Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Budesonide, formoterol fumarate dihydrate

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; Pulmonary Disease, Chronic Obstructive

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:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) 

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2020-04-03

Patient Information leaflet

47
B. PACKAGE LEAFLET
48
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
2.
What you need to know before you use Budesonide/Formoterol Teva Pharma
B.V.
3.
How to use Budesonide/Formoterol Teva Pharma B.V.
4.
Possible side effects
5.
How to store Budesonide/Formoterol Teva Pharma B.V.
6.
Contents of the pack and other information
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 INDICATED FOR USE IN
CHILDREN 12 YEARS OF AGE
AND YOUNGER OR ADOLESCENTS 13 TO 17 YEARS OF AGE.
Your

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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.
COPD
_ _
Symptomatic treatment of patients with COPD with forced expiratory
volume in 1 second
(FEV
1
) < 70% predicted normal (post bronchodilator) and a history of
repeated exacerbations, who
have significant symptoms despite regular therapy with long-acting
bronchodilators.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 “as needed”
inhaled short-acting β