Formoterol 12 micrograms inhalation powder, hard capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Formoterol fumarate

Available from:

Laboratorios LICONSA, S.A.

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:

Not marketed

Authorization date:

2008-03-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FORMOTEROL 12 MICROGRAMS INHALATION POWDER, HARD CAPSULE
FORMOTEROL FUMARATE
WHAT IS IN THIS LEAFLET
1. What Formoterol is and what it is used for
2. What you need to know before you take Formoterol
3. How to take Formoterol
4. Possible side effects
5. How to store Formoterol
6. Contents of the pack and other information
1. WHAT FORMOTEROL IS AND WHAT IT IS USED FOR
Formoterol contains the active substance formoterol fumarate.
Formoterol is one of a group of medicines called selective
beta-2-adrenoreceptor agonists.
Formoterol is used for prevention of induced-exercise asthma,
treatment of symptoms of bronchial
asthma and other chronic obstructive reversible pulmonary diseases
such as coughing or breathing
difficulties and for symptomatic long-term treatment of bronchial
asthma in combination with a long-
term anti-inflammatory therapy (eg. Corticosteroids).
2.
WHAT YOU NEED TO KNOW
BEFORE YOUR TAKE FORMOTEROL
_ _
Follow carefully the instructions of your doctor or pharmacist even if
those are different from the
instructions given in this leaflet.
_DO NOT TAKE FORMOTEROL _
-
If you are allergic to formoterol, to beta 2 agonist general or to
lactose (which contains small amount
of milk proteins) or any of the other ingredients of this medicine
(listed in section 6).
_WARNING AND PRECAUTIONS FORMOTEROL _
Talk to your doctor or pharmacist before taking Formoterol
-
If you suffer from any heart problem: ischaemic heart disease (reduced
blood supply to the heart
muscle),
cardiac
arrhythmias
(abnormal
changes
in
heartbeat
frequency),
severe
heart
decompensation (defective cardiac filling and /or impaired contraction
and emptying), subvalvular
aortic stenosis (narrowing of aorta in the region under aortic valve),
hypertrophic obstructive
cardiomyopathy (thickness in the cardiac muscle that cause obstruction
of the outflow of blood),
aneurysm.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
-
Keep t

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2020
CRN00C0PN
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Formoterol 12 micrograms inhalation powder, hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 12 micrograms of formoterol fumarate (as
dihydrate).
Excipients with known effect: Lactose Monohydrate 23.99 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Transparent gelatin capsules containing white powder for inhalation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of bronchospasm as a result of exertion, symptomatic
treatment of bronchial asthma and other chronic obstruction
pulmonary diseases with a reversible component.
Symptomatic long-term treatment of bronchial asthma in combination
with a long-term antiinflammatory therapy (eg.
corticosteroids).
Note:
There are no indications to date that formoterol can replace treatment
with corticosteroids. In any case formoterol must be
combined with corticosteroids by inhalation in bronchial asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Capsules are only for inhalation.
Formoterol's bronchodilator effect is still significant 12 hours after
inhalation. Administration twice daily will therefore in most
cases be adequate to control bronchoconstriction associated with
chronic conditions, both during the day and at night.
Posology
Adults:
Symptomatic treatment of bronchial asthma and other chronic
obstructive pulmonary diseases with a reversible component.
Normal maintenance dose is 1 inhalation capsule (12 micrograms) twice
a day.
If it is necessary to relieve possible symptoms, a further 1-2
capsules per day may be used. The maximum daily dose is 4
capsules (48 micrograms).
The patient should be informed that if the extra dosage is necessary
more than twice a week, the doctor should be consulted
and treatment reassessed, as it is possible that the condition has
deteriorated.
Prophylaxis on exertion-induced bronchospasm or bef