SERC 16 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
14-09-2016
Summary of Product characteristics
(SPC)
14-09-2016
Active ingredient:
BETAHISTINE HYDROCHLORIDE
Available from:
BGP Products Ltd
ATC code:
N07CA01
INN (International Name):
BETAHISTINE HYDROCHLORIDE
Dosage:
16 Milligram
Pharmaceutical form:
Tablets
Administration route:
oral use
Units in package:
10, 20 or 84 tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic group:
Anti-vertigo preparations
Therapeutic area:
Antivertigo preparations
Therapeutic indications:
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
Authorization status:
Authorised
Authorization date:
2015-03-27
Patient Information leaflet
P. Process Black U -
Cutting Die (not printed)
MKP-00377-2016_d4
Bet
ahi
stin
e d
ihyd
roc
hlor
ide
REA
D ALL O
F TH
IS L
EAFL
ET C
ARE
FU
LLY
BEF
ORE Y
OU S
TA
RT T
AKI
NG T
HIS
MEDICIN
E.
•
Kee
p thi
s lea
flet
. You m
ay n
eed t
o
rea
d it a
gai
n.
•
If y
ou h
ave a
ny f
urt
her q
ues
tion
s,
ask
you
r do
cto
r o
r p
harm
acis
t.
•
Thi
s med
ici
ne h
as b
een p
res
crib
ed
for y
ou. D
o not p
ass i
t on t
o oth
ers
.
It may h
arm t
hem
, eve
n if t
hei
r
sym
pto
ms a
re t
he s
am
e as y
our
s.
•
If a
ny o
f the s
ide e
ffe
cts b
eco
mes
ser
iou
s, o
r if y
ou n
otic
e any
sid
e eff
ect
s not l
ist
ed i
n thi
s
lea
flet
, ple
ase t
ell y
our d
oct
or o
r
pha
rm
acis
t.
IN T
HIS L
EAFL
ET:
1.
Wha
t Ser
c is a
nd w
hat i
t is u
sed f
or
2.
Bef
ore y
ou t
ake S
erc
3.
How t
o tak
e Ser
c
4.
Pos
sibl
e sid
e e
ffe
cts
5.
How t
o sto
re S
erc
6.
Fur
the
r inf
orm
atio
n
1.
WHA
T SER
C IS A
ND W
HAT I
T IS U
SED F
OR
Ser
c con
tai
ns b
eta
his
tine
. Ser
c is a
typ
e of m
ed
ici
ne c
alle
d a “hi
sta
min
e
ana
logu
e”.
Ser
c is u
sed f
or:
Mén
ièr
e’s d
ise
ase – t
he s
ign
s of t
his
inclu
de:
•
fee
lin
g diz
zy (
ver
tigo
)
•
rin
gin
g in t
he e
ars (ti
nni
tus
)
•
hea
rin
g los
s or h
ear
ing d
iffi
cul
ty
Thi
s med
ici
ne w
ork
s by i
mpr
ovi
ng
blo
od fl
ow i
n the i
nne
r ear
. Thi
s low
ers
the b
uild u
p of p
res
sur
e.
2.
BEF
ORE Y
OU T
AKE S
ERC
DO N
OT T
AKE S
ERC I
F:
•
you a
re a
lle
rgi
c (hy
per
sen
siti
ve)
to b
eta
his
tine o
r any o
f the o
the
r
ing
red
ien
ts i
n the t
abl
ets (
see
sec
tion 6 f
or f
urt
her d
eta
ils
)
•
you h
ave h
igh b
loo
d pre
ssu
re
due t
o an a
dre
nal g
lan
d
tumo
ur(p
hae
och
romo
cyt
oma
)
If a
ny o
f the a
bov
e app
lie
s to y
ou, d
o not
tak
e thi
s med
ici
ne a
nd t
alk t
o you
r doc
tor
.
TAK
E SPE
CIA
L CAR
E AND T
ELL Y
OUR D
OCT
OR I
F:
•
you h
ave e
ver h
ad a s
tom
ach u
lce
r
•
you h
ave a
sth
ma
•
you a
re p
reg
nan
t or p
lan
nin
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serc 16mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg betahistine dihydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet:
Round, biconvex, scored, white to almost white tablets imprinted `267' on one face.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage for adults is 8 -16 mg three times daily taken preferably with meals.
Paediatric population:
Serc is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Geriatric population:
Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests
that no dose adjustment is necessary in this patient population.
Renal impairment:
There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose
adjustment appears to be necessary.
Hepatic impairment:
There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose
adjustment appears to be necessary.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Use in phaeochromocytoma.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with bronchial asthma and history of peptic ulcer need to be carefully monitored during the therapy.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 30/08/2016_
_CRN 2175554_
_page number: 1_
4.5 INTERACTION WITH
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