Otrivin 0.05% Nasal Drops

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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资料单张 资料单张 (PIL)
28-06-2021
产品特点 产品特点 (SPC)
14-06-2021

有效成分:

XYLOMETAZOLINE HYDROCHLORIDE

可用日期:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN(国际名称):

XYLOMETAZOLINE HYDROCHLORIDE

每包单位数:

10ml mL

厂商:

GSK Consumer Healthcare SARL

资料单张

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OTRIVIN NASAL DROP
Xylometazoline hydrochloride (0.5mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What Otrivin Nasal Drop is used for
2.
How Otrivin Nasal Drop works
3.
Before you use Otrivin Nasal Drop
4.
How to use Nasal Drop
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
Otrivin
Nasal Drop
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT OTRIVIN NASAL DROP IS USED FOR
It is used for the relief of blocked nose
caused by colds, sinus or other allergic
conditions.
HOW OTRIVIN NASAL DROP WORKS
Xylometazoline
hydrochloride
helps
to
constricts the blood vessels around the
nose.
It
also
reduces
symptoms
of
excessive nasal secretions. This helps to
open up blocked nose and breathe more
easily through the nose.
BEFORE YOU USE OTRIVIN NASAL DROP
_- When you must not use it _
Do not use if:
•
you are allergic to xylometazoline or
any
other
ingredients
of
this
medicine,
•
you have undergone recent surgery
(through the nose or mouth),
•
you
have
narrow
angle
glaucoma
(increased pressure in eyes),
•
you
have
inflammatory
nasal
dryness,
•
you are pregnant.
_- Before you start to use it _
Do not use in children under 1 year old,
it is recommended for use in children
aged 1 to 11 years old only under adult
supervision.
Do not use before talking to your doctor
or pharmacist if any of the below apply:
•
you have high blood pressure,
•
you
suffer
from
a
heart
or
circulatory disease,
•
you
have
an
overactive
thyroid
gland,
•
you suffer from diabetes,
•
you have an enlarged prostate gland,
•
you
have
a
rare
tumour
of
the
adrenal
gland
(phaeochromocytoma),
•
you
are
breast-feeding,
Otrivin
Nasal Drop should only be used if
recommended by your doctor.
_- Taking other medicines _
Do not use before talking to your doctor
or pharmacist if you are taking certain
medicines
used
for
treatment
of
depression. These medicines are:
•
Monoamine
oxidase
inhibitors
(MAOI): do NOT use Otrivin Nasal
drop if you ar
                                
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产品特点

                                Pharma code 1722
SEA 941976 – 6 2000000026136
Pharma code 1722
NAME OF THE MEDICINAL PRODUCT
Otrivin 0.05% Nasal Drops
Otrivin 0.1% Nasal Spray
QUALITATIVE AND QUANTITATIVE COMPOSITION
Otrivin 0.05% nasal solution contains 0.5 mg/ml of xylometazoline
hydrochloride. Each drop delivers 0.0125 mg of xylometazoline
hydrochloride.
Otrivin 0.1% nasal solution contains 1 mg/ml of xylometazoline
hydrochloride.
For a full list of excipients, see section List of excipients.
PHARMACEUTICAL FORM
Clear, colourless and practically odourless solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Cold of various types. To aid drainage of secretions in sinus
conditions. In otitis media, as an adjuvant to decongest the
nasopharyngeal mucosa. To facilitate rhinoscopy.
POSOLOGY AND METHOD OF ADMINISTRATION
OTRIVIN 0.05% NASAL DROPS should not be used in children aged
less than 1 year old. It is recommended for use in children aged 1
to 11 years old only under adult supervision.
Children 1-5 years of age: With adult supervision. 1-2 drops into
each nostril once or twice daily (every 8 to 10 hours) are generally
sufficient. Do not exceed 3 applications daily into each
nostril.
Children 6-11 years of age: With adult supervision. 2 to 4 drops
into each nostril, 2 to 3 times daily as needed. Do not exceed 3
applications daily into each nostril.
Be careful not to administer in the eyes.
1. Clear the nose.
2. Tilt the head back as far as is comfortable or, if lying on a bed,
hang the head over the side.
3. Apply the drops into each nostril and keep the head tilted back
for a short time to allow the drops to spread throughout the nose.
4. Clean and dry the dropper before replacing it back into the bottle
right after use.
To avoid possible spread of infection, the bottle should only be
used by one person.
OTRIVIN 0.1% NASAL SPRAY should not be used in children aged less
than 12 years old.
Adults and adolescents over 12 years of age: 1 to 2 sprays into each
nostril, up to 3 times daily as needed. Do not exceed 3 applications
daily into each
                                
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资料单张 资料单张 马来文 28-06-2021