 125/31.25/200 mg
are light brownish red,
film-coated tablets.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Stalevo is indicated for the management of patients with Parkinson’s
disease who are
experiencing motor fluctuations.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
The optimum daily dosage of Stalevo must be determined by careful
titration in each patient.
The daily dose should preferably be optimised using one of the six
available tablet strengths
(50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg,
150/37.5/200 mg, or
200/50/200 mg levodopa/carbidopa monohydrate/entacapone).
Patients should be instructed to take only one Stalevo tablet per dose
administra