Clenil Modulite 50 micrograms per metered dose Pressurised Inhalation Solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Beclometasone dipropionate

Verfügbar ab:

Chiesi Farmaceutici S.p.A.

ATC-Code:

R03BA; R03BA01

INN (Internationale Bezeichnung):

Beclometasone dipropionate

Dosierung:

50 microgram(s)

Darreichungsform:

Pressurised inhalation, solution

Therapiebereich:

Glucocorticoids; beclometasone

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2005-09-30

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR USER
CLENIL® MODULITE® 50 micrograms per metered dose pressurised
inhalation solution
CLENIL® MODULITE® 100 micrograms per metered dose pressurised
inhalation solution
CLENIL® MODULITE® 200 micrograms per metered dose pressurised
inhalation solution
CLENIL® MODULITE® 250 micrograms per metered dose pressurised
inhalation solution
beclometasone dipropionate
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 CLENIL MODULITE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CLENIL MODULITE
3.
HOW TO USE CLENIL MODULITE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLENIL MODULITE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Clenil Modulite is a pressurised inhalation solution used to help
PREVENT
the symptoms of mild,
moderate or severe asthma. The active ingredient, beclometasone
dipropionate, is one of a group of
medicines called corticosteroids which are often referred to simply as
steroids. Steroids have an
anti-
inflammatory action reducing the swelling and irritation in the walls
of the small air passages in the
lungs, and so ease breathing problems.
DO NOT USE CLENIL MODULITE:
•
if you are allergic to any of the ingredients of this medicine or to
any other medicines used to
treat asthma
•
TO TREAT A SUDDEN ATTACK OF BREATHLESSNESS
. It will not help. Use a quick-acting ‘reliever’ inhaler
for this purpose and carry it with you at all times.
WARNINGS AND PRECAUTIONS:
Talk to your doctor, pharmacist or nurse before using Cl

Fachinformation

Health Products Regulatory Authority
16 March 2023
CRN00D81L
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clenil Modulite 50 micrograms per metered dose Pressurised Inhalation
Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 50 micrograms of beclometasone
dipropionate.
Each metered dose contains 100 micrograms of beclometasone
dipropionate.
Each metered dose contains 200 micrograms of beclometasone
dipropionate.
Each metered dose contains 250 micrograms of beclometasone
dipropionate.
Excipient with known effect
Clenil Modulite 50 micrograms per metered dose contains 7.683 mg
ethanol.
Clenil Modulite 100 micrograms per metered dose contains 7.638 mg
ethanol.
Clenil Modulite 200 micrograms per metered dose contains 8.267 mg
ethanol.
Clenil Modulite 250 micrograms per metered dose contains 8.929 mg
ethanol.
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution.
The solution is clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe asthma requires regular medical assessment as death may occur.
Patients with severe asthma have constant symptoms
and frequent exacerbations, with limited physical capacity and Peak
Expiratory Flow (PEF) values below 60 % predicted at
baseline with greater than 30 % variability, usually not returning
entirely to normal after a bronchodilator. These patients will
require high dose inhaled or oral corticosteroid therapy. Sudden
worsening of symptoms, which may be potentially
life-threatening, may require increased corticosteroid dosage, which
should be administered under urgent medical supervision.
Clenil Moduilte is indicated for the prophylactic management of mild,
moderate, or severe asthma in:
Adults
_Mild asthma_ (PEF valves greater than 80 % predicted at baseline with
less than 20 % variability): Patients requiring intermittent
symptomatic bronchodilator asthma medication on a regular basis.
_Moderate asthma_ (PEF valves 60 % to 80 % predicted at baseline with
20 % to 30 % variability): Patients w