SERETIDE EVOHALER 25125 mcg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FLUTICASONE PROPIONATE; SALMETEROL

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R03AK06

Dosage:

125 mcg

Pharmaceutical form:

AEROSOL, SPRAY

Composition:

FLUTICASONE PROPIONATE 125 mcg; SALMETEROL 25 mcg

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

GLAXO WELLCOME PRODUCTION

Authorization status:

ACTIVE

Authorization date:

2001-05-24

Patient Information leaflet

 
1 

SERETIDE
TM
 EVOHALER™ 
Salmeterol/fluticasone propionate 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each single actuation of Seretide provides: 
Salmeterol xinafoate  equivalent to 25
micrograms of salmeterol and 50, 125 or 250 
micrograms of fluticasone propionate. 
PHARMACEUTICAL FORM 
Inhalation aerosol. 
CLINICAL PARTICULARS 
INDICATIONS 
ASTHMA  
Seretide is indicated in the regular treatment of asthma where
use of a combination 
product (long-acting beta
2
-agonist and inhaled corticosteroid) is appropriate:  
-  Patients not adequately controlled with inhaled
corticosteroids and “as needed” 
inhaled short-acting-beta
2
-agonist 
or  
-  Patients already adequately controlled on both inhaled
corticosteroids and long-
acting-beta
2
-agonist 
Note: Seretide 25/50 mcg strength is not appropriate in
adults with severe asthma. 
DOSAGE AND ADMINISTRATION 
Seretide Evohaler is for oral inhalation only. 
Patients should be made
aware that Seretide Evohaler  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.  The dose should
be titrated to the lowest dose at which 
effective control of symptoms is maintained.  
Patients should be given the strength
of Seretide containing the appropriate fluticasone 
propionate dosage for the severity of their disease. 
Recommended Doses: 

2 

ASTHMA_ _
Adults and adolescents 12 years and older:- 
-  Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone
propionate twice 
daily. 
or 
-  Two inhalations of 25 mcg salmeterol and
125 mcg fluticasone propionate twice 
daily. 
or 
-  Two inhalations of 25 mcg salmeterol and
250 mcg fluticasone propionate twice 
daily. 
Children 4

Summary of Product characteristics

1
SERETIDE EVOHALER
Salmeterol/fluticasone propionate
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation of Seretide provides:
Salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 50,
125 or 250
micrograms of fluticasone propionate.
CLINICAL INFORMATION
INDICATIONS
Pharmaceutical form: Inhalation aerosol.
ASTHMA
Seretide is indicated in the regular treatment of asthma where use of
a combination
product (long-acting-beta
2
-agonist and inhaled corticosteroid) is appropriate:
-
Patients not adequately controlled with inhaled corticosteroids and
“as needed”
inhaled short-acting-beta
2
-agonist
or
-
Patients already adequately controlled on both inhaled corticosteroids
and long-
acting-beta
2
-agonist
Note: Seretide 25/50 mcg strength is not appropriate in adults with
severe asthma.
DOSAGE AND ADMINISTRATION
Seretide Evohaler is for oral inhalation only.
Patients should be made aware that Seretide Evohaler 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. The dose should be titrated to the lowest
dose at which
effective control of symptoms is maintained.
Patients should be given the strength of Seretide containing the
appropriate fluticasone
propionate dosage for the severity of their disease.
Recommended Doses:
2
ASTHMA
Adults and adolescents 12 years and older:
-
Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate
twice
daily.
or
-
Two inhalations of 25 mcg salmeterol and 125 mcg fluticasone
propionate twice
daily.
or
-
Two inhalations of 25 mcg salmeterol and 250 mcg fluticasone
propionate twice
daily.
Children 4 years and older:
-
Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate
twice
daily.
There are no data available for use of Seretide in children aged under
4 years.
Special patient groups:
There is no need to adjust the dose in elderly patients or in those
with ren