STALEVO 150/37.5/200MG FILM-COATED TABLETS

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

CARBIDOPA; LEVODOPA; ENTACAPONE

Dostępny od:

ORION PHARMA (MY) SDN. BHD.

INN (International Nazwa):

CARBIDOPA; LEVODOPA; ENTACAPONE

Sztuk w opakowaniu:

30Tablet Tablets; 100Tablet Tablets; 250Tablet Tablets

Wyprodukowano przez:

ORION CORP

Ulotka dla pacjenta

_Consumer Medication Information Leaflet (RiMUP) _
STALEVO
® FILM COATED TABLET
LEVODOPA/CARBIDOPA/ENTACAPONE
(50/12.5/200 MG, 75/18.75/200 MG, 100/25/200 MG,
125/31.25/200 MG, 150/37.5/200 MG, 200/50/200 MG)
1
WHAT IS IN THIS LEAFLET
1.
WHAT STALEVO IS USED FOR
2.
HOW STALEVO WORKS
3.
BEFORE YOU USE STALEVO
4.
HOW TO USE STALEVO
5.
WHILE USING STALEVO
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
STALEVO
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT STALEVO IS USED FOR
Stalevo contains three active
substances in one film-coated
tablet. Each tablet contains
levodopa, used to treat the
symptoms of Parkinson’s disease.
The two other active substances:
carbidopa and entacapone
improve the antiparkinson effects
of levodopa.
HOW STALEVO WORKS
Your doctor has prescribed
Stalevo to treat your 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.
Levodopa works by increasing the
level of dopamine in the brain.
Stalevo helps in relieving the
symptoms of Parkinson’s disease,
such as shaking of the limbs, and
stiffness and slowness of
movement, which make it
difficult to perform normal daily
activities.
You may also be given other
medicines to help treat this
condition.
Ask your doctor if you have any
questions about how this
medicine works or why this
medicine has been prescribed for
you.
BEFORE YOU USE STALEVO
_When you must not use it: _
•
If you are allergic
(hypersensitive) to levodopa,
carbidopa or entacapone or
any of the other ingredients
of Stalevo.
•
If you have a severe liver
impairment.
•
If you have narrow-angle
glaucoma (an eye disorder).
•
If you have a tumour of the
adrenal gland
(known as
pheochromocytoma; this may
increase the risk of severe
high blood pressure)
.
•
If you are taking, or

Charakterystyka produktu

Stalevo 
Anti-parkinson drugs, dopa and dopa derivatives
COMPOSITION AND PHARMACEUTICAL FORM
Stalevo 50 mg/12.5 mg/200 mg : each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa
and 200 mg of entacapone. They are brownish- or greyish -red, round, convex, unscored film -
coated tablets marked with ‘LCE 50’ on one side .
Stalevo 75 mg/18.75 mg/200 mg: each tablet contains 75 mg of levodopa, 18.75 mg of
carbidopa and 200 mg of entacapone . They are light brownish red, oval-shaped, film-coated
tablets marked with ‘LCE 75’ on one side .
Stalevo 100 mg/25 mg/200 mg : each tablet contains 100 mg of levodopa, 25 mg of carbidopa
and 200 mg of entacapone. They are brownish- or greyish -red, oval -shaped, unscored film -
coated tablets marked with ‘LCE 100’ on one side.
Stalevo 125 mg/31.25 mg/200 mg: each tablet contains 125 mg of levodopa, 31.25 mg of
carbidopa and 200 mg of entacapone . They are light brownish red, oval-shaped, film-coated
tablets marked with ‘LCE 125’ on one side .
Stalevo 150 mg/37.5 mg/200 mg : each tablet contains 150 mg of levodopa, 37.5 mg of
carbidopa and 200 mg of entacapone . They are brownish- or greyish -red, el ongated -ellipse
shaped unscored film -coated tablets marked with ‘LCE 150’ on one side.
Stalevo 200 mg/50 mg/200 mg : each tablet contains 200 mg of levodopa, 50 mg of carbidopa
and 200 mg of entacapone. They are dark brownish- or greyish -red, oval -shaped unscored film -
coated tablets marked with ‘LCE 200’ on one side.
For a full list of excipients, see section EXCIPIENTS.
Certain dosage strengths may not be available in all countries.
INDICATIONS
Stalevo ® (carbidopa, levodopa and entacapone) is indicated to treat patients with idiopathic
Parkinson’s disease :
1) To substitute (with equivalent strength of each of the three components) for immediate
release carbidopa/levodopa and entacapone previously administered as individual
products.
2) To replace immediate release carbidopa/levodopa therapy (without entacapone) when
patients experience the