OTRIVINE ADULT MUCUS RELIEF MENTHOL 0.1 %w/v Nasal Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

XYLOMETAZOLINE HYDROCHLORIDE

Available from:

Novartis Consumer Health UK Limited

INN (International Name):

XYLOMETAZOLINE HYDROCHLORIDE

Dosage:

0.1 %w/v

Pharmaceutical form:

Nasal Spray Solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

Recto
Pharma code 1482
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 Adult Mucus Relief 
Menthol 0.1% w/v 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.

– You must talk to a doctor if the symptoms worsen  
or do not improve after 7 days.
IN THIS LEAFLET:
1. What Otrivine Adult Mucus Relief Menthol 0.1%  
w/v Nasal Spray is and what it is used for
2. Before you use Otrivine Adult Mucus Relief Menthol 
0.1% w/v Nasal Spray
3. How to use Otrivine Adult Mucus Relief Menthol 0.1% 
w/v Nasal Spray
4. Possible side effects
5. How to store Otrivine Adult Mucus Relief Menthol 0.1% 
w/v Nasal Spray
6. Further information
1. WHAT OTRIVINE ADULT MUCUS RELIEF 
MENTHOL 0.1% W/V NASAL SPRAY  
IS AND WHAT IT IS USED FOR
Otrivine Adult Mucus Relief Menthol 0.1% w/v 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 Adult Mucus Relief Menthol 0.1% w/v Nasal Spray 
contains the active ingredient xylometazoline hydrochlo-
ride 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. BEFORE YOU USE OTRIVINE ADULT MUCUS 
RELIEF MENTHOL 0.1% W/V NASAL SPRAY
DO NOT use the spray if you:
•  are allergic to xylometazoline hydrochloride or any 
of the other ingredients in the spra

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Adult Mucus Relief Menthol 0.1%w/v Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Otrivine Adult Mucus Relief Menthol, 0.1% w/v 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 Adult Menthol Mucus Relief, 0.1% w/v 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 Adult Mucus Relief Menthol 0.1% w/v Nasal Spray should not be used in children aged less than 12 years old.
Method of administration
OTRIVINE OTRIVINE ADULT MUCUS RELIEF MENTHOL 0.1% W/V 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 08/07/2014_
_CRN 2114928_
_page number: 1_
The metered-dose spray permits accuracy of dosage and ensures that the solution is well