Gardette 160 mikrogram/4,5 mikrogram/inhalation Inhalationsspray, suspension

Nchi: Uswidi

Lugha: Kiswidi

Chanzo: Läkemedelsverket (Medical Products Agency)

Viambatanisho vya kazi:

budesonid; formoterolfumaratdihydrat

Inapatikana kutoka:

AstraZeneca AB

ATC kanuni:

R03AK07

INN (Jina la Kimataifa):

budesonide; formoterol

Kipimo:

160 mikrogram/4,5 mikrogram/inhalation

Dawa fomu:

Inhalationsspray, suspension

Tungo:

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

Dawa ya aina:

Receptbelagt

Bidhaa muhtasari:

Förpacknings: Inhalator, 120 doser

Idhini hali ya:

Godkänd

Idhini ya tarehe:

2016-02-18

Taarifa za kipeperushi

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDETTE 160 MICROGRAMS /4.5 MICROGRAMS/ACTUATION PRESSURISED
INHALATION, SUSPENSION
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 the symptoms of Chronic
Obstructive Pulmonary Disease (COPD)
in adults aged 18 and older. COPD is a long-term disease of the
airways in the lungs, which is often caused
by cigarette smoking. Gardette 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.
Do not use this medicine as a “reliever” inhaler.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GARDETTE
DO NOT USE GARDETTE:

if you are allergic to budesonide, formoterol or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using

Tabia za bidhaa

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
.
NAME OF THE MEDICINAL PRODUCT
Gardette, 160 micrograms/4.5 micrograms/actuation pressurised
inhalation, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (ex-actuator) contains: budesonide 160
micrograms/actuation and formoterol fumarate
dihydrate 4.5 micrograms/actuation.
This is equivalent to a metered dose containing budesonide 200
micrograms/actuation and formoterol
fumarate dihydrate 6 micrograms/actuation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
White suspension in an aluminium canister fitted into a red actuator
with a grey dust cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Gardette is indicated in adults, aged 18 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: Inhalation use.
COPD
_Recommended dose:_
_Adults:_
2 actuations twice daily.
GENERAL INFORMATION
_Special patient groups:_
There are no special dosing requirements for elderly patients. There
are no data available for use of Gardette
in patients with hepatic or renal impairment. As budesonide and
formoterol are primarily eliminated via
hepatic metabolism, an increased exposure can be expected in patients
with severe liver cirrhosis.
_Paediatric Population:_
There is no relevant use of Gardette 160 micrograms /4.5 micrograms in
children 11 years of age and under
or in adolescents 12 to 17 years of age in the symptomatic treatment
of COPD.
INSTRUCTIONS FOR THE CORRECT USE OF GARDETTE
On actuation of Gardette, a volume of the suspension is expelled from
the canister at high velocity. When the
patient inhales through the mouthpiece at the same time as actuating
the inhaler, the substance will