SALMETEROL+

FLUTICASONE
MECHANISM OF ACTION
SALMETEROL
SELECTIVE, LONG-ACTING BETA-ADRENERGIC RECEPTOR AGONIST. IT
INHIBITS THE RELEASE INTO THE LUNG OF MEDIATORS FROM MAST
CELLS, THUS INHIBITING THE RESPONSE TO THE INHALED ALLERGEN
AND ATTENUATING BRONCHIAL HYPERREACTIVITY.

FLUTICASONE
FLUTICASONE HAS ANTI-INFLAMMATORY, ANTIPRURITIC AND
VASOCONSTRICTIVE PROPERTIES. IN THE TREATMENT OF ASTHMA,
ALLERGIES, AND CHRONIC BRONCHIAL ASTHMA, GLUCOCORTICOIDS
REDUCE ALLERGIC RESPONSES FROM SEVERAL TYPES OF CELLS (E.G.,
MAST CELLS AND EOSINOPHILS) INVOLVED IN THE ALLERGIC
RESPONSE.

THERAPEUTIC INDICATIONS
SALMETEROL/FLUTICASONE
T T O . REGULAR A S T H M A I N C AS E O F I N S U F F I C I E N T
C O N TROL WITH I N H A L E D C O RT I C O S T E R O I D A N D
S H O RT-ACTING B 2 A G O N I S T "O N D E M A N D " O R
A D E QUATE CON T R O L W I T H L ON G - A C T I N G B 2
A G O NIST AND I N H A L E D C O R TI C O S T E R O I D .
E P O C WITH ESV < 6 0 % O F N O R M A L A N D H I S T O R Y
O F R EPEATED EX A C E R B A T I O N S T H A T S T I L L
P R E SENTS SIGNI F I C A N T S Y M P T O M S W I T H T T O .
R E G ULAR BRON C H O D I L A T O R .

INDICATIONS
INDICATIONS REGULAR LONG-TERM TREATMENT OF
REVERSIBLE AIRWAY OBSTRUCTION CAUSED BY ASTHMA (IN
COMBINATION WITH INHALED OR ORAL CORTICOSTEROIDS)
AND EPOC.

CONTRAINDICATIONS
HYPERSENSITIVITY TO FLUTICASONE, SALMETEROL OR
ANY OF THE EXCIPIENTS.
DO NOT ADMINISTER IN CHILDREN UNDER 4 YEARS.

QUALITATIVE AND QUANTITATIVE COMPOSITION

EACH INHALATION PROVIDES A DOSE RELEASED (THE DOSE
COMING OUT OF THE MOUTHPIECE) OF 47 MICROGRAMS OF S A L METEROL B A S E ( A S
SALMETEROL (AS SALMETEROL XINAFOATE) AND 92, 231 OR H Y D ROXYNAPHT H Y O A T E ) 5 0
460 MICROGRAMS OF FLUTICASONE PROPIONATE. THIS M C G 50 MCG 5 0 M C G
CORRESPONDS TO A PREDISPENDED DOSE OF 50 P R O PIONATO D E F L U T I C A S O NA
MICROGRAMS OF SALMETEROL (AS XINAFOATE FROM (M I C RONIZADO ) 1 0 0 M C G 2 5 0
SALMETEROL) AND 100, 250, OR 500 MICROGRAMS OF M C G 5 0 0 MCG
FLUTICASONE PROPIONATE. L A C TOSA MONO H I D R A T O … …
EXCIPIENT(S) WITH KNOWN EFFECT EACH DOSE RELEASED C . S . P. 1 2 , 5 MG 1 2 , 5 MG 1 2 , 5
CONTAINS UP TO 12.5 MILLIGRAMS OF LACTOSE
MG
(MONOHYDRATE).

PHARMACEUTICAL FORM
INHALATION POWDER (PRE-DISPENSED).
MOULDED PLASTIC DEVICE CONTAINING
AN ALUMINIUM STRIP WITH 28 OR 60
BLISTERS PLACED ON A REGULAR BASIS.

ADVERSE REACTIONS
B U C OPHARYNGE A L C A N D I D I AS I S , P N E U M O N I A ,
B R O NCHITIS; HY P O K A L E M I A ; H E A D A C H E ;
N A S OPHARYNGI T I S , T H R O A T I R R I T A T I O N ,
H O A RSENESS/D Y S P H O N I A , S IN U S I T I S ,
P A R ADOXICAL B R O N C H O S P A SM ; C O N T U S I O N S ;
M U S CLE CRAMP S , T R A U M A T I C F R A C T U R E S ,
A R T HRALGIA, MY A L G I A . C H I L D R E N , I N
A D D ITION: ANXI E T Y , S L E E P D I S O R D E R S ,
B E H AVIOR CHA N G E , I N C L U D I NG H Y P E R A C T I V I T Y
A N D IRRITABILI T Y .