Foradil 12microgram inhalation powder capsules with device

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Formoterol fumarate dihydrate

Disponível em:

Novartis Pharmaceuticals UK Ltd

Código ATC:

R03AC13

DCI (Denominação Comum Internacional):

Formoterol fumarate dihydrate

Dosagem:

12microgram

Forma farmacêutica:

Inhalation powder

Via de administração:

Inhalation

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 03010101; GTIN: 5010678906059

Folheto informativo - Bula

FORADIL
® 12 MICROGRAMS INHALATION POWDER, HARD CAPSULES
FORMOTEROL FUMARATE DIHYDRATE
PACKAGE LEAFLET: INFORMATION FOR THE USER AND INSTRUCTIONS FOR USE
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 only. 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.
Before you take Foradil
3.
How to take 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 an inhaler
device for taking the medicine. The capsules are for inhalation use
only. Instructions for
using the inhaler are given later on in the leaflet.
The active ingredient in this medicine is formoterol fumarate
dihydrate. Formoterol
fumarate dihydrate 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

Foradil is also used to treat breathing problems in patients with
chronic obstructive
pulmonary disease (COPD)
2. BEFORE YOU TAKE FORADIL DO NOT TAKE FORADIL IF:

you are allergic to formoterol fumarate dihydrate or any of the other
ingredients of
this medicine (listed in section 6).
Foradil is not suitable for children under six years of age.
TALK

Características técnicas

OBJECT 1
FORADIL
Summary of Product Characteristics Updated 17-Oct-2016 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Foradil
®
, 12 micrograms inhalation powder, hard capsule
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
Inhalation powder, hard capsule
4. Clinical particulars
4.1 Therapeutic indications
Foradil is indicated in asthma (including nocturnal asthma and
exercise-induced symptoms) for those
treated with inhaled corticosteroids who also require a long-acting
beta agonist in accordance with current
treatment guidelines.
Foradil is indicated for the relief of reversible airways obstruction
in patients with chronic obstructive
pulmonary disease (COPD) requiring long-term bronchodilatory therapy.
4.2 Posology and method of administration
POSOLOGY
For use in adults (including the elderly) and in children 6 years of
age and older
_ADULTS (INCLUDING THE ELDERLY)_
Asthma
Foradil should only be prescribed as an add-on to an inhaled
corticosteroid.
Regular maintenance therapy: 1 inhalation capsule (equivalent to 12
micrograms formoterol fumarate
dihydrate) to be inhaled twice daily. For more severe cases 2
inhalation capsules to be inhaled twice daily.
This dosing regimen provides symptomatic relief throughout day and
night. The recommended maximum
daily dose is 48 micrograms per day.
Foradil should not be used to relieve the acute symptoms of an asthma
attack. In the event of an acute
attack, a short-acting beta2-agonist should be used (see Section 4.4).
Chronic Obstructive Pulmonary Disease
For regular maintenance therapy, 1 inhalation capsule (equivalent to
12 micrograms formoterol fumarate
dihydrate) to be inhaled twice daily.
_CHILDREN AGED 6 YEARS AND ABOVE_
Asthma
Foradil should only be prescribed as an add-on to an inhaled
corticosteroid.
For regular maintena