OTRIVIN MENTHOL

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

XYLOMETAZOLINE HYDROCHLORIDE

Fáanlegur frá:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC númer:

R01AA07

Lyfjaform:

SOLUTION

Samsetning:

XYLOMETAZOLINE HYDROCHLORIDE 0.1 %W/V

Stjórnsýsluleið:

NASAL

Gerð lyfseðils:

Not required

Framleitt af:

GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND

Meðferðarhópur:

XYLOMETAZOLINE

Lækningarsvæði:

XYLOMETAZOLINE

Ábendingar:

Nasal congestion in acute colds, vasomotor rhinitis, hay fever, rapid relief of nasal congestion for up to ten hours in adults and adolescents aged 12 years and older.

Leyfisdagur:

2023-01-31

Upplýsingar fylgiseðill

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS
’ REGULATIONS
)
PREPARATIONS
(
–
This edi
i
e is dispesed
ithout a do to ’s pes
iptio
OTII METHOL .%
/
IT A ASAL SOLUTIO
THE ATIE I
G EDIE T A D ITS O
E TATIO :
X lo
etazoli
e HCl .
%
/
Iatie i
g ediets ad alleges i
the p epaatio – please see se tio
ad setio
)
Ipo tat
i
fo
atio aout so
e i
g ediets of the
edi
i
e
(
.
READ THE ETIE LEAFLET A EFULL EFO E USI
G THE
EDI
I
E. This leaflet
o tai
s o
ise i
fo
atio
aout the edi
i
e. If
ou ha e a othe uestios, efe to the do to o the phaaist.
Use the p epaatio ao di
g to the i
stutio s i
the dosage se tio of this leaflet. Co sult the
phaaist if ou
eed o e i
fo
atio. Refe to the do to if sig s of the ail
e t
)
s
pto
s
(
o se o do ot i
p o e afte DA S.
.
WHAT IS THE
EDI
I
E I
TE DED FO ?
The
edi
i
e is i
teded fo apid elief of asal o gestio fo up to
hou s i
adults ad
adolesets o e
eas old.
Theapeuti
lass: Ot i
i
Methol o tai
s lo
etazoli
e h d o hlo ide,
hi
h elo gs to the
s
patho
i
eti agets g oup. It also o tai
s ethol ad eu al
ptus.
.
BEFO E USI
G THE
EDI
I
E
Do ot use this pepaatio if:
•
You ae sesiti e
)
alle gi
(
to the atie i
g ediet
)
lo
etazoli
e h d o hlo ide
(
o to a of
the othe
o
po ets the
edi
i
e
o tai
s
)
see setio
(
.
•
You ha e ao
agle glau o
a.
•
You ha e had a tas-spheoidal
)
ia the
asal a it
(
ese tio of the pituita
o a opeatio
du i
g hi
h the oute e i
ges of the
etal e ous s ste
as e posed.
•
You ha e h o i
asal i
fla
atio ith e d
asal passages
)
hi
itis si
a o atophi
hi
itis
(
.
•
Do ot use the pepaatio i
hild e ude the age of eas.
SPE IAL A
I
GS
EGA DI
G THE USE OF THE EDI
I
E:
BEFO E T EAT
ET ITH OT I
I ME THOL, I
FO THE DO TO IF:
•
You ha e high lood pessu e.
•
You ha e a heat disease o lo g QT s
d o
e.
•
You ha e a o eatie th
oid.
•
You ha e dia etes.
•
You ha e a elaged p ostate.
•
You ha e a
ae tuo i
the ad eal glad that p odu es e
ess ad eali
e ad
o ad eali
e
)
pheo ho
o
to
a
(
.
•
If ou ae taki
g ati-depessats, suh as:
-
Mo oai
e o idase i
hi
ito s
)
MAOIs
(
, do

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Otrivin Menthol 0.1% w/v, Nasal spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Otrivin Menthol 0.1%w/v metered-dose spray
Each ml of metered-dose spray contains 1 mg of xylometazoline
hydrochloride.
Excipients with known effect:
Benzalkonium chloride: 0.1 mg/ml.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nasal, solution.
Opalescent, w
h
ite solution, with an odor of menthol and eucalyptol.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Nasal congestion in acute colds, vasomotor rhinitis, hay fever, rapid
relief of nasal congestion
for up to ten hours in adults and adolescents aged 12 years and older.
4.2
Posology and method of administration
Otrivin Menthol should not be used in children aged less than 12 years
old.
Method of administration:
Otrivin nasal metered-dose spray
Age
Posology
Adults and adolescents over
12 years of age
1 spray into each nostril, 3 times daily as needed. Leave an
interval of 8 to 10 hours between doses. Do not exceed a
maximum of 3 applications daily into each nostril.
The metered-dose spray allows you to apply an exact dose and ensures
that the solution is
evenly distributed on the surface of the nasal mucosa. It prevents the
likelihood of an
unintentional overdose.
Each puff of Otrivin Menthol delivers 0.14 mL (0.14 mg of
xylometazoline hydrochloride).
Before first use, press the spray pump 4 times. Once full, the pump
will remain charged for the
period of regular daily use. If spraying does not occur when the pump
is fully pressed, or is not
used for more than 7 days, it must be refilled by pressing the pump 4
times as done before the
first use.
It is recommended to make the last application shortly before bedtime.
Be careful not to bring into contact
with your eyes.
1. Clear the nose gently.
2. Remove protective cap.
3. Do not cut the nozzle. The metered dose spray is ready to prime
before use.
4. Hold the bottle upright with thumb under base and nozzle between
two fingers.
5. Lean fo