Easyhaler Budesonide 100micrograms/dose dry powder inhaler

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Budesonide

Tilgængelig fra:

Orion Pharma (UK) Ltd

ATC-kode:

R03BA02

INN (International Name):

Budesonide

Dosering:

100microgram/1dose

Lægemiddelform:

Inhalation powder

Indgivelsesvej:

Inhalation

Klasse:

No Controlled Drug Status

Recept type:

Caution - AMP level prescribing advised

Produkt oversigt:

BNF: 03020000; GTIN: 6432100007926

Indlægsseddel

1
Scan this code or visit www.oeh.fi/uk to see instructions on how to
use Easyhaler
PACKAGE LEAFLET: INFORMATION FOR THE USER
EASYHALER BUDESONIDE 100 MICROGRAMS/DOSE
EASYHALER BUDESONIDE 200 MICORGRAMS/DOSE
EASYHALER BUDESONIDE 400 MICROGRAMS/DOSE
INHALATION POWDER
Budesonide
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 or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Easyhaler Budesonide is and what it is used for
2.
What you need to know before you use Easyhaler Budesonide
3.
How to use Easyhaler Budesonide
4.
Possible side effects
5.
How to store Easyhaler Budesonide
6.
Contents of the pack and other information
1.
WHAT EASYHALER BUDESONIDE IS AND WHAT IT IS USED FOR
The active ingredient in Easyhaler Budesonide is budesonide.
Budesonide powder is packed in an inhaler.
You inhale the powder into your lungs through the mouthpiece of the
inhaler. Budesonide works by reducing
and preventing swelling and inflammation in your lungs.
Easyhaler Budesonide is a medicine called “
PREVENTER
”. It is used to prevent symptoms of asthma. It belongs
to a group of medicines called corticosteroids.
Budesonide will NOT stop an asthma attack that has already started.
Therefore you always need to have a
fast acting bronchodilating “
RELIEVER”
(a beta
2
-agonist) with you.
The effect of budesonide may be noticeable after a few days treatments
but will only reach its maximum
after a few weeks. You should use Easyhaler Budesonide regularly to
prevent the asthmatic inflammation.
Go on taking this medicine regularly according to instructions,

Produktets egenskaber

OBJECT 1
EASYHALER BUDESONIDE 100 MCG
Summary of Product Characteristics Updated 06-Jul-2017 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Easyhaler Budesonide 100 micrograms/dose inhalation powder.
2. Qualitative and quantitative composition
One metered dose contains 100 micrograms of budesonide.
With the Easyhaler device the delivered dose (ex-actuator) contains
the same quantity of active substance
as the metered dose (ex-reservoir).
Excipient with known effect: Lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder.
White or almost white powder.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of mild, moderate, and severe persistent asthma.
(Note: Easyhaler Budesonide is not suitable for the treatment of acute
asthma attacks.)
4.2 Posology and method of administration
Posology
The therapeutic effect begins after a few days´ treatment and reaches
its maximum after some weeks of
treatment.
When transferring a patient to Easyhaler Budesonide from other
inhalation devices, the treatment should
be individualised. The previous active substance, dose regimen, and
method of delivery should be
considered.
The patients should be prescribed a starting dose of inhaled
budesonide which is appropriate for the
severity or level of control of their disease. The dose should be
adjusted until control is achieved and then
titrated to the lowest dose at which effective control of asthma is
maintained.
THE STARTING DOSE for adults (including the elderly and adolescents 12
to 17 years) with mild asthma
(Step 2) and for children 6 to 11 years of age is 200-400
micrograms/day. If needed, the dose can be
increased up to 800 micrograms/day. For adult patients with moderate
(Step 3) and severe (Step 4) asthma
the starting dose can be up to 1600 micrograms/day. The maintenance
dose should be adjusted to meet the
requirements of an individual patient taking into account the severity
of the disease and the clinical
response of the patient.
TWICE DAILY DOS