Budesonide/Formoterol Teva

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

Budesonide, formoterol fumarate dihydrate

Tilgængelig fra:

Teva Pharma B.V.

ATC-kode:

R03AK07

INN (International Name):

budesonide, formoterol

Terapeutisk gruppe:

Drugs for obstructive airway diseases,

Terapeutisk område:

Pulmonary Disease, Chronic Obstructive; Asthma

Terapeutiske indikationer:

Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Produkt oversigt:

Revision: 2

Autorisation status:

Withdrawn

Autorisation dato:

2014-11-19

Indlægsseddel

43
B. PACKAGE LEAFLET
Medicinal product no longer authorised
44
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUDESONIDE/FORMOTEROL TEVA 160 MICROGRAMS/4.5 MICROGRAMS, 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Budesonide/Formoterol Teva is and what it is used for (page 3)
2.
What you need to know before you use Budesonide/Formoterol Teva (page
5)
3.
How to use Budesonide/Formoterol Teva (page 9)
4.
Possible side effects (page 18)
5.
How to store Budesonide/Formoterol Teva (page 21)
6.
Contents of the pack and other information (page 22)
1.
WHAT BUDESONIDE/FORMOTEROL TEVA IS AND WHAT IT IS USED FOR
Budesonide/Formoterol Teva contains two different active substances:
budesonide and formoterol fumarate
dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’ also known as ‘steroids’. It works
by reducing and preventing swelling and inflammation in your lungs and
helps you to breathe more
easily.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting β
2
adrenoceptor
agonists’ or ‘bronchodilators’. It works by relaxing the muscles
in your airways. This will help to open
the airways and help you to breathe more easily.
BUDESONIDE/FORMOTEROL TEVA IS INDICATED FOR USE IN ADULTS 18 YEARS OF
AGE AND OLDER ONLY.
BUDESONIDE/FORMOTEROL TEVA IS NOT INDICATED FOR USE IN CHILDREN 12
YEARS OF AGE AND YOUNGER OR
ADOLESCENTS 13 TO 17 YEARS OF AGE.
Your doctor has

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation
powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece of the
Spiromax) contains 160 micrograms of
budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
This is equivalent to a metered dose of 200 micrograms budesonide and
6 micrograms of formoterol
fumarate dihydrate.
Excipient(s) with known effect:
Each dose contains approximately 5 milligrams of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Inhalation powder.
White powder.
White inhaler with a semi-transparent wine red mouthpiece cover.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Budesonide/Formoterol Teva is indicated in adults 18 years of age and
older only.
Asthma
_ _
Budesonide/Formoterol Teva is indicated in the regular treatment of
asthma, where use of a combination
(inhaled corticosteroid and long-acting β
2
adrenoceptor agonist) is appropriate:
-in patients not adequately controlled with inhaled corticosteroids
and “as needed” inhaled short-acting β
2
adrenoceptor agonists.
or
-in patients already adequately controlled on both inhaled
corticosteroids and long-acting β
2
adrenoceptor
agonists.
COPD
_ _
Symptomatic treatment of patients with severe COPD (FEV
1
< 50% predicted normal) and a history of
repeated exacerbations, who have significant symptoms despite regular
therapy with long-acting
bronchodilators.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Budesonide/Formoterol Teva is indicated in adults 18 years of age and
older only.
Budesonide/Formoterol Teva is not indicated for use in children, 12
years of age and younger or adolescents,
13 to 17 years of age.
Medicinal product no longer authorised
3
Posology
_Asthma _
_ _
Budesonide/Formoterol Teva is not intended for the initial management
of asthma.
Budesonide/Formoterol Teva is not an