Fobumix Easyhaler 320micrograms/dose / 9micrograms/dose dry powder inhaler

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Budesonide; Formoterol fumarate dihydrate

Verfügbar ab:

Orion Pharma (UK) Ltd

ATC-Code:

R03AK07

INN (Internationale Bezeichnung):

Budesonide; Formoterol fumarate dihydrate

Dosierung:

400microgram/1dose ; 12microgram/1dose

Darreichungsform:

Inhalation powder

Verabreichungsweg:

Inhalation

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Caution - AMP level prescribing advised

Produktbesonderheiten:

BNF: 03020000; GTIN: 6432100030436

Gebrauchsinformation

1
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Scan this code or visit http://www.oeh.fi/bfgb to see instructions on
how to use Easyhaler
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOBUMIX EASYHALER 320 MICROGRAMS/ 9 MICROGRAMS, 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 Fobumix Easyhaler 320/9 is and what it is used for
2.
What you need to know before you use Fobumix Easyhaler 320/9
3.
How to use Fobumix Easyhaler 320/9
4.
Possible side effects
5.
How to store Fobumix Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT FOBUMIX EASYHALER 320/9 IS AND WHAT IT IS USED FOR
Fobumix 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.
Fobumix Easyhaler is indicated for use in adults 18 years of age and
older only.
Fobumix Easyhaler is NOT indicated for use in children 12 years of age
and younger or adolescents 13 to 17

Fachinformation

OBJECT 1
FOBUMIX EASYHALER 320 MICROGRAMS/ 9
MICROGRAMS, INHALATION POWDER
Summary of Product Characteristics Updated 02-Oct-2017 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Fobumix Easyhaler 320 micrograms/ 9 micrograms, Inhalation Powder.
2. Qualitative and quantitative composition
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 320
micrograms/inhalation and formoterol fumarate dihydrate 9
micrograms/inhalation.
With the Fobumix Easyhaler device the delivered dose (the dose that
leaves the mouthpiece) contains a
similar quantity of active substance as the metered dose.
Excipients with known effect: Lactose monohydrate 7600 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) which is
white with a red cap.
White to yellowish powder.
4. Clinical particulars
4.1 Therapeutic indications
Fobumix Easyhaler is indicated in adults 18 years of age and older
only.
ASTHMA
Fobumix Easyhaler 320 micrograms/ 9 micrograms 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)
Fobumix Easyhaler 320 micrograms/ 9 micrograms is indicated in adults,
aged 18 years and older, 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
Fobumix Easyhaler is indicated in adults 18 years of age and older
only.
Fobumix Easyhaler is not indicated for use in children, 12 years of
age and younger or