MOMETASONE FUROATE 50 Mcg/Acutuation Nasal Spray Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MOMETASONE FUROATE MONOHYDRATE

Available from:

Cipla (EU) Limited

ATC code:

R01AD09

INN (International Name):

MOMETASONE FUROATE MONOHYDRATE

Dosage:

50 Mcg/Acutuation

Pharmaceutical form:

Nasal Spray Suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

corticosteroids

Authorization status:

Authorised

Authorization date:

2014-04-11

Patient Information leaflet

1

PACKAGE LEAFLET: INFORMATION FOR THE USER 

MOMETASONE FUROATE 50 MICROGRAMS/ACTUATION NASAL SPRAY, SUSPENSION 
(mometasone furoate as the monohydrate) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have further questions, ask your doctor or pharmacist. 
- 
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if 
their signs of illness are the same as yours. 
- 
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. 

WHAT IS IN THIS LEAFLET 
1. What Mometasone Furoate nasal spray, suspension is and
what it is used for 
2. What you need to know before
you use Mometasone Furoatenasal spray, suspension 
3. How to use Mometasone Furoate nasal spray, suspension 
4. Possible side effects 
5. How to store Mometasone Furoate nasal spray, suspension 
6. Contents of the pack and other information 

1. 
WHAT MOMETASONE FUROATE NASAL SPRAY, SUSPENSION IS AND WHAT
IT IS USED FOR 

Mometasone Furoate nasal spray, suspension contains the active
ingredient mometasone furoate (as the 
monohydrate). Mometasone furoate is a corticosteroid (steroid
for short) which has an anti-inflammatory 
action, reducing swelling and irritation which causes sneezing,
itching and a blocked or runny nose.  

WHAT IS MOMETASONE FUROATE NASAL SPRAY, SUSPENSION USED FOR? 

Hay fever and perennial rhinitis  
This medicine is used to treat the symptoms of hayfever (also called seasonal allergic rhinitis) and perennial 
rhinitis in adults and children aged 3 and older. 

Hayfever,  which  occurs  at  certain  times  of  the  year,  is  an  allergic  reaction  caused  by  br

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone furoate 50 micrograms/Actuation Nasal Spray Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation (100 mg) contains 50 micrograms of mometasone furoate (as the monohydrate) as delivered dose (ex
actuator).
Excipient with known effect:
This medicinal product contains 20 micrograms of benzalkonium chloride per actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
White to off-white coloured homogeneous re-dispersible suspension
with pH about 4.20 to 5 and osmolality 270-330
milliosmole / kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mometasone furoate nasal spray, suspension is indicated for use in adults and children 3 years of age and older to treat
the symptoms of seasonal allergic or perennial allergic rhinitis.
Mometasone furoate nasal spray, suspension is indicated for the treatment of nasal polyps in adults 18 years of age and
older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Seasonal Allergic or Perennial Rhinitis_
_Adults (including older patients) and children 12 years of age and older:_
The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200
micrograms). Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100
micrograms) may be effective for maintenance. If symptoms are inadequately controlled, the dose may be increased to
a maximum daily dose of four actuations in each nostril once daily (total dose 400 micrograms). Dose reduction is
recommended following control of symptoms.
_Paediatric population_
_Children between the ages of 3 and 11 years:_
The usual recommended dose is one actuation (50 micrograms/actuation) in e