FLIXOTIDE NEBULES 2 MG2 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUTICASONE PROPIONATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

R03BA05

Pharmaceutical form:

INHALATION SUSPENSION FOR NEBULISATION

Composition:

FLUTICASONE PROPIONATE 2 MG / 2 ML

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE AUSTRALIA PTY LTD

Therapeutic group:

FLUTICASONE

Therapeutic area:

FLUTICASONE

Therapeutic indications:

In adults and adolescents over 16 years Flixotide Nebules can be used:For prophylactic management of severe chronic asthma in patients requiring high dose inhaled or oral corticosteroid therapy. It reduces symptoms and exacerbations of asthma in patients previously treated with other prophylactic therapy.

Authorization date:

2014-03-31

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
Flixotide Nebules 2 mg/2 ml,
Inhalation Suspension for Nebulisation
Each 2 ml of Flixotide Nebules contain 2 mg fluticasone propionate.
A list of the additional ingredients is detailed in section 6.
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 the pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them even if it seems to you that
their ailment
is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
In adults and adolescents over 16 years of age: For prophylactic
management
of severe chronic asthma in patients requiring high dose inhaled or
oral
corticosteroid therapy.
Therapeutic group: corticosteroids
Fluticasone propionate belongs to a group of medicines called
corticosteroids
(sometimes just called steroids). When taking steroids by inhalation,
a very low
dosage is required since the medicine goes straight to the lungs.
Flixotide Nebules reduces swelling and irritation in the lungs,
meaning, Flixotide
Nebules has an anti-inflammatory effect.
When Flixotide Nebules is used as a prophylactic therapy, it is very
important
to adhere to a daily treatment regimen.
Flixotide Nebules is not intended to treat sudden asthma attacks,
where you
feel breathless. There are other medicines to treat sudden attacks. If
you use
more than one medicine concomitantly, be careful not to confuse them.
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 the medicine, as detailed in section 6.
Do not use Flixotide Nebules if the above applies to you.
If you are not sure, refer to your physician or pharmacist before
using
Flixotide Nebules.
Special warnings reg

Summary of Product characteristics

Page 1 of 14
FLIXOTIDE NEBULES 2 MG/2 ML
1. NAME OF THE MEDICINAL PRODUCT
Flixotide
Nebules 2 mg/2 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plastic ampoules containing 2 ml of a buffered, isotonic saline
suspension
containing 2 mg fluticasone propionate.
3.
PHARMACEUTICAL FORM
Inhalation suspension for nebulisation.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_In adults and adolescents over 16 years Flixotide Nebules can be
used: _
For prophylactic management of severe chronic asthma in patients
requiring
high dose inhaled or oral corticosteroid therapy.
It reduces symptoms and exacerbations of asthma in patients previously
treated with other prophylactic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
If patients find that relief with short-acting bronchodilator
treatment becomes
less effective or they need more inhalations than usual, medical
attention must
be sought.
Page 2 of 14
Patients should be given an initial dose of nebulised fluticasone
propionate
which is appropriate for the severity of their disease. The dosage may
be
increased until control is achieved or reduced to the minimum
effective dose
according to the individual response.
_Adults and adolescents over 16 years_
: 500-2000 micrograms twice daily.
Prescribers should be aware that fluticasone propionate is as
effective as other
inhaled steroids approximately at half the microgram daily dose. For
example,
a 100 mcg of fluticasone propionate is approximately equivalent to 200
mcg
dose of beclometasone dipropionate (CFC containing) or budesonide.
Prescribers should be aware of the risks of systemic effects when
using high
doses of corticosteroids (see 4.4 special warnings and precautions for
use and
4.8 undesirable effects).
The dose should be titrated down to the lowest dose at which effective
control
of asthma is maintained.
_Children 16 years and under:_
Fl