FLIXOTIDE INHALER CFC FREE 50 MCG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

FLUTICASONE PROPIONATE

Beschikbaar vanaf:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-code:

R03BA05

farmaceutische vorm:

SUSPENSION FOR INHALATION

Samenstelling:

FLUTICASONE PROPIONATE 50 MCG/DOSE

Toedieningsweg:

INHALATION

Prescription-type:

Required

Geproduceerd door:

GLAXO WELLCOME SA, SPAIN

Therapeutische categorie:

GLUCOCORTICOIDS

Therapeutisch gebied:

FLUTICASONE

therapeutische indicaties:

Prophylactic management of all grades of asthma.Children aged 1 to 4 years:Inhaled fluticasone propionate is of benefit to young children in the control of persistent asthma

Autorisatie datum:

2014-08-31

Bijsluiter

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s prescription
only
Flixotide Inhaler CFC Free 50 mcg, Suspension for Inhalation
Each dose contains 50 micrograms of fluticasone propionate.
Flixotide Inhaler CFC Free 125 mcg, Suspension for Inhalation
Each dose contains 125 micrograms of fluticasone propionate.
Flixotide Inhaler CFC Free 250 mcg, Suspension for Inhalation
Each dose contains 250 micrograms of fluticasone propionate.
For the list of the inactive and allergenic ingredients in the
medicine, see section 6 –
"Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the
physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them
even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Flixotide Inhaler is used as a preventive treatment for asthma and for
treatment and
reduction of symptoms in chronic obstructive pulmonary disease (COPD)
when used in
combination with long acting bronchodilators.
Only the 250 mcg strength Flixotide Inhaler is suitable for the
treatment of COPD.
In children aged 1-4 years: Flixotide Inhaler 50 mcg is beneficial in
control of persistent
asthma symptoms.
Therapeutic group:
Corticosteroids
Flixotide Inhaler contains fluticasone propionate, which belongs to a
group of medicines
called corticosteroids (a group of synthetic hormones, often called
steroids). Flixotide
Inhaler works by reducing swelling and irritation in the lungs. It has
an anti-inflammatory
action. A very small dose is needed, as it is inhaled straight to the
lungs.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
you are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients contained in this medicine (as listed in section 6).
Spe

Productkenmerken

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
Flixotide Inhaler CFC Free 50 mcg
Flixotide Inhaler CFC Free 125 mcg
Flixotide Inhaler CFC Free 250 mcg
1.
NAME OF THE MEDICINAL PRODUCT
Flixotide Inhaler CFC Free 50 mcg
Flixotide Inhaler CFC Free 125 mcg
Flixotide Inhaler CFC Free 250 mcg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flixotide Inhaler CFC Free 50 mcg: Each metered dose contains 50
micrograms of fluticasone propionate.
Flixotide Inhaler CFC Free 125 mcg: Each metered dose contains 125
micrograms of fluticasone propionate.
Flixotide
Inhaler CFC Free 250 mcg: Each metered dose contains 250 micrograms of
fluticasone propionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for inhalation
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and actuator.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Flixotide inhaler 50, 125, 250 mcg are indicated for the prophylactic
management of all grades of asthma.
Flixotide inhaler 50 mcg is of benefit to young children aged 1 to 4
years in the control of persistent asthma
symptoms.
Flixotide inhaler 250 mcg is also indicated for the management of
chronic obstructive pulmonary disease
(COPD) when used in combination with long-acting bronchodilators (e.g.
long-acting beta agonists
(LABAs)).
4.2
Posology and Method of Administration
Flixotide Inhaler is for inhalation by oral inhalation only.
Page 2 of 13
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone propionate and
that it should be taken regularly even when they are asymptomatic. The
onset of therapeutic effect is 4 to 7
days, although some benefit may be apparent as soon as 24 hours for
patients who have not previously received
inhaled steroids.
The dosage of fluticasone propionate should be adjusted according to
the individual response.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they need more
inhalations than usual, medical attention must b