BiResp Spiromax

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Budesonide, formoterol fumarate dihydrate

Διαθέσιμο από:

Teva Pharma B.V.

Φαρμακολογική κατηγορία (ATC):

R03AK07

INN (Διεθνής Όνομα):

budesonide, formoterol

Θεραπευτική ομάδα:

Drugs for obstructive airway diseases,

Θεραπευτική περιοχή:

Pulmonary Disease, Chronic Obstructive; Asthma

Θεραπευτικές ενδείξεις:

Asthma BiResp Spiromax is indicated in adults and adolescents (12 years and older) for 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.COPDBiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV₁)

Περίληψη προϊόντος:

Revision: 12

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-04-28

Φύλλο οδηγιών χρήσης

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BIRESP 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 BiResp Spiromax is and what it is used for
2.
What you need to know before you use BiResp Spiromax
3.
How to use BiResp Spiromax
4.
Possible side effects
5.
How to store BiResp Spiromax
6.
Contents of the pack and other information
1.
WHAT BIRESP SPIROMAX IS AND WHAT IT IS USED FOR
BiResp 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.
BIRESP SPIROMAX IS INDICATED FOR USE IN ADULTS AND ADOLESCENTS 12
YEARS OF AGE AND OLDER ONLY.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
ASTHMA
BiResp Spiromax can be prescribed for asthma in two different ways.
A) YOU MAY BE PRESCRIBED TWO ASTHMA INHALERS: BIRESP SPIROMAX TOGETHER
WITH A SEPARATE ‘RELIEVER
INHALER’ SUCH AS SALBUTAMOL.
•

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asthma
_ _
BiResp Spiromax is indicated in adults and adolescents (12 years and
older) for 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
_ _
BiResp Spiromax is indicated in adults, aged 18 years and older, for
the 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Asthma _
_ _
BiResp Spiromax is not intended for the initial management of asthma.
3
BiResp Spiromax is not an appropriate treatment for the adult or
adolescent patient with only mild asthma.
The dosage of BiResp Spiromax is individual and should be adjusted to
the severity of the disease. This
should be considered not only when treatment with combination
medicinal products is initiated but also
when the maintenance dose is ad