Solian tablets scored

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

amisulpride

Dostopno od:

Delpharm Dijon

Koda artikla:

N05AL05

INN (mednarodno ime):

amisulpride

Odmerek:

100mg

Farmacevtska oblika:

tablets scored

Enote v paketu:

(30/3x10) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2019-11-27

Navodilo za uporabo

17/11/2017 14:17 - VISTAlink folder 3017791 - Page 3/7
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIAN® 100 MG
,
SCORED TABLETS
amisulpride
WHAT IS IN THIS LEAFLET :
1. What Solian is and what it is used for
2. What you need to know before you take Solian
3. How to take Solian
4. Possible side effects
5. How to store Solian
6. Contents of the pack and other information .
1. WHAT SOLIAN IS AND WHAT IT IS USED FOR
Solian belongs to a group of medicines known as antipsychotics.
This medicine is used to treat people with schizophrenia.
Schizophrenia is a
mental illness characterized by various mental and behavioral
disorders, such
as hallucinations or agitation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIAN
CONTRAINDICATIONS:
DO NOT TAKE SOLIAN:
- if you are allergic to the active ingredient, amisulpride, or any of
the other
ingredients of Solian. See section 6 for a full list of ingredients.
- if you have a pheochromocytoma (excessive growth of the adrenal
glands
around the kidneys, releasing substances which cause high blood
pressure).
- in children under 15 years of age,
- if you are breast-feeding,
- if you have a prolactin-dependent tumor (prolactin is a hormone that
stimulates milk production), e.g. breast cancer or pituitary
disorders.
- if you are taking another medicine which should not be taken when
you are
already taking Solian (see “Taking or using other medicines”).
If you are unsure of anything, do not hesitate to ask your doctor or
pharmacist
for advice.
APPROPRIATE PRECAUTIONS FOR USE ; SPECIAL WARNINGS:
WARNINGS AND PRECAUTIONS FOR USE
Your doctor may ask you to have an electrocardiogram (ECG) before
starting
treatment. This medicine can cause heart rhythm disorders (see section
4,
“Possible side effects”).
This medicine should be used with caution in the following situations:
- in elderly patients, particularly if they have dementia, because of
the risk of
a drop in blood pressure and of drowsiness; in the case of patients
with
kidney failure, your doctor may reduce the dose,
- if you ha

Lastnosti izdelka

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,