Momefin spray nasal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

mometasone (mometasone furoate)

Available from:

Biodeal Pharmaceuticals Pvt. Ltd.

ATC code:

R01AD09

INN (International Name):

mometasone (mometasone furoate)

Dosage:

50mcg/dose

Pharmaceutical form:

spray nasal

Units in package:

15ml plastic bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-11-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOMEFIN 50 MCG NASAL SPRAY
Mometasone Furoate
PLEASE READ 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. 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 Momefin is and what it is used for
2. What you need to know before you use Momefin
3. How to use Momefin
4. Possible side effects
5. How to store Momefin
6. Contents of the pack and other information
1. WHAT MOMEFIN IS AND WHAT IT IS USED FOR
WHAT IS MOMEFIN?
Momefin Nasal Spray contains mometasone furoate, one of a group of
medicines called
corticosteroids. 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.
THERAPEUTIC INDICATION
Hay fever and perennial rhinitis
Momefin is used to treat the symptoms of hay fever (also called
seasonal allergic rhinitis) and
perennial rhinitis in adults and children aged 3 and older.
Hay fever, 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 certain foods.
Momefin reduces the swelling and irritation in your nose and thereby
relieving sneezing,
itching and a blocked-up or runny nose caused by hay fever or
perennial rhinitis.
Nasal polyps
Momefin is used to treat nasal polyps in adults aged 18 and over.
Nasal polyps are small growt

Summary of Product characteristics

MODULE I : ADMINISTRATIVE INFORMATION
1.3
LABELLING AND PACKAGING
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
MOMEFIN
Mometasone Nasal Sprays 50 mcg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 GERNERAL DESCRIPTION
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITON
Composition:
Each spray delivers:
Mometasone Furoate Monohydrate
eq.to Mometasone Furoate…………….50 mcg
Benzalkonium Chloride Solution………0.02% w/v
Phenyl Ethyl alcohol………………….0.25% w/v
Excipients………………………………….. q.s.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICALS FORM
Nasal Spray
White to off white opaque suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
MOMEFIN is indicated for use in adults and children 3 years of age and
older to
treat the symptoms of seasonal allergic or perennial rhinitis.
MOMEFIN is indicated for the treatment of nasal polyps in adults 18
years of age
and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
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).
Momefin Nasal Spray demonstrated a clinically significant onset of
action within 12
hours after the first dose in some patients with seasonal allergic
rhinitis; however, full
MODULE I : ADMINISTRATIVE INFORMATION
1.3
LABELLING AND PACKAGING
benefit of