Legalon 140 capsules

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

silymarin

Disponibil de la:

Madaus GmbH

Codul ATC:

A05BA03

INN (nume internaţional):

silymarin

Dozare:

140mg

Forma farmaceutică:

capsules

Unități în pachet:

(20/2x10/), (30/3x10/) and (60/6x10/) in blister

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2017-11-07

Caracteristicilor produsului

Summary
of
P
r
od
u
c
t
C
h
a
r
a
c
t
e
r
i
s
t
i
c
s
1.
N
A
M
E OF THE MEDICINAL
P
R
O
D
U
C
T
LEGALON® 140
(active ingredient:) dried extract
of
milk thistle
f
ru
i
t
s
2. QUALITATIVE
AND
QU
A
N
T
I
T
A
T
I
V
E
COMPOSITION
1 capsule
con
t
ai
n
s
:
173.0 mg - 186.7
mg
of
d
r
i
e
d
extract
of
milk thistle fruits
(
3
6
-44
:
1
)
,
corresponding to 140 mg of
silymarin (DNPH), corresponding to 108.2 mg of silymarin (HPLC)
calculated as silibinin
(solvent: ethyl acetate).
-
For excipients, see section 6.1.
3.
P
H
A
RM
A
C
E
U
T
I
C
AL
F
O
R
M
C
a
ps
u
l
es
.
Brown hard
g
e
l
a
t
i
n
capsules
w
i
t
h
yellow powder as
c
on
t
e
n
t.
4.
CLINICAL
P
A
R
T
I
CU
L
A
R
S
4.1
Therapeutic indications
Toxic liver damage: for supportive treatment in patients with chronic
inflammatory diseases of the
liver or hepatic cirrhosis.
Note: This medicine is not suitable for treating cases of acute
poisoning.
4.2
P
o
s
ol
o
g
y
and method
of
a
d
m
i
n
i
s
t
r
a
t
i
o
n
Unless otherwise
p
r
e
scr
i
b
ed
:
adults and children over 12 years old are recommended
1
capsule
3
t
i
me
s
d
a
il
y
,
corresponding
to 420 mg
(
3
2
4
.
6
mg)
o
f
s
il
ym
a
r
i
n
d
a
il
y
.
The capsules are to be swallowed whole and unchewed
w
i
t
h
an
a
pp
r
o
p
r
i
a
t
e
amount of liquid.
The doctor will decide on the
d
u
r
a
t
i
o
n
of
the
t
r
e
a
t
m
e
nt.
_Use in children under 12 years of age: _
This medicine is not intended for use in children under 12 years of
age.
_Method of administration and duration of treatment: _
For oral use the hard capsules are to be taken unchewed with an
appropriate amount of liquid.
The duration of treatment is determined by the doctor individually,
depending on the nature and
characteristics of the course of the disease.
4.3
C
o
n
t
r
a
in
d
i
c
a
t
i
o
n
s
Legalon
1
4
0
should
n
ot
be administered
i
n
cases
of
known
h
y
pe
r
s
e
n
s
i
t
i
v
i
ty
against milk
t
h
i
s
t
l
e
fr
u
i
t
s
,
other composites or any
of
the e
x
c
i
p
i
e
n
t
s
.
4
.
4
Special
warnings
and
special
p
r
e
c
a
u
t
i
o
n
s
for use
The
t
r
ea
t
m
e
n
t
with this