FLIXOTIDE DISKUS 250 MCG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FLUTICASONE PROPIONATE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

R03BA05

الشكل الصيدلاني:

POWDER FOR INHALATION

تركيب:

FLUTICASONE PROPIONATE 250 MCG

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO WELLCOME PRODUCTION, FRANCE

المجموعة العلاجية:

FLUTICASONE

المجال العلاجي:

FLUTICASONE

الخصائص العلاجية:

Prophylactic management of all grades of asthma.Fluticasone propionate is indicated for the management of COPD when used in combination with long-acting bronchodilators (e.g. long-acting beta agonists (LABAs)).

تاريخ الترخيص:

2021-01-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
−
1986
The medicine is dispensed according to a physician’s prescription
only
Flixotide Diskus 100 mcg, Powder for Inhalation
Each dose contains 100 microgram fluticasone propionate,
Flixotide Diskus 250 mcg, Powder for Inhalation
Each dose contains 250 microgram fluticasone propionate,
Flixotide Diskus 500 mcg, Powder for Inhalation
Each dose contains 500 microgram 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 Diskus 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 or 500 mcg strength Flixotide Diskus is suitable for
the
treatment of COPD.
Therapeutic group:
Corticosteroids
Flixotide Diskus contains fluticasone propionate, which belongs to a
group of
medicines called corticosteroids (a group of synthetic hormones, often
called
steroids). Flixotide Diskus works by reducing swelling and irritation
in the lungs.
It has an anti-inflammatory action.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
you are sensitive (allergic) to the active ingredient (fluticasone
propionate),
lactose (which contains milk protein) or to any of the additional
ingredients
contained in this medicine (as listed in section 6).
Special warnings regarding use of the medicine
Before the treatment with Flixotide Diskus, tell the physician if:
•
you have ever been treated for tuberculosis (T

خصائص المنتج

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