Xylonase 0.1 % w/v Nasal Spray, Solution

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

XYLOMETAZOLINE HYDROCHLORIDE

Հասանելի է:

Teva Pharma B.V.

ATC կոդը:

R01AA; R01AA07

INN (Միջազգային անվանումը):

XYLOMETAZOLINE HYDROCHLORIDE

Դոզան:

0.1 percent weight/volume

Դեղագործական ձեւ:

Nasal spray, solution

Ռեկվիզորի տեսակը:

Product not subject to medical prescription

Թերապեւտիկ տարածք:

Sympathomimetics, plain; xylometazoline

Լիազորման կարգավիճակը:

Not marketed

Հաստատման ամսաթիվը:

2012-08-17

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION
Xylometazoline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get 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 you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What
Xylonase 0.1% w/v Nasal Spray, Solution
is and what it is used for
2. What you need to know before you use
Xylonase 0.1% w/v Nasal Spray, Solution
3. How to use
Xylonase 0.1% w/v Nasal Spray, Solution
4. Possible side effects
5. How to store
Xylonase 0.1% w/v Nasal Spray, Solution
6. Contents of the pack and other information
1.
WHAT XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION IS AND WHAT IT IS USED
FOR
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
Xylonase 0.1% w/v Nasal Spray, Solution
contains the active ingredient xylometazoline, which is a topical
decongestant that relieves nasal congestion. A decongestant reduces
the swelling of the nasal mucosa.
Xylonase 0.1% w/v Nasal Spray, Solution
is used for temporary symptomatic treatment of nasal congestion due
to rhinitis or sinusitis.
XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION IS INTENDED FOR ADULTS AS WELL AS FOR CHILDREN 10 YEARS OF AGE AND
OLDER.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONASE 0.1% W/V NASAL SPRAY,
SOLUTION
DO NOT USE XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION

if you are allergic to xylometazoline or any of the other ingredients
of
this medicine
(listed in section 6).

if you have recently had neurosurgery (transsphenoidal hypophysectomy
or other surgery exposing the
meninx)

if you

Ապրանքի հատկությունները

Health Products Regulatory Authority
01 May 2019
CRN008XT0
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xylonase 0.1 % w/v Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One actuation (equivalent to 0.09 ml nasal spray, solution) contains
0.09 mg xylometazoline hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray).
Clear, almost colourless solution (pH 5.5-6; Osmolality 250-300
mOsm/kg).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For temporary symptomatic treatment of nasal congestion due to
rhinitis or sinusitis.
Xylonase 0.1% w/v Nasal Spray, Solution is intended for adults as well
as for children 10 years of age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
This medicinal product is intended for nasal use.
The dose in adults and children 10 years of age and older is 1-2
sprays of Xylonase 0.1% w/v Nasal Spray, Solution into each
nostril, according to need, but up to a MAXIMUM of 3 times daily.
Dosages higher than those recommended must not be used.
Xylonase 0.1% w/v Nasal Spray, Solution is suitable for adults as well
as for children over 10 years of age. It must not be used in
children below 10 years of age.
Paediatric population
Xylonase 0.1% w/v Nasal Spray, Solution is indicated in children aged
10 years and above to be administered as stated above.
Xylonase 0.1% w/v Nasal Spray, Solution should not be used in children
less than 10 years old. Other pharmaceutical strengths
may be more appropriate for administration to this population
Duration of use
Xylonase 0.1% w/v Nasal Spray, Solution must not be used for longer
than 7 days, unless prescribed by the clinician.
If after 3 days of treatment the patient feels no better or worse, the
clinical situation should be reevaluated. Long and excessive
use can cause reactive hyperaemia or rebound congestion respectively
(see section 4.4). The recommended dose should not be
exceeded.
An interval of several days should ela