Mometasone furoate 50 micrograms/actuation nasal spray, suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MOMETASONE FUROATE

Available from:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC code:

R01AD09

INN (International Name):

MOMETASONE FUROATE 50 µg

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

MOMETASONE FUROATE 50 µg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2014-01-22

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 Furoate nasal
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 breathing in
pollen from trees, grasses, weeds and also moulds and fungal spores.
Perennial rhinitis occurs
throughout the year and symptoms can be caused by a sensitivity to a
variety of things including
house dust mite, animal hair (or dander), feathers and

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
Page 2 of 10
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 each nostril once daily
(total dose 100 micrograms).
Mometasone furoate nasal spray, suspension demonstrated a clinically
significant onset of action
within 12 hours after the first dose in some patients with season