DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 160 MCG4.5 MCG

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Budesonide (micronised); Formoterol fumarate dihydrate (micronised)

Disponible depuis:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Code ATC:

R03AK07

forme pharmaceutique:

POWDER, METERED

Composition:

Budesonide (micronised) 160 mcg / inhalation; Formoterol fumarate dihydrate (micronised) 4.5 mcg / inhalation

Mode d'administration:

RESPIRATORY (INHALATION)

Type d'ordonnance:

Prescription Only

Fabriqué par:

Norton (Waterford) Limited

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2020-12-07

Notice patient

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

Résumé des caractéristiques du produit

1
NAME OF THE MEDICINAL PRODUCT
DuoResp
®
Spiromax
®
Dry powder for inhalation 160 mcg/4.5 mcg
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
ASTHMA
DuoResp Spiromax is indicated in the treatment of asthma to achieve
overall asthma
control, including the prevention and relief of symptoms as well as
the reduction of
the risk of exacerbations.
DuoResp Spiromax is indicated for treatment of asthma, where the use
of inhaled
corticosteroids is appropriate.
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
The dosage of DUORESP SPIROMAX should be individualised according to
disease
severity.
ASTHMA
DuoResp Siromax can be used according to different treatment
approaches:
A. DuoResp anti-inflammatory reliever therapy.
B. DuoResp anti-inflammatory reliever plus maintenance therapy.
As an alternative, DuoResp can be used in a fixed dose therapy:
C. DuoResp maintenance therapy.
DUORESP ANTI-INFLAMMATORY RELIEVER THERAPY (PATIENTS WITH MILD
DISEASE):
DuoResp is taken as needed for the relief of asthma symptoms when they
occur,
and to prevent allergen- or exercise- induced bronchoconstriction (or
to prevent
symptoms in those circumstances recognised