Foradil Aerolizer 12 microgram inhalation powder, hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Formoterol fumarate

Available from:

Novartis Ireland Limited

ATC code:

R03AC; R03AC13

INN (International Name):

Formoterol fumarate

Dosage:

12 microgram(s)

Pharmaceutical form:

Inhalation powder, hard capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; formoterol

Authorization status:

Marketed

Authorization date:

1996-01-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FORADIL
® AEROLIZER
®
12 MICROGRAM INHALATION POWDER, HARD CAPSULES
formoterol fumarate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
This medicine has been prescribed for you. 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Foradil is and what it is used for
2.
What you need to know before you use Foradil
3.
How to use Foradil
4.
Possible side effects
5.
How to store Foradil
6.
Contents of the pack and other information
1.
WHAT FORADIL IS AND WHAT IT IS USED FOR
The Foradil pack includes a blister pack of capsules containing the
medicine and a special inhaler
device called an Aerolizer for taking the medicine. Instructions for
using the inhaler are given later on
in the leaflet. The active substance in this medicine is formoterol
fumarate dihydrate. This 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 IS USED
•
to treat asthma in people who are already taking inhaled steroids but
still have symptoms such
as wheezing and breathlessness. Taking Foradil regularly together with
inhaled steroids will help to
prevent breathing problems.
•
for the prevention of breathing problems brought on by exercise, cold
air or breathing in
something that you are allergic to
•
to treat breathing problems in patients with chronic obstructive
pulmonary disease (COPD),
chronic bronchitis and emphysema.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FORADIL
DO NOT USE FORADIL
• if you are allergic (hypersensitive) to formoterol or to lactose
(

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2022
CRN00CTMQ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Foradil Aerolizer 12 microgram inhalation powder, hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 12 micrograms formoterol fumarate dihydrate.
Excipient(s) with known effect
Each capsule contains 25 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Colourless and transparent with the markings “CG” on one part and
“FXF” on the other part of the capsule.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For inhalation use in adults and in children 6 years of age and older.
_ADULTS_
Asthma
For regular maintenance therapy, 1 to 2 inhalation capsules
(equivalent to 12 to 24 micrograms formoterol) twice daily, in the
morning and the evening. Foradil should only be prescribed as an
add-on to an inhaled corticosteroid.
The maximum recommended maintenance dose is 48 micrograms per day.
If required, an additional 1 to 2 capsules per day may be used for the
relief of ordinary symptoms provided the recommended
maximum daily dose of 48 micrograms per day is not exceeded. However,
if the need for additional doses is more than
occasional (e.g. more frequent than 2 days per week) medical advice
should be sought and therapy reassessed, as this may
indicate a worsening of the underlying condition. Foradil should not
be used to relieve the acute symptoms of an asthma
at