Arquist 125 microgram per actuation pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluticasone propionate

Available from:

Cipla Europe NV

ATC code:

R03BA; R03BA05

INN (International Name):

Fluticasone propionate

Dosage:

125 Mcg/Acutuation

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids; fluticasone

Authorization status:

Not marketed

Authorization date:

2017-01-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARQUIST 125 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
ARQUIST 250 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arquist is and what it is used for
2.
What you need to know before you use Arquist
3.
How to use Arquist
4.
Possible side effects
5.
How to store Arquist
6.
Contents of the pack and other information
1.
WHAT ARQUIST IS AND WHAT IT IS USED FOR
This medicine contains the active substance
_ _
fluticasone propionate which
_ _
belongs to a group of
medicines called corticosteroids. Arquist works by reducing swelling
and irritation in the lungs
inflammation in the lungs. Only a very small dose is needed as it is
inhaled straight to the lungs.
This has been prescribed by your doctor to treat either:
•
Asthma in adults and adolescents over 16 years of age or
•
Chronic Obstructive Pulmonary Disease (COPD) in adults only, when
given with other
medicines (long-acting beta agonist (such as salmeterol)) to open the
airways.
You must use Arquist every day as directed by your doctor, even if
there are no complaints.
This makes sure that it works properly in controlling your asthma or
COPD.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARQUIST
DO NOT USE ARQUIST
•
if you are allergic to
fluticasone propionate or any of the other ingredients of this
medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist o

Summary of Product characteristics

Health Products Regulatory Authority
27 April 2023
CRN00DF47
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arquist 125 microgram per actuation pressurised inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose (ex-valve) contains 125 micrograms of fluticasone
propionate. This is equivalent to a delivered dose
(ex-actuator) of 110 micrograms fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension (pressurised inhalation).
Arquist is a white homogeneous suspension, filled in an aluminum
container fitted with a suitable metering valve and a plastic
actuator. White coloured body with yellow cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arquist is indicated for the treatment of asthma in adults and
adolescents over 16 years of age. Arquist is also indicated for the
treatment of severe COPD in conjunction with a long-acting beta
agonist (such as salmeterol) for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Arquist is for inhalation by oral inhalation only.
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.
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.
It is intended that each prescribed dose is given by a minimum of 2
inhalations.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult a volumatic spacer may be used with Arquist
inhaler.
Posology
_Asthma_
The dosage of fluticasone propionate should be adjusted according to
the individual response.
_Adults and adolescents over 16 years of age_
100 to1000 micrograms twice daily.