MOMETASONE FUROATE TEVA 50 Mcg/Acutuation Nasal Spray Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MOMETASONE FUROATE MONOHYDRATE

Available from:

Teva Pharma B.V.

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:

2014-01-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOMETASONE FUROATE TEVA 50 MICROGRAMS/ACTUATION NASAL SPRAY,
SUSPENSION
Mometasone Furoate
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 any 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 Teva Nasal Spray is and what it is used for
2.
What you need to know before you use Mometasone Furoate Teva Nasal
Spray
3.
How to use Mometasone Furoate Teva Nasal Spray
4.
Possible side effects
5.
How to store Mometasone Furoate Teva Nasal Spray
6.
Contents of the pack and other information
1.
WHAT MOMETASONE FUROATE TEVA NASAL SPRAY IS AND WHAT IT IS USED FOR
WHAT IS MOMETASONE FUROATE TEVA NASAL SPRAY?
Mometasone Furoate Teva 50 micrograms/actuation Nasal Spray,
Suspension contains mometasone furoate,
one of a group of medicines called corticosteroids. Mometasone furoate
should not be confused with
“anabolic” steroids misused by some athletes and taken as tablets
or injections. When mometasone furoate is
sprayed into the nose, it can help to relieve inflammation (swelling
and irritation of the nose), sneezing,
itching and a blocked up or runny nose.
WHAT IS MOMETASONE FUROATE TEVA NASAL SPRAY USED FOR?
Hayfever and perennial rhinitis
Mometasone Furoate Teva Nasal Spray 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 r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate Teva 50 micrograms/actuation Nasal Spray,
Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation (0.1 ml) of the pump delivers a metered dose of
50 micrograms mometasone furoate (as the
monohydrate). The total weight of one actuation is 100 mg.
Excipient with known effect: contains 20 micrograms benzalkonium
chloride per actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
White to off-white opaque suspension.
pH : between 4.3 and 4.9.
Osmolality: between 270 and 330 mOsm/Kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mometasone Furoate Nasal Spray is indicated for use in adults and
children 3 years of age and older to treat the
symptoms of seasonal allergic or perennial rhinitis.
Mometasone Furoate Nasal Spray is indicated for the treatment of nasal
polyps in adults aged 18 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
After initial priming of the Mometasone Furoate Nasal Spray pump, each
actuation delivers approximately 100 mg of
mometasone furoate suspension, containing mometasone furoate
monohydrate equivalent to 50 micrograms
mometasone furoate into each nostril.
POSOLOGY
Seasonal or Perennial Rhinitis
_Adults (including older patients) and children aged 12 years 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.
_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).
Mom