Vylaer Spiromax

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

Therapeutic group:

Drugs for obstructive airway diseases,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive; Asthma

Therapeutic indications:

Vylaer Spiromax is indicated in adults 18 years of age and older only.AsthmaVylaer Spiromax 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.

Product summary:

Revision: 3

Authorization status:

Withdrawn

Authorization date:

2014-11-19

Patient Information leaflet

41
B. PACKAGE LEAFLET
Medicinal product no longer authorised
42
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VYLAER SPIROMAX 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 Vylaer Spiromax is and what it is used for (page 3)
2.
What you need to know before you use Vylaer Spiromax (page 5)
3.
How to use Vylaer Spiromax (page 9)
4.
Possible side effects (page 18)
5.
How to store Vylaer Spiromax (page 21)
6.
Contents of the pack and other information (page 22)
1.
WHAT VYLAER SPIROMAX IS AND WHAT IT IS USED FOR
Vylaer Spiromax 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.
VYLAER SPIROMAX IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND
OLDER ONLY.
VYLAER SPIROMAX IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF AGE
AND YOUNGER OR ADOLESCENTS 13 TO
17 YEARS OF AGE.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
ASTHMA
T

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Vylaer Spiromax 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
Vylaer Spiromax is indicated in adults 18 years of age and older only.
Asthma
_ _
Vylaer Spiromax 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.
Medicinal product no longer authorised
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vylaer Spiromax is indicated in adults 18 years of age and older only.
Vylaer Spiromax is not indicated for use in children, 12 years of age
and younger or adolescents, 13 to 17
years of age.
Posology
_Asthma _
_ _
Vylaer Spiromax is not intended for the initial management of asthma.
Vylaer Spiromax is not an appropriate treatment for the adult patient
with only mild asthma who is not