Sermion tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nicergoline

Available from:

Pfizer Italia S.r.L.

ATC code:

C04AE02

INN (International Name):

nicergoline

Dosage:

30mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/2x15/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-12-13

Summary of Product characteristics

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4,3
Contraindications
A
regent
myocardial
infarction,
acuts
bleeditrg,
prouorlnced
bradycarclia,
impairment
of
orthostatic
rogulation,
hypersensitivity
to nicergoline,
other
ergotamine
derivatives
or
oth",
ingre6lents
of
tne
drug,
sucrase/issmaltase
deficiency,
fmctose
intoierance,
glucose-galactose
mala'buoiption.
og"
under
lB,
pregnancy
and
breastfeeding.
4.4
Special
lvarnings
and
precautions
for
use
Clinical
trials
have
showu
that
single
or
multiple
use
of
nicergoline
could
cause
a
decrease
in
_srystolic
and,
to
a
greater
exteut,
diastoiic
blood
pressrire
in
paiients
with
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blood
pressure.
Tliese
rcsults
may
vary,
since
other
shldiei
have
shown
no
change
i1
blood
prsssure'
The
effect
of
the
drug
is
gradual;
theref,ore,
it
should
be taken
for
a
long
time.
and
the
physician
should
evaluate
the
effect
of
treatment
and
ihe
fbasibiliry
of
its
contjnu"ti?"
p".j-Jj""rrv
(at
least
every
6
monthsJ.
An
association
with
fibrosis
{for
example,
lung,
hea$,
heart
vaive
and
retroperitoneal
fibrosis)
las
obssrved
whel
adnrinistering
ergot
alkaloids
having
agcnistic
activily
towards
5HT2p
serotonin
receptors
The
symptoms
of
ergotism (includingnAusea,
vomiting,
diarrhoea,
abdominal
pain
ancl
peripheral
vasoconstriction)
have
been
reported
during
the
administration
of
certain
ergot-alkaloids
and
their
derivatives.
Doctsrs
should
be aware.of-the
potential
syffiptoms
r:f,overdosage
of
ergot
products
prior
to
prescribing
the
drugs
ofthis
class.
A
history
of
hyperuricaemia
or
gout
ancVor
use
in
combination
rvith
me
                                
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Patient Information leaflet Patient Information leaflet Russian 08-11-2019

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