Miflonide

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUDESONIDE

Available from:

Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom

ATC code:

R03BA02

INN (International Name):

BUDESONIDE 200 µg

Pharmaceutical form:

INHALATION POWDER

Composition:

BUDESONIDE 200 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2007-01-04

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIFLONIDE BREEZHALER 200 MICROGRAM INHALATION POWDER, HARD CAPSULE
MIFLONIDE BREEZHALER 400 MICROGRAM INHALATION POWDER, HARD CAPSULE
Budesonide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects affects you severely, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Miflonide is and what it is used for
2.
What you need to kno wbefore you use Miflonide Breezhaler
3.
How to use Miflonide Breezhaler
4.
Possible side effects
5.
How to store Miflonide Breezhaler
6.
Contents of the pack and other information
1.
WHAT MIFLONIDE BREEZHALER IS AND WHAT IT IS USED FOR
WHAT MIFLONIDE BREEZHALER IS
Miflonide Breezhaler is provided as a capsule to be put in an inhaler
called Miflonide Breezhaler
®
. The
inhaler opens the capsule and releases a dry powder that is delivered
to the lungs by breathing in.
Miflonide Breezhaler contains a substance called budesonide. It
belongs to a group of medicines called
“corticosteroids”. Some people call this their “steroid” or
“preventer” medicine.
WHAT MIFLONIDE BREEZHALER IS USED FOR

Long term (maintenance) treatment of asthma in adults and children 6
years of age and older

Chronic obstructive bronchitis (inflammation of the membrane lining
bronchial tubes, which
is part of the so called chronic obstructive pulmonary diseases, i.e.
COPD) in adults.
HOW MIFLONIDE BREEZHALER WORKS
Asthma is caused by inflammation of the small airways in your lungs,
which become swollen and make it
difficult to breathe.
Miflonide Breezhaler reduces and prevents the inflammation and
swelling of your airways, allowing you to
breathe more easily and reduce

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Miflonide Breezhaler 200 microgram inhalation powder, hard capsules
Miflonide Breezhaler 400 microgram inhalation powder, hard capsules_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 200 microgram capsule contains 230 micrograms of budesonide and
delivers 200 micrograms
of budesonide from the mouthpiece of the device when used in
conjunction with the (inhaler device
called) Miflonide Breezhaler.
Each 400 microgram capsule contains 460 micrograms of budesonide and
delivers 400 micrograms
of budesonide from the mouthpiece of the device when used in
conjunction with the (inhaler device
called) Miflonide Breezhaler.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule_. _
The 200 microgram capsule has a light pink opaque cap and a colourless
transparent body, printed
logo/BUDE 200.
The 400 microgram capsule has a pink opaque cap and a colourless
transparent body, printed
logo/BUDE 400.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BRONCHIAL ASTHMA
Miflonide is indicated in asthmatic patients aged 6 years and older
for:

Long term anti inflammatory control of persistent asthma including
prophylaxis of acute
exacerbations of asthma.
COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
Chronic obstructive bronchitis, in which corticosteroid therapy is
indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be carefully titrated individually to the minimum
effective dose to control
asthma symptoms.
The lowest dosage in a single capsule is 200 micrograms. If a single
dose of less than 200
micrograms is required, this product cannot be used. Miflonide is
contraindicated in children under
6 years of age (see section 4.3)
ADULTS:
Treatment of adults with mild asthma may be initiated at the minimum
effective dose of 200
micrograms once daily. Usual recommended dose is 200-1600 micrograms
divided in 2 doses. The
maintenance dose should be titrated to the lowest dose at which
effective cont