Foradil Aerolizer, 12 microgram inhalation powder, hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FORMOTEROL

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

R03AC13

INN (International Name):

FORMOTEROL 12 µg

Pharmaceutical form:

INHALATION POWDER HARD CAPSULE

Composition:

FORMOTEROL 12 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2005-11-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FORADIL® AEROLIZER 12MCG INHALATION POWDER IN HARD CAPSULES
formoterol fumarate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep the leaflet. You may want to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
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 any of the side effects tell your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Foradil Aerolizer is, and what it is used for
2
What you need to know before you take Foradil Aerolizer
3
How to take Foradil Aerolizer
4
Possible side effects
5
How to store Foradil Aerolizer
6
Contents of the pack and other information
1 WHAT FORADIL AEROLIZER IS AND WHAT IT IS USED FOR
The Foradil Aerolizer pack includes a blister pack of capsules
containing the medicine and an
inhaler device for taking the medicine. Instructions for using the
inhaler are given later on in
the leaflet.
The active ingredient in this medicine is formoterol. Formoterol is
one of a group of
medicines called long-acting bronchodilators. It makes breathing
easier by relaxing muscle
spasms in the air passages of the lungs.
•
Foradil Aerolizer is used to treat asthma in people who are already
taking inhaled
steroids
but
still
have symptoms
such
as
wheezing
and
breathlessness.
Taking
Foradil
Aerolizer regularly together with inhaled steroids will help to
prevent breathing problems.
•
Foradil Aerolizer is also used to treat breathing problems in patients
with chronic
obstructive pulmonary disease (COPD).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FORADIL
DO NOT TAKE FORADIL
:
•
If you know you’re allergic to Foradil Aerolizer, or if you have
ever had an unusual or
allergic reaction to formoterol or inhaled lactose
•
If you are breastfeeding
•
If

Summary of Product characteristics

Novartis Pharma Services Inc
Malta
FORADIL
® AEROLIZER
®
(FORMOTEROL FUMARATE)
12 MICROGRAM INHALATION POWDER IN HARD CAPSULES
SUMMARY OF PRODUCT CHARACTERISTICS
Novartis
Page 2
Foradil® Aerolizer®
1. NAME OF THE MEDICINAL PRODUCT
FORADIL
AEROLIZER
,
12 microgram inhalation powder, hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 12 micrograms formoterol fumarate dihydrate (INN:
formoterol).
Excipient(s) with known effect
For a full list of excipients see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Inhalation powder, hard capsules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Prophylaxis and treatment of bronchoconstriction in patients with
asthma as an add-on
to
inhaled
corticosteroid
(ICS)
treatment
(see
section
4.4
Special
warnings
and
precautions for use).
•
Prophylaxis of bronchospasm induced by inhaled allergens, cold air, or
exercise.
•
Prophylaxis
and
treatment
of
bronchoconstriction
in
patients
with
reversible
or
irreversible
chronic
obstructive
pulmonary
disease
(COPD)
including
chronic
bronchitis and emphysema. Foradil has been shown to improve quality of
life in
COPD patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For inhalation use in adults and in children 5 years of age and older.
Foradil inhalation powder capsules should be used only with the
Aerolizer
®
device provided
in the Foradil pack.
There have been reports of patients who have mistakenly swallowed
Foradil capsules instead
of placing the capsules in the Aerolizer inhalation device. The
majority of these ingestions
were not associated with side effects. Healthcare providers should
discuss with the patient
how to correctly use Foradil Aerolizer (see section 4 Dosage and
administration subsection
method
of
administration).
If
a
patient
who
is
prescribed
Foradil
Aerolizer
does
not
experience breathing improvement, the healthcare provider should ask
how the patient is
using Foradil Aerolizer.
ADULTS
ASTHMA
For
regular
maintenance
therapy,
1
to
2
inhalation
capsules
(equivalent
to
1