Respimix Easyhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

budesonid; formoterolfumaratdihydrat

Tillgänglig från:

Orion Corporation

ATC-kod:

R03AK07

INN (International namn):

budesonide; formoterol

Dos:

80 mikrogram/4,5 mikrogram/inhalation

Läkemedelsform:

Inhalationspulver

Sammansättning:

laktosmonohydrat Hjälpämne; budesonid 80 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 120 doser; Inhalator, 120 doser med fodral; Inhalator, 180 (3 x 60) doser; Inhalator, 360 (3 x 120) doser

Bemyndigande status:

Godkänd

Tillstånd datum:

2017-08-25

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RESPIMIX EASYHALER, 80 MICROGRAMS/4.5 MICROGRAMS/INHALATION,
INHALATION POWDER
Budesonide/formoterol fumarate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Respimix Easyhaler 80/4.5 is and what it is used for
2.
What you need to know before you use Respimix Easyhaler 80/4.5
3.
How to use Respimix Easyhaler 80/4.5
4.
Possible side effects
5.
How to store Respimix Easyhaler 80/4.5
6.
Contents of the pack and other information
1.
WHAT RESPIMIX EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR
Respimix Easyhaler is an inhaler that is used to treat asthma in
adults, adolescents and children aged 6
years and older. It contains two different medicines: budesonide and
formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing and
preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting
beta
2
adrenoceptor agonists’ or ‘bronchodilators’. It works by
relaxing the muscles in your
airways. This helps you to breathe more easily.
This medicine is not suitable for people with severe asthma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RESPIMIX EASYHALER 80/4.5
DO NOT USE RESPIMIX EASYHALER 80/4.5:
-
if you are allergic to budesonide, formoterol or to the other
ingredient of this medicine (listed in
section 6) which is lactose (which contains small amounts of milk
protein).
WARNINGS AND PRECAUTIONS
Talk to y

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Respimix Easyhaler, 80 micrograms/4.5 micrograms/inhalation,
inhalation powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
80 micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
With the Easyhaler device the delivered dose (ex-actuator) contains
similar quantity of active
substance as the metered dose (ex-reservoir).
Excipients with known effect: Lactose monohydrate 4000 micrograms per
delivered dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder in a device metered inhaler (Easyhaler).
White to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Respimix Easyhaler 80 micrograms/4.5 micrograms/inhalation is
indicated in adults, adolescents and
children aged 6 years and older.
Respimix Easyhaler 80 micrograms/4.5 micrograms/inhalation is
indicated for the regular treatment of
asthma where use of a combination (inhaled corticosteroid and
long-acting β
2
adrenoceptor agonist) is
appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled
short-acting β
2
adrenoceptor agonists.
or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting β
2
adrenoceptor agonists.
NOTE:
Respimix Easyhaler 80 micrograms/4.5 micrograms/inhalation is not
appropriate in patients
with severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Respimix Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Respimix Easyhaler is individual and should be adjusted
to the severity of the disease.
This should be considered not only when treatment with combination
products is initiated but also
when the maintenance dose is adjusted. If an individual patient should
require a combination of doses
other than those available in the combination inhaler, appropriate
doses of β
2
adre