FORADIL CAPSULES FOR INHALATION

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

FORMOTEROL FUMARATE DIHYDRATE

Disponible des:

NOVARTIS ISRAEL LTD

Codi ATC:

R03AC13

formulario farmacéutico:

POWDER FOR INHALATION

Composición:

FORMOTEROL FUMARATE DIHYDRATE 12 MCG

Vía de administración:

INHALATION

tipo de receta:

Required

Fabricat per:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Grupo terapéutico:

FORMOTEROL

Área terapéutica:

FORMOTEROL

indicaciones terapéuticas:

Foradil is indicated in asthma ( including nocturnal asthma and exercise-induced symptoms) in those treated with inhaled corticosteroids who also require a long-acting beta agonist in accordance with current treatment guidelines.Prophylaxis and treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Data d'autorització:

2021-07-31

Informació per a l'usuari

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Fitxa tècnica

FOR API APR21 V8
Ref: UK SmPC Dec2019
Business Use Only
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Foradil
®
capsules for inhalation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 12 micrograms formoterol fumarate dihydrate.
Excipient(s) with known effect:
Each capsule contains 25 mg lactose (as the monohydrate).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Powder For Inhalation, capsules
Clear capsules containing a white powder, with "GC” printed on cap
and "FXF" on body or
"FXF" on cap and "GC" on body in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Foradil is indicated in asthma (including nocturnal asthma and
exercise-induced symptoms) in
those treated with inhaled corticosteroids who also require a
long-acting beta agonist in
accordance with current treatment guidelines.
Prophylaxis and treatment of bronchoconstriction in patients with
chronic obstructive
pulmonary disease (COPD) including chronic bronchitis and emphysema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For use in adults and in children 6 years of age and older
_ _
_ADULTS _
Asthma
Foradil should only be prescribed as an add-on to an inhaled
corticosteroid.
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
(ICS).
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
FOR API APR21 V8
Ref: UK SmPC Dec2019
Business Use Only
frequent than 2 days per week) medical advice should be sought and
therapy reassessed, as
this may indicate a worsening of the underlying condition.
The recommended maximum maintenance dose is 48 micrograms per day.
Foradil should not be used to relieve the acute symptoms of an ast