Arquist 250 mikrogram/dos Inhalationsspray, suspension

Страна: Швеція

мова: шведська

Джерело: Läkemedelsverket (Medical Products Agency)

Активний інгредієнт:

flutikasonpropionat

Доступна з:

Cipla Europe NV

Код атс:

R03BA05

ІПН (Міжнародна Ім'я):

fluticasone propionate

Дозування:

250 mikrogram/dos

Фармацевтична форма:

Inhalationsspray, suspension

Склад:

flutikasonpropionat 250 mikrog Aktiv substans

Тип рецепту:

Receptbelagt

Огляд продуктів:

Förpacknings: Inhalator, 120 doser; Inhalator, 2 x 120 doser; Inhalator, 3 x 120 doser; Inhalator, 10 x 120 doser (sjukhusförpackning)

Статус Авторизація:

Godkänd

Дата Авторизація:

2016-12-22

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARQUIST 125 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
ARQUIST 250 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
fluticasone propionate
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arquist is and what it is used for
2.
What you need to know before you use Arquist
3.
How to use Arquist
4.
Possible side effects
5.
How to store Arquist
6.
Contents of the pack and other information
1.
WHAT ARQUIST IS AND WHAT IT IS USED FOR
This medicine contains the active substance fluticasone propionate
which belongs to a group of medicines
called corticosteroids. Arquist works by reducing inflammation in the
lungs. This helps to prevent asthma
attacks in people who need regular treatment. It takes 4-7 days for
this medicine to work and it is very
important that you use it regularly also when you do not have
symptoms.
Arquist is used for the regular treatment of asthma in adult and
adolescents over 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARQUIST
DO NOT USE ARQUIST
•
if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Stop using Arquist immediately
•
if you experience difficulty in breathing with immediate increase in
wheezing just after taking a dose of
this medicine.
In this case, immediately use a short-acting bronchodilator inhaler.
Talk to your doctor, pharmacist or nurse before using Arquist
•
if you

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Arquist 125 microgram per actuation pressurised inhalation, suspension
Arquist 250 microgram per actuation pressurised inhalation, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
metered
dose
(ex-valve)
contains
_ _
125
or
250
micrograms
of
fluticasone
propionate
respectively. This is equivalent to a delivered dose (ex-actuator) of
110 microgram or 227
microgram fluticasone propionate respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension
An inhaler comprising a fluorocarbon polymer treated aluminium alloy
canister, which is sealed
with a metering valve, actuator and dust cap.
4.
CLINICAL PARTICULARS
4.1THERAPEUTIC INDICATIONS
Arquist is indicated for the regular treatment of asthma.
Arquist is indicated in adult and adolescent patients over 12 years of
age.
4.2POSOLOGY AND METHOD OF ADMINISTRATION
Arquist is for oral inhalation use only.
Patients should be made aware Arquist should be taken regularly even
when they are asymptomatic.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they
need more inhalations than usual, medical attention must be sought.
_Adult and adolescent patients over 12 years of age: _
125 micrograms to 500 micrograms twice daily. The dose may be adjusted
until control is achieved
or reduced to the minimum effective dose, according to the individual
response. Where the control
of symptoms is maintained with the lowest strength of Arquist (125
microgram/actuation), the next
step could include a swap to a different inhaled fluticasone product
available in a lower strength
(50 micrograms/actuation). The onset of therapeutic effect is within 4
to 7 days.
For patients with severe asthma and during asthma exacerbations, as an
alternative to oral
corticosteroid therapy, a temporary increase in dose may be needed (up
to 2000 micrograms daily
in adult patients). The treatment effect should be monitored and fo