Asmanex 400micrograms/dose Twisthaler

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Mometasone furoate

Dostupné z:

Organon Pharma (UK) Ltd

ATC kód:

R03BA07

INN (Medzinárodný Name):

Mometasone furoate

Dávkovanie:

400microgram/1dose

Forma lieku:

Inhalation powder

Spôsob podávania:

Inhalation

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 03020000; GTIN: 5012376025780 5012376025797

Príbalový leták

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

Súhrn charakteristických

OBJECT 1
ASMANEX TWISTHALER 400 MICROGRAMS INHALATION
POWDER
Summary of Product Characteristics Updated 12-Dec-2017 | Merck Sharp &
Dohme Limited
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.
Excipients with known effect
The maximum recommended daily dose contains lactose 4.64 mg per day.
For the full list of excipients, see 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
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 400
micrograms Inhalation Powder to the lowest effective dose.
In patients with severe asthma and previously receiving oral
corticosteroids, Asmanex Twisthaler 400
micrograms Inhalation Pow