Otrivine Congestion 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:

1984-05-24

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OTRIVINE CONGESTION 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 Congestion
Relief 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.
-
You must contact a doctor if the symptoms worsen or do not improve
after 7 days.
-
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.
IN THIS LEAFLET
:
1.
What Otrivine Congestion Relief Nasal Spray is and what it is used for
2.
What you need to know before you use Otrivine Congestion Relief Nasal
Spray
3.
How to use Otrivine Congestion Relief Nasal Spray
4.
Possible side effects
5.
How to store Otrivine Congestion Relief Nasal Spray
6.
Contents of the pack and other information
1.
WHAT OTRIVINE CONGESTION RELIEF NASAL SPRAY IS AND WHAT IT IS USED FOR
Otrivine Congestion Relief 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 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 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 the face and throat, difficulty
breathing.
-
are taking, or have taken in the last two weeks, drugs for depression

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 Congestion Relief 0.1% w/v Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline Hydrochloride 0.1% w/v.
Excipients: Benzalkonium chloride 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray)
A clear, colourless 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 to 2 sprays 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 should not be used in children aged less than 12 years old.
ROUTE OF ADMINISTRATION: Nasal use.
1.
To produce a fine spray, the nebuliser should be held upright with the
nozzle pointing upwards. Be careful not to
spray in the eyes.
2.
Blow your nose gently.
3.
Remove protective cap.
4.
Lean forward slightly and insert the nozzle into a nostril.
5.
Squeeze the bottle once and breathe in gently at the same time.
6.
Remove the nozzle before releasing the pressure on the bottle.
7.
Repeat with the other nostril.
8.
Clean and dry the nozzle before replacing back the cap right after
use.
4.3 CONTRAINDICATIONS
Hypersensitivity to xylometazoline or to any of the excipients (see
list in section 6.1).
Health Products Regulatory Authority
28 November 2023
CRN00DQ8Y
Page 2 of 5
Otrivine should not be used in patients with trans-sphenoidal
hypophys