Clenil Modulite 250micrograms/dose inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Beclometasone dipropionate

Available from:

Chiesi Ltd

ATC code:

R03BA01

INN (International Name):

Beclometasone dipropionate

Dosage:

250microgram/1dose

Pharmaceutical form:

Pressurised inhalation

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 03020000; GTIN: 5028613002438

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR USER
CLENIL
®
MODULITE
®
50 micrograms per actuation pressurised inhalation solution
CLENIL
®
MODULITE
®
100 micrograms per actuation pressurised inhalation solution
CLENIL
®
MODULITE
®
200 micrograms per actuation pressurised inhalation solution
CLENIL
®
MODULITE
®
250 micrograms per actuation 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 listedin 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 pressurised inhalation solution is 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 with

Summary of Product characteristics

OBJECT 1
CLENIL MODULITE 250 MICROGRAMS
Summary of Product Characteristics Updated 06-Apr-2017 | Chiesi
Limited
1. Name of the medicinal product
Clenil
R
Modulite
R
250 micrograms per actuation pressurised inhalation solution
2. Qualitative and quantitative composition
Beclometasone dipropionate 250 micrograms per metered (ex-valve) dose
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Pressurised inhalation solution
Clenil Modulite contains the new propellant HFA-134a and does not
contain any chlorofluorocarbons
(CFCs). The solution is clear and colourless.
4. Clinical particulars
4.1 Therapeutic indications
Clenil Modulite is indicated for the prophylactic management of mild,
moderate, or severe asthma in
adults or children:
_Mild asthma_: Patients requiring intermittent symptomatic
bronchodilator asthma medication on a regular
basis
_Moderate asthma_: Patients with unstable or worsening asthma despite
prophylactic therapy or
bronchodilator alone
_Severe asthma_: Patients with severe chronic asthma and those who are
dependent on systemic
corticosteroids for adequate control of symptoms
4.2 Posology and method of administration
Posology
Clenil Modulite is for inhalation use only. The Volumatic™ spacer
device may be used by patients who
have difficulty synchronising aerosol actuation with inspiration of
breath.
The starting dose of inhaled beclometasone dipropionate should be
adjusted to the severity of the disease.
The dose may then be adjusted until control is achieved and then
should be titrated to the lowest dose at
which effective control of asthma is maintained.
_Adults (including the elderly)_: Usually 1000 micrograms daily, which
may be increased to 2000
micrograms daily. This may then be reduced when the patient's asthma
has stabilised. The total daily
dosage should be administered as two to four divided doses.
The Volumatic™ spacer device must always be used when Clenil
Modulite is administered to adults and
adolescents 16 years of age and older taking total daily doses of 100