FORADIL CAPSULE FOR INHALATION 12 mcgcapsule

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FORMOTEROL FUMARATE

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

R03AC13

Dosage:

12 mcg/capsule

Pharmaceutical form:

POWDER, METERED

Composition:

FORMOTEROL FUMARATE 12 mcg/capsule

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

1996-02-05

Patient Information leaflet

FORADIL
 

Formoterol (Selective beta2-adrenergic agonist)  
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM 
Foradil inhalation powder, hard capsules. 
White free flowing powder in a clear hard gelation
capsule, marked ‘CG’ on the cap and 
‘FXF’ on the body or ‘CG’ on the body and ‘FXF’ on
the cap in black ink, size 3. 
Foradil inhalation powder capsules should be used only with the
Aerolizer
®
 device provided 
in the Foradil pack. 
ACTIVE SUBSTANCE 
One capsule contains 12 micrograms of formoterol fumarate
dihydrate (INN: formoterol). 
ACTIVE MOIETY 
Formoterol 
EXCIPIENTS 
Lactose monohydrate (25 mg/ capsule, which
contains milk proteins), gelatin. 
Pharmaceutical formulations may vary between countries. 
Box of 30 capsules, 10 capsules per blister pack. 
Information might differ in some countries  
INDICATIONS 
  Prophylaxis and treatment
of bronchoconstriction in patients with
asthma as an add-on to 
inhaled corticosteroid (ICS) treatment (see section
WARNINGS AND PRECAUTIONS). 
  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. 
DOSAGE AND ADMINISTRATION 
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
®
 inhaler provided 
in the Foradil pack. 
To ensure proper administration of the drug, a physician or other
health professional should: 
Novartis   Page 
2 
Country Specific Package Leaflet (Singapore)30 Jan 2012 
Foradil  

  Show the patient how to use the inhaler. 
  Dispense the capsule only

Summary of Product characteristics

Foradil Dec 2020.SIN
Page 1 of 19
FORADIL

Formoterol (Selective beta2-adrenergic agonist)
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Foradil inhalation powder, hard capsules.
White free flowing powder in a clear hard gelation capsule, marked
‘CG’ on the cap and
‘FXF’ on the body or ‘CG’ on the body and ‘FXF’ on the cap
in black ink, size 3.
Foradil inhalation powder capsules should be used only with the
Aerolizer
®
device provided
in the Foradil pack.
ACTIVE SUBSTANCE
One capsule contains 12 micrograms of formoterol fumarate dihydrate
(INN: formoterol).
EXCIPIENTS
Lactose monohydrate (25 mg/ capsule, which contains milk proteins) and
gelatin.
Pharmaceutical formulations may vary between countries.
Box of 30 capsules, 10 capsules per blister pack.
Information might differ in some countries
INDICATIONS
•
Prophylaxis and treatment of bronchoconstriction in patients with
asthma as an add-on to
inhaled corticosteroid (ICS) treatment (see section WARNINGS AND
PRECAUTIONS).
•
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.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ADULTS
ASTHMA
Foradil Dec 2020.SIN
Page 2 of 19
For
regular
maintenance
therapy,
1
to
2 inhalation
capsules
(equivalent
to
12
to
24 micrograms formoterol) twice daily. 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 daily maximum 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 shou