Apo-Levocarb tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levodopa, carbidopa

Available from:

Apotex Inc.

ATC code:

N04BA02 վերարտադրված դեղ

INN (International Name):

levodopa, carbidopa

Dosage:

250mg+ 25mg

Pharmaceutical form:

tablets

Units in package:

(100) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-10-23

Patient Information leaflet

IMPORTAN.I':
PLEASE
READ
PART
III:
CONSUMER INFORMATION
t'APo-LEvocARB
Levodopa and
Carbitlopa
Tablets
This leaflct
is a
summary
nnd
will
not
tell
you
everything
about
P'
APO-LEVOCARB.
Contact
your
doctor
or
pharmacist
ifyou
have any
questions
about the
drug.
Remember
-
This
medicine is
prescribed
fol
the
particular
condition that
you
have.
Do
not
give
this
medicine to
other
people,
nor
use
it
for
any
other
condition.
APO-LEVOCARB
is available only on
prescription
from
your physician.
What
the
medication
is used
for:
Your
physician
has
prescribed
APO-LEVOCARB
to
treat the
symptoms
of
Parkinson's
disease.
Parkinson's
disease
is
a
chronic disorder
characterized
by
slow
and
unsteady
movemenl,
muscular
stiffness,
and
trcmor.
[l
untreated,
Parkinson's
disease can cause
difäculty
in
perlorming
normal
daily
activities.
What it
does:
APO-LEVOCARB
is
a
combination
ollevodopa,
the
metabolic
precursor
ofdopamine,
and
carbidopa,
an
aromatic amino
acid decalboxylase
inhibitor.
It
treats
the symptoms
of
Parkinson's
disease.
It
is believed
that the syrnptoms of Parkinson's
disease are
caused
by
a lack
of
dopamine,
a
natulally
occuring chemical
produccd
by ceftain brain
cells.
Dopamine
has
the
role
of
relaying
messages
in
cefiain
regions
ofthe
brain that
control
muscle
movement.
Dilficulty
in
movement
results
when
too
little
dopamine
is
producecl.
Levoclopa acts
to
replenish dopamine
in
the
blain,
rvhile
carbidopa
ensurcs that enough
levoclopa
gets
to
the
blain
where
it
is
neecied.
In
rnany
patients,
this
reduces the
symptolxs
of
Parkinson's
disease.
When
it
should not
be
used:
Do
not take
APO-LEVOCARB:
.
are
allergic
to
any
ofits
ingledients
.
have
any
suspicious skin
lesions
(moles)
which
have
not
been examined
by
your
doctor
or
if
you
have
cvel
hacl
skin
cancer
I
ale
being
tleated
with
certain
MAO
inhibitor
drugs, such
as
lor
depression,
within
the
last
2 rveeks
.
have
narrow-angle
glaucoma
.
have untreated heart,
liver,
kidney, lung, blood or
holmonal
disease
r
have
been
told
that
you
should not
take
sympathomirnetic
drugs

Summary of Product characteristics

Appendix
1,9
1)
Name
of
the
Product:
Apo-LEVocARB
Tablets
1Omgi
100mg,
2bmg/100mg
and
25mgl250mg
(Carbidopa
and Levodopa
Tablets
USp)
2'l
Qualitative
and
Quantitative
Formula
.10.8
mg
rbidopa
US
equals
10
mg
of
Carbidopa
anhydrous
5 mg
of
Carbidopa
an
ydrous
i|:t
.
J
Ji.
oIh
Page
I
of
17
Apotex
pofska
$p.
z
o.o.
Ul
ûsirr.,brarnska
g5,
Û4-1ig
Warszawa
tei.
02231
12000,
fax
022s1
i
t0ò'ó-
Nlp:
t080016022
Component
and
Quality
Standard
(and
Grade,
if
applicable)
Function
of
Component
Yo
wlw
of
tablet
Quantity
per
unit
(mg/tablet)
10mg/100m9
Carbidopa
USP
(Micronized)
Active
5.14
10.9'
Levodopa
USP
Active
47.62
100.0
Microcrystalline
Cellulose
NF
(PH101)
Filler/Binder
24.9
52.2
Sorbitol
NF
Crystalline
Fines
Maintain
alkaline
pH
18.14
38,1
Croscarmellose
Sodium
NF
Disintegrant
1.90
4.0
Magnesium
Stearate
NF
Lubricant
1.90
4.0
lndigotine
Al
Lake
12-14o/o
(Blu
e#2)
Dye
0.23
0.5
Brilliant
Blue
FCF
At Lake
12%
Dye
0.19
0.4
Total
Tablet
Weight
100.0
21A.0
Quant¡ty
per
unit
(mg/tablet)
Component
and
Quality
Standard
(and
Grade, if
applicable)
Function
of
Component
%wlw oÍ
tablet
25mg/'t00mg
Carbidopa
USP
(Micronized)
Active
11.49
27.0*
Levodopa
USP
Active
42.55
100.0
Microcrystalline
Cellulose
NF
(PHl01)
Filler/Binder
23.62
55.5
Sorbitol
NF
Crystalline
Fines
Maintain
alkaline
pH
17.02
40.0
Croscarmellose
Sodium
NF
Disintegrant
1.70
4.0
Magnesium
Stearate
NF
Lubricant
2,13
5.0
D&C
Yellow
#
10
Atuminum
Lake
14-
18%
Dye
1,49
Itr
'
!:
,?',5,1
;{-
TotalTablet
Weight
100.0
'ì
'í
.2710
¡
rt
Ç
"27 0
mg
Carbidopa
SP
equals
ol-,ç4
Component
and
Quality
Standard
(and
Grade,
if applicable)
Function
of
Component
o/o
wlw
of
tablet
Quantlty
per
unit
(mg/tablet)
25mg/250m9
Carbidopa
USP
(Micronized)
Active
5.24
27,4*
Levodopa USP
Active
48.07
250.0
Microcrystalline Cellulose
NF
(PH101)
Filler/Binder
25.0
130.0
Sorbitol
NF
Crystalline
Fines
Maintain
alkaline
pH
18.09
94.1
Croscarmellose
Sodium NF
Disintegrant
1.92
10.0
Magnesium
Stearate
NF
Lubricant
1.53
8.0
lndigotine
Al Lake
12-14%
(Blue#2)
Dye
0.11
0.6
Brilliant Blue
FCF
AlLa