Symbicort Turbohaler, 400 micrograms/12 micrograms/inhalation, inhalation powder

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Budesonide; Formoterol fumatrate dihydrate

Dostopno od:

Imbat Limited

Koda artikla:

R03AK; R03AK07

INN (mednarodno ime):

Budesonide; Formoterol fumatrate dihydrate

Odmerek:

400mcg/12mcg Mcg/Dose

Farmacevtska oblika:

Powder for Inhalation

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Status dovoljenje:

Authorised

Datum dovoljenje:

2011-06-03

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
® 400 MICROGRAMS / 12 MICROGRAMS / INHALATION,
INHALATION POWDER
(budesonide / formoterol fumarate dihydrate)
Your medicine is available using the name Symbicort Turbohaler 400
micrograms / 12
micrograms / inhalation, inhalation powder but will be referred to as
Symbicort Turbohaler
throughout this leaflet.
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 SYMBICORT TURBOHALER IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SYMBICORT TURBOHALER
3.
HOW TO USE SYMBICORT TURBOHALER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SYMBICORT TURBOHALER
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SYMBICORT TURBOHALER IS AND WHAT IT IS USED FOR
Symbicort Turbohaler is an inhaler that is used to treat asthma in
adults and adolescents aged
12 to 17 years. It is also used to treat the symptoms of Chronic
Obstructive Pulmonary Disease
(COPD) in adults aged 18 years and older. It contains two different
medicines: budesonide and
formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing
and preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting beta
2
adrenoceptor agonists’ or ‘bronchodilators’. It works by
relaxing the muscles in your
airways. This helps you to breathe more easily.
ASTHMA
For asthma, your doctor will prescribe two asthma inhaler

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort Turbohaler, 400 micrograms/12 micrograms/inhalation,
inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 320 micrograms/inhalation and
formoterol fumarate dihydrate 9 micrograms/inhalation.
Each metered dose contains: budesonide 400 micrograms/inhalation and
formoterol fumarate dihydrate 12
micrograms/inhalation.
Excipient: Lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from France, Poland and UK._
White powder
4 CLINICAL PARTICULARS
As per PA0970/028/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/028/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate (which contains milk proteins).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30° C.
Keep the container tightly closed, in order to protect from moisture.
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6.5 NATURE AND CONTENTS OF CONTAINER
Symbicort Turbohaler is an inspiratory flow driven, multidose powder
inhaler.
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