SERETIDE 50100 ACCUHALER 50 mcg100 mcg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE EQV SALMETEROL

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R03AK06

Dosage:

100 mcg/inhalation

Pharmaceutical form:

POWDER, METERED

Composition:

FLUTICASONE PROPIONATE 100 mcg/inhalation; SALMETEROL XINAFOATE EQV SALMETEROL 50 mcg/inhalation

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline LLC

Authorization status:

ACTIVE

Authorization date:

1999-07-19

Patient Information leaflet

1 
SERETIDE
TM
 ACCUHALER
TM 
Salmeterol / fluticasone propionate 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Moulded plastic device containing a foil strip with 60
regularly placed blisters each 
containing 50 mcg of salmeterol (as salmeterol xinafoate) and
100 mcg of fluticasone 
propionate. 
Moulded plastic device containing a foil strip with 60
regularly placed blisters each 
containing 50 mcg of salmeterol (as salmeterol xinafoate) and
250 mcg of fluticasone 
propionate. 
Moulded plastic device containing a foil strip with 60
regularly placed blisters each 
containing 50 mcg of salmeterol (as salmeterol xinafoate) and
500 mcg of fluticasone 
propionate. 
PHARMACEUTICAL FORM 
Inhalation powder.  

CLINICAL PARTICULARS 

INDICATIONS 
Seretide is indicated in
the regular treatment of asthma where use of a combination 
(bronchodilator and inhaled corticosteroid) has been found to
be appropriate. 
Seretide is indicated for the symptomatic treatment
of patients with severe COPD (FEV1 
<50% predicted normal) and a history of repeated exacerbations,
who have significant 
symptoms despite regular bronchodilator therapy.   

DOSAGE AND ADMINISTRATION 
Seretide Accuhaler is for oral inhalation only. 
Patients should be made aware
that Seretide Accuhaler must be used regularly for 
optimum benefit, even when asymptomatic. 
Patients should be regularly reassessed by a doctor, so
that the strength of Seretide they 
are receiving remains optimal and is only changed on
medical advice.  
ASTHMA 
The dose should be titrated to the lowest dose at which
effective control of symptoms is 
maintained.  

2 
Patients should be given the strength
of Seretide containing the appropriate fluticasone 
propionate dosage for the severity of their disease. 
If a patient is inadequately controlled on inhaled corticosteroid
t

Summary of Product characteristics

1
SERETIDE ACCUHALER
Salmeterol / fluticasone propionate
QUALITATIVE AND QUANTITATIVE COMPOSITION
Moulded plastic device containing a foil strip with 60 regularly
placed blisters each
containing 50 mcg of salmeterol (as salmeterol xinafoate) and 100 mcg
of fluticasone
propionate.
Moulded plastic device containing a foil strip with 60 regularly
placed blisters each
containing 50 mcg of salmeterol (as salmeterol xinafoate) and 250 mcg
of fluticasone
propionate.
Moulded plastic device containing a foil strip with 60 regularly
placed blisters each
containing 50 mcg of salmeterol (as salmeterol xinafoate) and 500 mcg
of fluticasone
propionate.
CLINICAL INFORMATION
INDICATIONS
Pharmaceutical form: Inhalation powder.
Seretide is indicated in the regular treatment of asthma where use of
a combination
(bronchodilator and inhaled corticosteroid) has been found to be
appropriate.
Seretide is indicated for the symptomatic treatment of patients with
severe COPD (FEV
1
<50% predicted normal) and a history of repeated exacerbations, who
have significant
symptoms despite regular bronchodilator therapy.
DOSAGE AND ADMINISTRATION
Seretide Accuhaler is for oral inhalation only.
Patients should be made aware that Seretide Accuhaler must be used
regularly for
optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Seretide they
are receiving remains optimal and is only changed on medical advice.
ASTHMA
The dose should be titrated to the lowest dose at which effective
control of symptoms is
maintained.
2
Patients should be given the strength of Seretide containing the
appropriate fluticasone
propionate dosage for the severity of their disease.
If a patient is inadequately controlled on inhaled corticosteroid
therapy alone, substitution
with
Seretide
at
a
therapeutically
equivalent
corticosteroid
dose
may
result
in
an
improvement in asthma control.
Recommended Doses:
Adults and adolescents 12 years and older:
One inhalation (50 mcg salmeterol and 100 mcg fluticasone propiona