Orbufox Easyhaler 160 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

budesonid; formoterolfumaratdihydrat

Disponible depuis:

Orion Corporation

Code ATC:

R03AK07

DCI (Dénomination commune internationale):

budesonide; formoterol

Dosage:

160 mikrogram/4,5 mikrogram/inhalation

forme pharmaceutique:

Inhalationspulver

Composition:

formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; budesonid 160 mikrog Aktiv substans

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

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

Statut de autorisation:

Godkänd

Date de l'autorisation:

2016-02-04

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORBUFOX EASYHALER, 160 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 Orbufox Easyhaler 160/4.5 is and what it is used for
2.
What you need to know before you use Orbufox Easyhaler 160/4.5
3.
How to use Orbufox Easyhaler 160/4.5
4.
Possible side effects
5.
How to store Orbufox Easyhaler 160/4.5
6.
Contents of the pack and other information
1.
WHAT ORBUFOX EASYHALER 160/4.5 IS AND WHAT IT IS USED FOR
Orbufox Easyhaler is an inhaler that is used to treat asthma in adults
aged 18 years and older. It is also
used to treat the symptoms of Chronic Obstructive Pulmonary Disease
(COPD) in adults aged 18 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ORBUFOX EASYHALER 160/4.5
DO NOT USE ORBUFOX EASYHALER 160/4.5:
-
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).

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orbufox Easyhaler, 160 micrograms/4.5 micrograms/inhalation,
inhalation powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
160 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 3800 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
Orbufox Easyhaler is indicated in adults 18 years of age and older
only.
ASTHMA
Orbufox Easyhaler 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.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Orbufox Easyhaler is indicated for the symptomatic treatment of
patients with COPD with FEV
1
< 70% predicted normal (post-bronchodilator) and an exacerbation
history despite regular
bronchodilator therapy (see also section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Orbufox Easyhaler is indicated in adults 18 years of age and older
only.
Orbufox Easyhaler is not indicated for use in children, 12 years of
age and younger or adolescents, 13
to 17 years of age.
2
ASTHMA
Orbufox Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Orbufox Easyhaler is individual and should be adjusted
to the severity of the disease.
This should b