Nasomaris 0,5 mg/ml Neusspray, oplossing

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

XYLOMETAZOLINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,435 mg/ml

Beschikbaar vanaf:

Jadran Galenski laboratorij d.d. Svilno 20 51000 RIJEKA (KROATIË)

ATC-code:

R01AA07

INN (Algemene Internationale Benaming):

XYLOMETAZOLINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,435 mg/ml

farmaceutische vorm:

Neusspray, oplossing

Samenstelling:

KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340) ; WATER, GEZUIVERD ; ZEEWATER, GEZUIVERD,

Toedieningsweg:

Nasaal gebruik

Therapeutisch gebied:

Xylometazoline

Product samenvatting:

Hulpstoffen: KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340); WATER, GEZUIVERD; ZEEWATER, GEZUIVERD;

Autorisatie datum:

2012-09-04

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NASOMARIS 0,5 MG/ML NEUSSPRAY, OPLOSSING
Xylometazoline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD.
This medicine is available without prescription. However, your child
still needs to use
Nasomaris carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If your child gets any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

You must talk to a doctor if your child does not feel better or if the
child feels worse
after 3 days.
WHAT IS IN THIS LEAFLET:
1.
What Nasomaris is and what it is used for
2.
What you need to know before you use Nasomaris
3.
How to use Nasomaris
4.
Possible side effects
5.
How to store Nasomaris
6.
Contents of the pack and other information
1.
WHAT NASOMARIS IS AND WHAT IT IS USED FOR
The active ingredient in this medicine is xylometazoline. It
constricts blood vessels in the
nasal mucosa, thereby reducing its swelling due to various causes, and
makes breathing
through the nose easier.
Nasomaris is used for short-term treatment of nasal congestion in
children between 2 and
10 years old.
You must talk to a doctor if your child does not feel better or if the
child feels worse after
3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NASOMARIS
DO NOT USE NASOMARIS

if your child is allergic to xylometazoline or any of the other
ingredients of this
medicine (listed in section 6).

if your child has had recent brain surgery through the nose or mouth.
19.02.2019
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
if your child has a dry inflammation of the nasal mucous membrane with
formation of
crusts (rhinitis sicca).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Nasomaris if your child
has:

a tendency to hypersensitivity to sympathomimetics (dru

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nasomaris 0,5 mg/ml Neusspray, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of nasal spray contains 0.5 mg of xylometazoline hydrochloride.
1 dose (= 90 microlitres) contains 45 micrograms of xylometazoline
hydrochloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colourless solution.
pH 5.5 – 6.5, osmolality: 0.260 – 0.320 osmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion.
Nasomaris 0.5 mg/ml nasal spray may be used in children 2-10 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose in children between 2 and 10 years of age is 1 expression
into each nostril but no more than once
every 10-12 hours. If it should be necessary the medicinal product may
be used up to 3 times daily.
_PAEDIATRIC POPULATION_
Nasomaris 0.5 mg/ml nasal spray is indicated in children between 2 and
10 years to be administered as stated
below.
Nasomaris 0.5 mg/ml is not recommended to be taken by children under 2
years of age. The safety and
efficacy of Nasomaris 0.5 mg/ml in children younger than 2 years have
not yet been established.
The maximum treatment duration is 5 days, if after 3 days of treatment
the patient does not feel better or
feels worse, the clinical situation should be evaluated. Long and
excessive use can cause rebound congestion.
The recommended dose should not be exceeded.
Method of administration
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Before the first application it is necessary to spray a few times (4
times) in the air, to achieve a uniformity of
dose. The bottle should be in vertical position. If the product is not
used for several days at least one test
spray in the air should be done in order to achieve a uniform dose.
The products should be used after blowing one’s nose.
Nasomaris nasal spray is intended for intranasal use only. Nasal spray
should be delivered while seated. In
addition, small child