Giona Easyhaler 100 micrograms/dose inhalation powder

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

BUDESONIDE

Saadav alates:

Orion Corporation Orionintie 1, FI-02200 Espoo, Finland

ATC kood:

R03BA02

INN (Rahvusvaheline Nimetus):

BUDESONIDE 100 µg

Ravimvorm:

INHALATION POWDER

Koostis:

BUDESONIDE 100 µg

Retsepti tüüp:

POM

Terapeutiline ala:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2021-01-20

Infovoldik

1
QR code to www.oeh.fi/bumt.
See the end of this leaflet, scan this code or visit www.oeh.fi/bumt
to see instructions on how to use
Easyhaler
PACKAGE LEAFLET: INFORMATION FOR THE USER
GIONA EASYHALER 100 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Giona Easyhaler is and what it is used for
2.
What you need to know before you use Giona Easyhaler
3.
How to use Giona Easyhaler
4.
Possible side effects
5.
How to store Giona Easyhaler
6.
Contents of the pack and other information
1.
WHAT GIONA EASYHALER IS AND WHAT IT IS USED FOR
The active ingredient in Giona Easyhaler 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.
Giona Easyhaler is a medicine called “
PREVENTER
”. It is used to prevent symptoms of asthma. It
belongs to a group of medicines called corticosteroids.
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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 noticable after a few days treatment
but will only reach its
maximum after a few weeks. You should use Giona Easyhaler regularly to
prevent the asthmatic
inflammation. Go on taking this medicine regularly according to
instructions, even if you don’t
have any symptoms.
2.
WHAT YOU NEED T

Toote omadused

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Giona Easyhaler 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: Giona Easyhaler 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 Giona Easyhaler 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.
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TWICE DAILY DOSING
Adults with mild, moderate or severe asthma (including the elderly