Otrivin 0.05% (Moisturising Formula)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

xylometazoline hydrochloride 0.05 % (w/v)

Available from:

Novartis Consumer Health UK Limited

ATC code:

R01AA07

INN (International Name):

xylometazoline hydrochloride

Pharmaceutical form:

nasal drops, solution

Authorization status:

Authorised

Authorization date:

2007-02-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

OTRIVIN 0.05% NASAL DROPS AND NASAL METERED-DOSE NASAL SPRAY  
xylometazoline hydrochloride 

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOUR CHILD. 
This medicine is available without prescription. However, you
still need to use Otrivin 0.05% 
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 your symptoms worsen or do not
improve. 

  If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET 
1

WHAT OTRIVIN 0.05% IS AND WHAT IT IS USED
FOR ............................................1

2

BEFORE YOU USE OTRIVIN
0.05% ...............................................................................2

3

HOW TO
USE OTRIVIN 0.05% ........................................................................................3

4

POSSIBLE SIDE
EFFECTS ...............................................................................................4

5

HOW TO STORE OTRIVIN
0.05% ...................................................................................5

6

FURTHER INFORMATION ..............................................................................................5

1 
WHAT OTRIVIN 0.05% IS AND WHAT IT IS USED FOR 
Otrivin 0.05% is indicated in children aged 1 to 11 years old. 
Otrivin 0.05% is a nasal decongestant that quickly clears blocked
noses.  
Otrivin 0.05% clears your child’s stuffy nose quickly so your child can breathe easier. It is used 
for the relief of blocked nose caused by colds, hay fever or
other allergic rhinitis, sinusitis.  
The effect of Otrivin 0.05% starts within minutes
and lasts�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 
OTRIVIN® 0.1% AND 0.05% (MOISTURISING FORMULA) 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Otrivin® 0.1% contains 1 mg/ml of xylometazoline hydrochloride. 
Otrivin® 0.05% contains 0.5
mg/ml of xylometazoline hydrochloride. 
3. 
PHARMACEUTICAL FORMS 
Nasal Drops, Solution and Nasal Spray, Solution (metered-dose spray)
0.1% F.5 
Nasal Drops, Solution and Nasal Spray, Solution (metered-dose spray)
0.05% F.5 
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. 
Otrivin 0.05% is indicated in children aged 1 to 11 years old. 
Otrivin 0.1% is indicated in adults and adolescents over 12 years
of age. 
4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 
Paediatric population: 
OTRIVIN  0.05%  should  not  be  used  in  children  aged  less  than  1  year  old.    It  is 
recommended  for  use  in  children  aged  1  to  11  years  old  only  under  adult 
supervision. 
OTRIVIN 0.1% should not be used in children aged less than 12 years
old. 
Method of administration: 
OTRIVIN NASAL DROPS 
STRENGTH 
AGE 
POSOLOGY 
0.05% 
Children  1  to  5  years 
of age 
With adult supervision. 
1 to 2 drops into each nostril once or twice 
daily  (every  8  to  10  hours)  are  generally 
sufficient.    Do  not  exceed  3  applications 
daily into each nostril. 
0.05% 
Children 6 to 11 years 
With adult supervision. 
of age 
2 to 4 drops into each nostril, 2 to 3 times 
daily.  Do not exceed 3 applications daily 
into each nostril. 
0.1% 

Adults 
and 
adolescents