Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
30-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
30-01-2017
Public Assessment Report Public Assessment Report (PAR)
30-01-2017

Active ingredient:

Budesonide, formoterol

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol fumarate dihydrate

Therapeutic group:

Drugs for obstructive airway diseases,

Therapeutic area:

Asthma

Therapeutic indications:

Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

Product summary:

Revision: 1

Authorization status:

Withdrawn

Authorization date:

2014-11-19

Patient Information leaflet

                                40
B. PACKAGE LEAFLET
Medicinal product no longer authorised
41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. 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 Pharma B.V. is and what it is used for
(page 3)
2.
What you need to know before you use Budesonide/Formoterol Teva Pharma
B.V. (page 5)
3.
How to use Budesonide/Formoterol Teva Pharma B.V. (page 9)
4.
Possible side effects (page 18)
5.
How to store Budesonide/Formoterol Teva Pharma B.V. (page 21)
6.
Contents of the pack and other information (page 22)
1.
WHAT BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR
Budesonide/Formoterol Teva Pharma B.V. 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 PHARMA B.V. IS INDICATED FOR USE IN ADULTS
18 YEARS OF AGE AND OLDER
ONLY.
BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. IS NOT IND
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Budesonide/Formoterol Teva Pharma B.V. 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 Pharma B.V. is indicated in adults 18 years
of age and older only.
Asthma
_ _
Budesonide/Formoterol Teva Pharma B.V. 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years
of age and older only.
Budesonide/Formoterol Teva Pharma B.V. 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 Pharma B.V. is not intended for the initial
management of asthma.
Budesonide/Formoterol Teva Pharma B.V. is not an appropriate treatment
for the adult patient with only
mild asthma who is not adequately controlled with an inhaled
corticosteroid and 
                                
                                Read the complete document

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Active ingredient Budesonide, formoterol

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ATC code R03AK07

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Marketed by Teva Pharma B.V.

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INN (International Name) budesonide, formoterol fumarate dihydrate

budesonide, formoterol fumarate dihydrate

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Patient Information leaflet Patient Information leaflet Bulgarian 30-01-2017
Summary of Product characteristics Summary of Product characteristics Bulgarian 30-01-2017
Public Assessment Report Public Assessment Report Bulgarian 30-01-2017
Patient Information leaflet Patient Information leaflet Spanish 30-01-2017
Summary of Product characteristics Summary of Product characteristics Spanish 30-01-2017
Public Assessment Report Public Assessment Report Spanish 30-01-2017
Patient Information leaflet Patient Information leaflet Czech 30-01-2017
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Public Assessment Report Public Assessment Report Czech 30-01-2017
Patient Information leaflet Patient Information leaflet Danish 30-01-2017
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Public Assessment Report Public Assessment Report Danish 30-01-2017
Patient Information leaflet Patient Information leaflet German 30-01-2017
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Public Assessment Report Public Assessment Report German 30-01-2017
Patient Information leaflet Patient Information leaflet Estonian 30-01-2017
Summary of Product characteristics Summary of Product characteristics Estonian 30-01-2017
Public Assessment Report Public Assessment Report Estonian 30-01-2017
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Summary of Product characteristics Summary of Product characteristics Greek 30-01-2017
Public Assessment Report Public Assessment Report Greek 30-01-2017
Patient Information leaflet Patient Information leaflet French 30-01-2017
Summary of Product characteristics Summary of Product characteristics French 30-01-2017
Public Assessment Report Public Assessment Report French 30-01-2017
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Public Assessment Report Public Assessment Report Italian 30-01-2017
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Public Assessment Report Public Assessment Report Hungarian 30-01-2017
Patient Information leaflet Patient Information leaflet Maltese 30-01-2017
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Patient Information leaflet Patient Information leaflet Dutch 30-01-2017
Summary of Product characteristics Summary of Product characteristics Dutch 30-01-2017
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Patient Information leaflet Patient Information leaflet Polish 30-01-2017
Summary of Product characteristics Summary of Product characteristics Polish 30-01-2017
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Patient Information leaflet Patient Information leaflet Romanian 30-01-2017
Summary of Product characteristics Summary of Product characteristics Romanian 30-01-2017
Public Assessment Report Public Assessment Report Romanian 30-01-2017
Patient Information leaflet Patient Information leaflet Slovak 30-01-2017
Summary of Product characteristics Summary of Product characteristics Slovak 30-01-2017
Public Assessment Report Public Assessment Report Slovak 30-01-2017
Patient Information leaflet Patient Information leaflet Slovenian 30-01-2017
Summary of Product characteristics Summary of Product characteristics Slovenian 30-01-2017
Public Assessment Report Public Assessment Report Slovenian 30-01-2017
Patient Information leaflet Patient Information leaflet Finnish 30-01-2017
Summary of Product characteristics Summary of Product characteristics Finnish 30-01-2017
Public Assessment Report Public Assessment Report Finnish 30-01-2017
Patient Information leaflet Patient Information leaflet Swedish 30-01-2017
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Public Assessment Report Public Assessment Report Swedish 30-01-2017
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Patient Information leaflet Patient Information leaflet Icelandic 30-01-2017
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Patient Information leaflet Patient Information leaflet Croatian 30-01-2017
Summary of Product characteristics Summary of Product characteristics Croatian 30-01-2017
Public Assessment Report Public Assessment Report Croatian 30-01-2017

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