Otrivine Sinusitis Relief 0.1% w/v Nasal Spray, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Xylometazoline hydrochloride

Available from:

Haleon Ireland Limited

ATC code:

R01AA; R01AA07

INN (International Name):

Xylometazoline hydrochloride

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Nasal spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics, plain; xylometazoline

Authorization status:

Marketed

Authorization date:

1991-02-27

Patient Information leaflet

Page 1 of 4
Package leaflet: Information for the patient
Otrivine Sinusitis Relief 0.1% w/v Nasal Spray
Xylometazoline Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without a prescription. However, you still
need to use Otrivine Sinusitis Relief
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.
-
You must contact a doctor if the symptoms worsen or do not improve
after 7 days.
-
If any of the side effects get serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Otrivine Sinusitis Relief Spray is and what it is used for
2.
What you need to know before you use Otrivine Sinusitis Relief Spray
3.
How to use Otrivine Sinusitis Relief Spray
4.
Possible side effects
5.
How to store Otrivine Sinusitis Relief Spray
6.
Contents of the pack and other information
1.
WHAT
OTRIVINE SINUSITIS RELIEF SPRAY IS AND WHAT IT IS USED FOR
Otrivine Sinusitis Relief 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 Sinusitis Relief 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 SINUSITIS RELIEF SPRAY
DO NOT
use the spray if you:
-
are allergic to xylometazoline hydrochloride or any of the other
ingredients of the spray (see
section 6). Symptoms include: rash, swelling of the face and throat,
difficulty breathing.
-
If you are taking, or have taken in the last two weeks, drugs for
depression known as Monoamine
Oxidase Inhibitors (MAOIs)
-
have an overac

Summary of Product characteristics

Health Products Regulatory Authority
28 November 2023
CRN00DQ8Y
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Sinusitis Relief 0.1% w/v Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1mg xylometazoline hydrochloride
equivalent to 0.1 % w/v.
Excipients: Benzalkonium chloride 0.1mg/ml.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray).
A clear, colourless, virtually odourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a nasal decongestant for relief of the symptoms of acute rhinitis
in allergic or upper respiratory tract infections, including
the common cold or influenza. Relief of sinusitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Otrivine should not be used for more than seven consecutive days (see
section 4.4).
The recommended dose should not be exceeded, especially in children
and elderly.
ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS OVER 12 YEARS OF AGE:
1 spray into each nostril, up to 3 times daily as needed. Do not
exceed 3 applications daily into each nostril. It is recommended
to make the last application shortly before retiring to bed.
PAEDIATRIC POPULATION:
Otrivine Nasal Spray should not be used in aged less than 12 years
old.
Route of administration: Nasal use.
1.
Blow the nose gently.
2.
Remove protective cap.
3.
Do not cut the nozzle. The metered dose spray is ready to prime before
use.
4.
Before the first application, prime the pump by actuating (depressing
the pump) 4 times. Once primed the pump
will normally remain charged throughout regular daily treatment
periods. Should the spray not be ejected during
the full actuation, the pump will need to be re-primed by actuating 4
times. Be very careful not to spray in the eyes
or mouth.
5.
Hold the bottle upright with thumb under base and nozzle between two
fingers.
6.
Lean forward slightly and insert the nozzle into the nostril.
7.
Spray and breathe in gently through the nose at the same