Assieme Turbuhaler 160 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Land: Zweden

Taal: Zweeds

Bron: Läkemedelsverket (Medical Products Agency)

Werkstoffen:

budesonid; formoterolfumaratdihydrat

Beschikbaar vanaf:

Orifarm AB

ATC-code:

R03AK07

INN (Algemene Internationale Benaming):

budesonide; formoterol

Dosering:

160 mikrogram/4,5 mikrogram/inhalation

farmaceutische vorm:

Inhalationspulver

Samenstelling:

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

klasse:

Apotek

Prescription-type:

Receptbelagt

Therapeutisch gebied:

Formoterol och budesonid

Autorisatie-status:

Avregistrerad

Autorisatie datum:

2007-11-16

Bijsluiter

1 PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDETTE 160 MICROGRAMS/4.5 MICROGRAMS/INHALATION, INHALATION POWDER
Budesonide/Formoterol fumarate dihydrate
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 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 Gardette is and what it is used for
2.
What you need to know before you use Gardette
3.
How to use Gardette
4.
Possible side effects
5.
How to store Gardette
6.
Contents of the pack and other information
1.
WHAT GARDETTE IS AND WHAT IT IS USED FOR
Gardette is an inhaler that is used to treat asthma in adults and
adolescents aged 12-17 years. 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.
ASTHMA
Gardette can be prescribed for asthma in two different ways.
A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: GARDETTE AND A
SEPARATE ‘RELIEVER INHALER’.

They use Gardette every day. This helps to prevent asthma symptoms
from happening.

They use their ‘reliever inhaler’ when they get asthma symptoms,
to make it easier to breathe

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
.
NAME OF THE MEDICINAL PRODUCT
Gardette, 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.
Each metered dose contains: budesonide 200 micrograms/inhalation and
formoterol fumarate dihydrate
6 micrograms/inhalation.
Excipient with known effect
Lactose monohydrate 730 micrograms per delivered dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Gardette is indicated in adults and adolescents (12 years and older)
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)
Gardette is indicated in adults, aged 18 years and older, for the
symptomatic treatment of patients with
COPD with forced expiratory volume in 1 second (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
Route of administration: For inhalation use
Posology
ASTHMA
Gardette is not intended for the initial management of asthma. The
dosage of the components of Gardette 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