Symbicort mite Turbuhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

budesonid; formoterolfumaratdihydrat

Dostępny od:

Orifarm AB

Kod ATC:

R03AK07

INN (International Nazwa):

budesonide; formoterol

Dawkowanie:

80 mikrogram/4,5 mikrogram/inhalation

Forma farmaceutyczna:

Inhalationspulver

Skład:

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

Klasa:

Apotek

Typ recepty:

Receptbelagt

Dziedzina terapeutyczna:

Formoterol och budesonid

Podsumowanie produktu:

Förpacknings: Inhalator, 120 doser; Inhalator, 360 (3 x 120) doser

Status autoryzacji:

Avregistrerad

Data autoryzacji:

2005-09-28

Ulotka dla pacjenta

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT MITE TURBUHALER 80 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 Symbicort mite Turbuhaler is and what it is used for
2.
What you need to know before you use Symbicort mite Turbuhaler
3.
How to use Symbicort mite Turbuhaler
4.
Possible side effects
5.
How to store Symbicort mite Turbuhaler
6.
Contents of the pack and other information
1.
WHAT SYMBICORT MITE TURBUHALER IS AND WHAT IT IS USED FOR
Symbicort mite Turbuhaler 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. It can be
prescribed for asthma in two
different ways.
A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: SYMBICORT MITE
TURBUHALER AND A SEPARATE
‘RELIEVER INHALER’.

They use Symbicort mite Turbuhaler every day. This helps to prevent
asthma symptoms from
happening.
�

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Symbicort mite Turbuhaler, 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.
Each metered dose contains: budesonide 100 micrograms/inhalation and
formoterol fumarate dihydrate
6 micrograms/inhalation.
Excipient with known effect
Lactose monohydrate 810 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
Symbicort mite Turbuhaler is indicated in adults, adolescents, and
children aged 6 years and older.
Symbicort is indicated in 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:
Symbicort mite (80 micrograms/4.5 micrograms/inhalation) is not
appropriate in patients with severe
asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For inhalation use
Posology
Symbicort is not intended for the initial management of asthma.
The dosage of the components of Symbicort 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
adrenoceptor agonists and/or
corticosteroids by individual inhalers should be prescribed.
3
The dose should be titrated