Otrivine Congestion Relief Menthol 0.1% w/v Nasal Spray

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Xylometazoline hydrochloride

Tersedia dari:

Haleon Ireland Limited

Kode ATC:

R01AA; R01AA07

INN (Nama Internasional):

Xylometazoline hydrochloride

Dosis:

0.1 percent weight/volume

Bentuk farmasi:

Nasal spray, solution

Jenis Resep:

Product not subject to medical prescription

Area terapi:

Sympathomimetics, plain; xylometazoline

Status otorisasi:

Marketed

Tanggal Otorisasi:

2014-07-04

Selebaran informasi

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OTRIVINE CONGESTION RELIEF MENTHOL 0.1% W/V NASAL SPRAY
xylometazoline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without a prescription. However, you still
need to use Otrivine
Congestion Relief Menthol Nasal Spray 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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effect
not listed in this leaflet. See Section 4.
-
You must talk to a doctor if the symptoms worsen or do not improve
after 7 days.
IN THIS LEAFLET:
1.
What Otrivine Congestion Relief Menthol Nasal Spray is and what it is
used for
2.
What you need to know before you use Otrivine Congestion Relief
Menthol Nasal Spray
3.
How to use Otrivine Congestion Relief Menthol Nasal Spray
4.
Possible side effects
5.
How to store Otrivine Congestion Relief Menthol Nasal Spray
6.
Contents of the pack and other information
1.
WHAT OTRIVINE
CONGESTION RELIEF
MENTHOL
NASAL SPRAY IS AND WHAT IT IS USED FOR
Otrivine Congestion Relief Menthol Nasal Spray is for application in
the nose to give relief
from:
•
nasal congestion (blocked nose, including colds)
•
perennial and allergic rhinitis (recurring inflammation of the nasal
mucous membranes,
including hay fever)
•
sinusitis.
Otrivine Congestion Relief Menthol Nasal Spray contains the active
ingredient xylometazoline
hydrochloride which helps to open up and clear the nasal passages by
reducing the excessive
nasal secretions and returning the swollen blood vessels to their
normal size.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE CONGESTION RELIEF
MENTHOL
NASAL
SPRAY
DO NOT
use the spray if you:
-
are allergic to xylometazoline hydrochloride or any of the other
ingredients in the spray
(see Section 6).
Symptoms include: rash, swelling of

Karakteristik produk

Health Products Regulatory Authority
28 November 2023
CRN00DQ8Y
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Congestion Relief Menthol 0.1% w/v Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Otrivine Nasal Spray contains 1 mg/ml of xylometazoline hydrochloride.
Each metered-dose spray delivers 0.14 mg of xylometazoline
hydrochloride.
Excipients with known effect: polyoxyl hydrogenated castor oil (2.750
mg/ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray (solution)
Metered-dose spray: opalescent, white solution with menthol and
eucalyptol (cineole) odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of nasal congestion due to colds, hay fever or other
allergic rhinitis, sinusitis.
To aid drainage of secretions in affections of the paranasal sinuses.
As an adjuvant in otitis media, to decongest the nasopharyngeal
mucosa.
To facilitate rhinoscopy.
Otrivine Nasal Spray is indicated in adults and in adolescents over 12
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
_ _
Otrivine Nasal Spray should not be used in children aged less than 12
years old.
_ _
Method of administration
OTRIVINE NASAL SPRAY NASAL METERED-DOSE SPRAY
STRENGTH
AGE
POSOLOGY
0.1%
Adults and adolescents over 12 years of age
1 spray into each nostril, 3 times daily as needed. Do not exceed 3
applications daily into each nostril.
The metered-dose spray permits accuracy of dosage and ensures that the
solution is well distributed over the surface of the
nasal mucosa. It precludes the possibility of unintentional overdose.
Otrivine should not be used for more than seven consecutive days (see
section 4.4).
The recommended dosage should not be exceeded, especially in children
and the elderly.
Health Products Regulatory Authority
28 November 2023
CRN00DQ8Y
Page 2 of 5
Before the first application, prime the pump by actuating 4 times.
Once primed the pump will normally remain charged
throughout regular daily