Oxis Turbuhaler 9 mikrogram/dos Inhalationspulver

Valsts: Zviedrija

Valoda: zviedru

Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)

Aktīvā sastāvdaļa:

formoterolfumaratdihydrat

Pieejams no:

Farmagon AS

ATĶ kods:

R03AC13

SNN (starptautisko nepatentēto nosaukumu):

formoterol

Deva:

9 mikrogram/dos

Zāļu forma:

Inhalationspulver

Kompozīcija:

formoterolfumaratdihydrat 9 mikrog Aktiv substans; laktosmonohydrat Hjälpämne

Receptes veids:

Receptbelagt

Ārstniecības joma:

Formoterol

Autorizācija statuss:

Avregistrerad

Autorizācija datums:

2011-07-13

Lietošanas instrukcija

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXIS TURBUHALER 9 MICROGRAMS PER DOSE INHALATION POWDER
(Formoterol fumarate dihydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Oxis Turbuhaler is and what it is used for
2.What you need to know before you use Oxis Turbuhaler
3.How to use Oxis Turbuhaler
4.Possible side effects
5.How to store Oxis Turbuhaler
6.Contents of the pack and other information
1. WHAT OXIS TURBUHALER IS AND WHAT IT IS USED FOR
Oxis Turbuhaler is an inhaler. It contains a medicine called
formoterol. This belongs to a group of
medicines called ‘long-acting beta-agonists’ or
‘bronchodilators’.
It works by relaxing the muscles in your airways. This helps you to
breathe more easily. It starts to
work within 1 to 3 minutes and the effects last up to 12 hours.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease
(COPD).
ASTHMA
Oxis Turbuhaler is used to treat asthma in adults, adolescents and
children 6 years and older.
For asthma, your doctor will prescribe two asthma inhalers: Oxis
Turbuhaler and a separate
‘corticosteroid’ inhaler. These should be used together.
•
Oxis Turbuhaler is used to help prevent asthma symptoms from
happening.
•
Some people also use Oxis Turbuhaler when they need extra doses for
relief of asthma symptoms,
to make it easier to breathe again.
•
Oxis Turbuhaler can also be used before exercise to prevent asthma
symptoms caused by exercise.
CHRONIC OBSTRUCTIVE PULMONARY D

Produkta apraksts

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxis Turbuhaler, 9 micrograms/dose, inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (i.e. the dose leaving the mouthpiece) from Oxis
Turbuhaler contains
9 micrograms formoterol fumarate dihydrate, which is derived from a
metered dose of 12 micrograms.
Excipient with known effect
Lactose monohydrate 891 micrograms per delivered dose. See section
4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxis Turbuhaler is indicated in adults, adolescents and children aged
6 years and older, as add on
therapy to maintenance treatment with inhaled corticosteroids, for the
relief of broncho-obstructive
symptoms and prevention of exercise-induced symptoms in patients with
asthma when adequate
treatment with corticosteroids is not sufficient.
Oxis Turbuhaler is also indicated in adults for the relief of
broncho-obstructive symptoms in patients
with chronic obstructive pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use of doses above those normally required by the individual patient
on more than 2 days per week is
a sign of suboptimal disease control and maintenance treatment should
be reassessed.
_Asthma:_
In asthma, Oxis Turbuhaler can be used once or twice daily (‘regular
dosage’), and as ‘relief
medication’ to relieve acute broncho-obstructive symptoms.
_Adults aged > 18 years:_
_Relief medication: _
1 inhalation for the relief of acute broncho-obstructive symptoms.
_Regular dosage_
: 1 inhalation once or twice daily. Some patients may need 2
inhalations once or twice
daily.
_Prevention of exercise-induced bronchoconstriction: _
1 inhalation before exercise.
2
The daily dose for regular use should not exceed 4 inhalations,
however occasionally up to a
maximum of 6 inhalations may be allowed within a 24-hour period. No
more than 3 inhalations
should be taken on any single occ