DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 320 MCG9 MCG

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Budesonide (micronised); Formoterol fumarate dihydrate (micronised)

Disponível em:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Código ATC:

R03AK07

Forma farmacêutica:

POWDER, METERED

Composição:

Budesonide (micronised) 320 mcg / inhalation; Formoterol fumarate dihydrate (micronised) 9 mcg / inhalation

Via de administração:

RESPIRATORY (INHALATION)

Tipo de prescrição:

Prescription Only

Fabricado por:

Norton (Waterford) Limited

Status de autorização:

ACTIVE

Data de autorização:

2020-12-07

Folheto informativo - Bula

2156
2156
131522_S1 - P: BUDESONIDE/FORMOTEROL, SG, DRY POWDER FOR INHALATION
160MCG/4.5MCG
03
10.11.2023
RB
04.12.2023
320 x 640
Norton (Waterford) Limited
8 pt
Profile
Black
PMS 375
PMS 696
SPEC. REFERENCE: MPSI092856
SAP CODE: PE3771V3
160 MCG/4,5 MCG
Dry powder for inhalation
BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE
PE3771V3
160 MCG/4.5 MCG
Dry powder for inhalation
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 DUORESP SPIROMAX IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUORESP
SPIROMAX
3. HOW TO USE DUORESP SPIROMAX
4. POSSIBLE SIDE EFFECTS
5.HOW TO STORE DUORESP SPIROMAX
6.CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DUORESP SPIROMAX IS AND WHAT
IT IS USED FOR
DuoResp 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.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
ASTHMA
DuoResp Spiromax can be prescribed for asthma i

Características técnicas

1
NAME OF THE MEDICINAL PRODUCT
DuoResp
®
Spiromax
®
Dry powder for inhalation 320 mcg/9 mcg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece of the
Spiromax)
contains 320 micrograms of budesonide and 9 micrograms of formoterol
fumarate dihydrate.
This is equivalent to a metered dose of 400 micrograms budesonide and
12 micrograms of formoterol fumarate dihydrate.
Excipient(s) with known effect:
Each dose contains approximately 10 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
ASTHMA
DuoResp 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.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symptomatic treatment of patients with COPD with FEV1 <70% predicted
normal (post-bronchodilator) and a history of repeated exacerbations,
despite regular long-acting bronchodilator therapy (see section
Special
warnings and precautions for use).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ASTHMA_
DuoResp Spiromax is not intended for the initial management of asthma.
The dosage of the components of DuoResp Spiromax is individual and
should
be adjusted to the severity of the disease. This should be considered
not
only when treatment with combination products is initiated but also
when
the maintenance dose is adjusted. If an individual patient should
require a
combination of doses other than those available in the combination
inhaler,
appropriate doses of β
2
-agonists and/or corticosteroid