Solian

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

amisulpride

MAH:

Sanofi Winthrop Industrie

INN:

amisulpride

dosage:

200mg

pharmaceutical_form:

tablets scored

prescription_type:

Prescription

PIL

SOLl AN®
_aniisulpride _
50
mg
tablets
100 m g an d 200
mg
sc o red t
able
ts
400 mg
sco
red fi lm-coated
table
ts
Read a ll
of th is
le afl e t ca r
efully
befor
e you S
hir
t
us in g thi s
m edi
cin
e.
.Keep
this
leaflet, You
m ay
need
to read
it
again.If
you
have
any
questions
or are u nsure
of
anything,
a
sk
yo ur d
octor
or
p
harm
acist fo r mo re inf
orm
ation. T
his
med icine has
bee
n
prescribed
for you. Do not
pass
i(
on to
oth
ers .
It
ma
y
harm
t
hem
, e
ve
n if their s
ymptoms
are the sam e as yo
urs
.
. .If any
of
the
side
effe
ct
s b
ecome
s
se
rious.
or
if
you
notice any
side
effe
cts
not
list
ed in this leaflet,
I
p
lease
tell
y
_~ur
doctor
or
ha
rm acist.
I
II
thi
s
lea
nct
:
1.
Wh
at S
olian
t
ablet
s are an d w
hat
they are u
sed
for
2 . B
ef
or
e you rake Soli an
tab
le ts
3.
How
to t
ake
So lian tab le ts
4.
Possi ble side
ef
fec ts
_S. _
How to
sto
re
Solian
tab let s
6. Further
informati
on
l.
WHAT Solian tablets
AR
E AND
WHAT
TH
EY ARE USED
FOR
This is an anti-psy chotic
drug.
This drug
is
int e
nded
for
the
treatm ent
of
certain m
enta
l d is
order
s
and
behav ioral
disturbances
.
2. UE
FOnE
v
on
TAK
E
SOLI
Al '
T ABLETS
Neve
r ta
ke
So
l
ian
ta b le ts in t
he
follow ing s
itu
at
io ns:
•
If
you hav e a pheo chr o
mo
cyto ma
(
gro
wt
h of the adre
na
l
medu
llary g la nd
secreti
ng su bsta
nces
that
induce severe hyperrension),
• chi
ldren under 15 years
or
age,
• breas t-feed ing.
• k
now
n allergy to a
mis
ulprid e
or
to any
of
th e other ingredien ts,
· kn own pro lactin-dep
endent
tum or.
• in combinatio n
w ith lev od op a
(medi cine
used for
Parkinson' s
disease)
(see
"Taking/using
ot h
er
med icines " ).
IF
YOU
ARE UNSURE OF ANYTHI NG. IT IS ESSENTIAL THAT YOU ASK YOUR DOCTOR
OR
PHARMACIST
f OR
.
A.
D VICE.
Tuke
sp ecial
care
w it h S
olian
t
ablet
s
S pecial w a
rn
in gs
If you
exp
erience
mus
c le rigidity. consciousn ess di
sorders
accompanied
by
une
xplained
fever du ring
treatment. sto p taking
Soli
an im m ed iately and
conta
ct a
doct
or ur
gently
.
Your doctor

SPC

SUMMARY
OF
PRODUCT CHA RACTERI S
TI
CS
1.
NAME
AND DOSAGE OF
THE
MEDl
CINAL
PRODUC
T
SOLI AN"l
50
mg
tablets
100
mg
and 200 m g s
core
d
tablets
40 0
mg scored film-coated table ts
2.
QU
ALITA
TI
VE AND QUA
NTI
TATIVE
COMPO
SITION
50
mg
tablets
:
T he
active
su bs ta n ce is:
Arnisulpride
"
50 mg
For one tablet.
The
other
ingr
cd
ient
s
a re:
sodium
starch
glycola te
(Type
_A), _
lactose
monohydrate,
microcrystalline cellulose,
hyprom eltose,
magnesium stearate.
100 mg score d
tabl
et s:
The
activ
e
subs ta nce
is:
Am
isulpride
I00 mg
For
one
scored tablet.
The
other
ingredient
s
a rc:
sodium
starch
glycolate
(Type
_A ), _
lactose
mono hydra te,
III
icr ocry sta! l
i
ne ce
llul
ose,
hyprornellose, magnesium stearate.
200
mg
scored
ta blets
T he
active substa nce is:
Amisulpride
200
rng
For
one sco red tab let.
T he
other
in
gredi
ents
a re:
sodium
starc h
glycolate
(Type
A) ,
lactose
monohydrate,
rnicrocrystalline
cellu lose,
hyprornel lose,
magnesiu m stearate.
400
mg
sc
or
ed film-coa ted tablets:
The
active
substa nc e
is:
A
111
isulpride
.400 mg
For one sco red
fi
lm-coated
til
blet.
Th e
other
ingred icnts
arc
:
sodium
starch
glycolate
(type
A),
monohydra te
lactose,
microcrysta lline ce llulose,
hyp
ror
n ellose,
magnesium stearate, White Sepifi lm 752*
H PRO
VE
0
BY
seD
~
\
1,[
~
)
EX
PER
TIn
AlL
_•_
_ifL_
_t'I_
_/_
_tJ3 _
_« «, _
!..
P
PL
I
C:NT/O~
.
T~
_til/I. _
_w_
_it _
...
composition
of
White Scpifilm 752 : hypromellose, microcrystalline cellulose.
polyo
xyl40
stearate, titanium diox ide
(E
J
7
I)
.
3.
P
HARMA
CEUTI CAL FORM
50
mg
tab lets
100
mg
and
200
mg
scored tablets
4UU
mg
scored
f
lm- c
oat
ed
tablets
3.1
Method
and
route of
admini
s t
rati
on
Oral use.
4.
CLINICAL
DATA
4.1
WHAT SOLl AN T ABLETS ARE AND WHAT
THEY
ARE USED
FOR
•
This is an anti-psychotic drug.
•
This drug is intended for the treatment of' certain mental disorders
and behavioral
disturbances,
4.2
Posology
and
method
of
administration
Dosage
Usually,
if
the
dail y
dose does not exceed 400 rug, it can be taken once a day,