Clenil Modulite 50 micrograms per metered dose Pressurised Inhalation Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BECLOMETASONE DIPROPIONATE

Available from:

Chiesi Limited

ATC code:

R03BA; R03BA01

INN (International Name):

BECLOMETASONE DIPROPIONATE

Dosage:

50 microgram(s)

Pharmaceutical form:

Pressurised inhalation, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids; beclometasone

Authorization status:

Not marketed

Authorization date:

2005-09-30

Patient Information leaflet

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
1. WHAT CLENIL MODULITE IS AND WHAT IT IS USED FOR
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLENIL MODULITE
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

Summary of Product characteristics

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.
For a full list of excipients, see section 6.1.
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 with
unstable or worsening asthma despite prophylactic therapy or
bronchodilator alone.
_Severe asthma_ (PEF valves greater than 60 % predicted at baseline
with greater than 30 % variability): Patients with
severe chronic asthma and those who are dependent on systemic
corticosteroids for adequate control of symptoms.
Children
Any child who requires prophylactic asthma medication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Clenil Modulite is for oral inhalation use only.
A spacer device may be used with Clenil Modulite in patients who have
difficulty synchroni