Elofenal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fenspiride (fenspiride hydrochloride)

Available from:

Polfarmex S.A.

INN (International Name):

fenspiride (fenspiride hydrochloride)

Dosage:

2mg/ml

Pharmaceutical form:

syrup

Prescription type:

Prescription

Patient Information leaflet

PACKAGE
LEAFLET:
INFORMATION
FoR
THE
USER
ELOFENAL,
2
mglml,
syrup
(F
e
ns
pir
idi
hy
dr
ochloridum)
Read
all
ofthis
leaflet
carefully
before
you
start
taking
this
medicine.
-
Keep
this leaflet.
You
may
need
to
read
it
again.
-
If
you
have
any
firrther
questions,
please
ask
your
doctor
or
pharmacist.
-
This
medicine
has
been
prescribed
for
you.
Do
not
pass
it
on
to
otheru.
It
may harm
them,
even
if
their
symptoms
are
the
same
as
yours.
-
If
any
of
the
side
effects
get
serious,
or
you
notice
any
side
effects
not listed
in
this
leaflet,
please
tell
your
doctor
or
pharmacist.
In
this leaflet:
1.
What
Elofenal
is
and
what
it
is
used
for
2.
Before you
take
Elofenal
3.
How
to
take
Elofenal
4.
Possible
side
effects
5.
How
to
store
Elofenal
6.
Further
information
1.
What
Elofenal
is
and
what
it
is
used
for
The active
substance
of
medicine
is fenspiride,
which
has
anti-inflammatory
and
decontracting
effect
on
bronchial
tubes.
Its
anti-inflammatory
activity
consists
in
reducing
generation
of
mediators
of
inflammatory
processes
(cytokines,
TNF-o,
arachidonic
acid
derivatives,
free
radicals).
As histamine
Hl
receptor
antagonist
it
reduces:.
-
swelling
ofthe
mucosa
of
resp
iratory
tract,
-
excessive
seqetion,
-
bronchospasm.
Elofenal
is
intended
for
use
in:
-
s)'rnptomatic
treatment (cough
and
expectoration)
in
a
course
ofbronchitis
and
pneumonitis.
Attention:
this
treatment
can
not
delay the
establishment
of
treatrnent
w.ith
antibiotics,
if
such
need
proceeds.
2.
Before
you
take
Elofenal
Do
not
take Elofenal
in
case
of:
-
hlpersensitivity
(allergy)
to
fenspiride
or
to
any
of
the
other
ingredients
ofthe
medicine,
-
children
below
2
years
old.
Take
special
care
with
Elofenal,
because:
-
medicine
does
not
substitute
treatment
with
antibiotics.
Taking
other
medicines
Please
tell
your
doctor
or
pharmacist
if
you
have recently
taken
any other
medicines,
including
medicines
obtained
without
prescription-
Interactions
of
fenspiride
with
other
medicines
are
not
known.
Fenspiride
has
antihistaminic
effect, therefore
there
can
occur
in

Summary of Product characteristics

SUMMARY
OF PRODUCT
CIIARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
ELOFENAL
2mglml,
syrup
2.
QUALITATIVE
AI{D
QUANTITATIVE
COMPOSITION
1
ml of
synrp contains
2
mg fenspiride
hydrochloride
(Fenspiridi
hydrochloridurn).
Excipients,
including
sucrose,
glycerol,
methyl
parahydroxybenzoate,
propyl
parahydroxybenzoate.
For
a
fulI list
of
excipients,
see
section
6.1.
3.
PHARMACEUTICAL
F'ORM
Syrup.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic indications
Symptomatic treatrnent
(cough
and
expectoration)
in
a
course
ofbronchitis.
and
pneumonitis.
Attention:
this treafinent
can
not
delay the establishment
of
treatment
with
antibiotics,
if
such
need
proceeds.
4.2
Posologr
and
method
of
administration
Children
above
the
age
of
2
years
old:
4
mg
per
kg
ofbody
weight
per
day:
-
with
the
body
weight
below
10
kg:
from
10
ml
to
20
ml
of
synrp
(2
to
4
teaspoons
per
day),
-
with
the
body
weight
above
10
kg: from
30
ml
to
60
ml
of
synrp
(2
to
4 tablespoons
per
da9.
Adults: from
45
ml
to
90
ml
of
synrp
(3
to
6
tablespoons
per
day).
Medicine
for
oral
use.
One teaspoon
(5
ml)
contains
10
mg of fenspiride
hydrochloride
and 3
g
ofsucrose
(what
coostitutes 0,25 bread
units).
One
tablespoon
(15
ml)
contains
30
mg of
fenspiride
hydrochloride
and 9
g
ofsucrose
(what
constitutes
0,75 bread
units).
4.3
Contraindications
Hypersensitivity to
fenspiride
or
to
any
ofthe
excipients
of
the
medicinal
product.
Do
not
use
in
children
below
2
years
old.
4.4
Special
warnings
and
precautions
for
use
Elofenal
does
not
substitute
treatnoent
with
antibiotics.
Elofenal
contains
sucrose.
Patients
with
rare
hereditary
problems
of
fructose intolerance,
glucose-galactose
malabsorption
or the
sucrose-isomaltose
deficiency,
should
not
take
this
medicine.
5
ml
of
synrp contains
3
g
of
sucrose,
and
15
ml of
s1.rup
contains
9
g
ofsucrose.
It
should
be
taken
into
consideration
in
patients
with
diabetes.
Elofenal
contains
glycerol,
which
can
cause
headache,
gastric
disorders
and diarrhea.
Elofenal
contains
methyl
parahydroxybenzoate
and
propyl
parahydroxybenzoate,
which
can