Asmanex Twisthaler 400 micrograms Inhalation Powder

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Mometasone furoate

থেকে পাওয়া:

Merck Sharp & Dohme Ireland (Human Health) Limited

এটিসি কোড:

R03BA; R03BA07

INN (আন্তর্জাতিক নাম):

Mometasone furoate

ডোজ:

400 microgram(s)

ফার্মাসিউটিকাল ফর্ম:

Inhalation Powder, Capsule

প্রেসক্রিপশন টাইপ:

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

থেরাপিউটিক এলাকা:

Glucocorticoids; mometasone

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2002-04-05

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASMANEX® TWISTHALER® 400 MICROGRAMS INHALATION POWDER
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, please 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 Asmanex Twisthaler is and what it is used for
2.
What you need to know before you use Asmanex Twisthaler
3.
How to use Asmanex Twisthaler
4.
Possible side effects
5.
How to store Asmanex Twisthaler
6.
Contents of the pack and other information
1.
WHAT ASMANEX TWISTHALER IS AND WHAT IT IS USED FOR
Asmanex Twisthaler contains the active substance mometasone furoate,
which belongs to a group of
medicines called corticosteroids or steroids as they are simply known.
Corticosteroids should not be confused with “anabolic” steroids
that are misused by some athletes.
Corticosteroids are used to prevent asthma attacks because they have
an anti-inflammatory effect.
They reduce swelling and irritation in the walls of the small air
passages in the lungs. This helps to
ease breathing problems.
Asmanex Twisthaler is used regularly to control asthma in adults and
adolescents, aged 12 years and
over. It can be used if you have not used a steroid before and your
asthma is not controlled by other
medicines. It can also be used if you have been taking a different
steroid either by mouth or by
inhalation, to control your asthma. Used regularly Asmanex Twisthaler
will help to control asthma and
prevent asthma attacks. It is a “preventor”. Do not use this
medicine for a sudden asthma attack. You
should always carry the bronchodilator (“reli

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
24 November 2020
CRN009VVD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asmanex Twisthaler 400 micrograms Inhalation Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose contains 400 micrograms of mometasone furoate.
Excipient(s) with known effect
The maximum recommended daily dose contains lactose 4.64 mg per day.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
White to off-white powder agglomerates.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asmanex Twisthaler 400 micrograms Inhalation Powder is indicated in
adults and adolescents 12 years of age and older for
regular treatment to control persistent asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Asmanex Twisthaler 400 micrograms Inhalation Powder should be
administered by oral inhalation only. After each dose,
patients should be advised to rinse their mouth with water and spit
out the contents without swallowing.
Posology
Dosage recommendations are based on severity of asthma (see criteria
below).
PATIENTS WITH PERSISTENT MILD TO MODERATE ASTHMA: The recommended
starting dose for most of these patients is
400 micrograms once daily. Data suggest that better asthma control is
achieved if once daily dosing is administered in the
evening. Some patients may be more adequately controlled on 400
micrograms daily, given in two divided doses
(200 micrograms twice daily). (A formulation of Asmanex Twisthaler 200
micrograms Inhalation Powder is also available.)
The dose of Asmanex Twisthaler 400 micrograms Inhalation Powder should
be individualised and titrated to the lowest dose at
which effective control of asthma is maintained. Dose reduction to 200
micrograms once daily given in the evening may be an
effective maintenance dose for some patients.
PATIENTS WITH SEVERE ASTHMA: The recommended starting dose is 400
micrograms twice daily, which is the maximum
recommended dose. When symptoms are controlled, titrate Asmanex
Twisthaler