FOXAIR 50/100 ACCUHALER INHALER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GlaxoSmithKline South Africa (Pty) Limited

Dosage:

See ingredients

Pharmaceutical form:

INHALER

Composition:

EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 100,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug

Authorization status:

Registered

Authorization date:

2010-04-06

Patient Information leaflet

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
Type
Clinical
FOXAIR
25/50;
25/125;
25/250
INHALER
Implementation Date
pending
Category
Reg 10 notification
P
OWDER FOR INHALATION
(
SALMETEROL
/
FLUTICASONE PROPIONATE
)
Approval Date
26 Nov 2010
Reference
GDSv7
CTD
v0006
CONFIDENTIAL
1.3.2
PROPOSED PATIENT INFORMATION LEAFLET
_ _
Page 1 of 9
GDS-7
PATIENT INFORMATION LEAFLET
1
2
SCHEDULING STATUS:
3
S4
4
5
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL [DOSAGE] FORM:
6
FOXAIR 25/50 INHALER
7
FOXAIR 25/125 INHALER
8
FOXAIR 25/250 INHALER
9
Metered-dose inhaler
10
Salmeterol 50 µg and fluticasone propionate 100 µg, 250 µg or 500
µg
11
12
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING FOXAIR
INHALER.
13

Keep this leaflet. You may need to read it again.
14

If you have further questions, please ask your doctor or your
pharmacist.
15

FOXAIR has been prescribed for you or your child personally and should
not be shared
16
with other people. It may harm them, even if their symptoms are the
same as yours.
17
18
WHAT FOXAIR INHALER CONTAINS:
19
The active substances are salmeterol and fluticasone propionate
20
Each single actuation of FOXAIR INHALER provides:
21
Salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 50,
125 or 250
22
micrograms of fluticasone propionate.
23
The other ingredient is CFC-free propellant, HFA 134a.
24
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
Type
Clinical
FOXAIR
25/50;
25/125;
25/250
INHALER
Implementation Date
pending
Category
Reg 10 notification
P
OWDER FOR INHALATION
(
SALMETEROL
/
FLUTICASONE PROPIONATE
)
Approval Date
26 Nov 2010
Reference
GDSv7
CTD
v0006
CONFIDENTIAL
1.3.2
PROPOSED PATIENT INFORMATION LEAFLET
_ _
Page 2 of 9
GDS-7
25
WHAT FOXAIR INHALER IS USED FOR:
26
Your doctor has chosen this medicine to suit you and your condition.
FOXAIR INHALER is
27
used to help with asthma in people who need preventative treatment.
28
29
BEFORE YOU USE FOXAIR INHALER:
30
DO NOT USE FOXAIR:
31

if you are hype

Summary of Product characteristics

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
10 Dec 2015
Type
Clinical
FOXAIR
25/50;
25/125;
25/250
INHALER
Implementation Date
11 Dec 2015
Category
Reg 9 notification
P
OWDER FOR INHALATION
(
SALMETEROL
/
FLUTICASONE PROPIONATE
)
Approval Date
pending
Reference
GDSv7
CTD
v0006
CONFIDENTIAL
1.3 SOUTH AFRICAN LABELLING
1.3.1 SOUTH AFRICAN PACKAGE INSERT
1.3.1.1 PACKAGE INSERT
Page 1 of 11
GDS-7
SCHEDULING STATUS:
1
S4
2
3
PROPRIETARY NAME AND DOSAGE FORM:
4
FOXAIR 25/50 INHALER
5
FOXAIR 25/125 INHALER
6
FOXAIR 25/250 INHALER
7
Metered-dose inhaler
8
9
COMPOSITION:
10
Each single actuation of FOXAIR provides:
11
Salmeterol xinafoate equivalent to 25

g of salmeterol and 50, 125 or 250

g of fluticasone
12
propionate.
13
EXCIPIENT: Hydrofluoralkane 134a propellant (HFA 134a).
14
15
PHARMACOLOGICAL CLASSIFICATION:
16
A 21.5.4 Corticosteroids - Other combinations
17
18
PHARMACOLOGICAL ACTION:
19
PHARMACODYNAMIC PROPERTIES:
20
FOXAIR contains salmeterol and fluticasone propionate which have
differing modes of
21
action.
22
Salmeterol
is
a
selective
beta
2
-adrenoceptor
agonist.
Salmeterol
has
been
shown
to
23
produce long-lasting bronchodilatation of at least 12 hours in
subjects with reversible
24
airways obstruction. _ In vitro_ tests have shown salmeterol to be a
potent and long-lasting
25
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
10 Dec 2015
Type
Clinical
FOXAIR
25/50;
25/125;
25/250
INHALER
Implementation Date
11 Dec 2015
Category
Reg 9 notification
P
OWDER FOR INHALATION
(
SALMETEROL
/
FLUTICASONE PROPIONATE
)
Approval Date
pending
Reference
GDSv7
CTD
v0006
CONFIDENTIAL
1.3 SOUTH AFRICAN LABELLING
1.3.1 SOUTH AFRICAN PACKAGE INSERT
1.3.1.1 PACKAGE INSERT
Page 2 of 11
GDS-7
inhibitor of the release, from human lung, of mast cell derived
mediators, such as histamine,
26
leukotrienes and prostaglandin D
2
. In man salmeterol inhibits the early and late phase
27
response
to
inhaled
allergen
and
after
single
dosing
attenuates
bronchial
28
hyperresponsiveness.
29