Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation, inhalation powder

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Formoterol fumatrate dihydrate; Budesonide

Saatavilla:

Imbat Limited

ATC-koodi:

R03AK; R03AK07

INN (Kansainvälinen yleisnimi):

Formoterol fumatrate dihydrate; Budesonide

Annos:

200 µg/6 microgram(s)

Lääkemuoto:

Inhalation powder

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

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

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-06-03

Pakkausseloste

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
® 200 MICROGRAMS / 6 MICROGRAMS / INHALATION,
INHALATION POWDER
budesonide / formoterol fumarate dihydrate
Your medicine is available using the name Symbicort Turbohaler 200
micrograms /
6 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
Symbicort Turbohaler can be prescribed for asthma in two diff

Valmisteyhteenveto

Health Products Regulatory Authority
31 July 2019
CRN00968V
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation,
inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 160 micrograms/inhalation and formoterol
fumarate dihydrate 4.5 micrograms/inhalation.
Each metered dose contains: budesonide 200 micrograms/inhalation and
formoterol fumarate dihydrate 6
micrograms/inhalation.
Excipient with known effect: Lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from France, Poland, Romania and UK:_
White powder
4 CLINICAL PARTICULARS
As per PA1019/020/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/020/002
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
_Product imported from France _
This medicinal product does not require any special storage
conditions.
_Product imported from Poland, Romania and United Kingdom_
Do not store above 30°C.
Store in the original container.
Health Products Regulatory Authority
31 July 2019
CRN00968V
Page 2 of 2
Keep the container tightly closed, in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Symbicort Turbohaler is an inspiratory flow driven, multidose powder
inhaler.
The inhaler is white with a red turning grip.
_Product imported from Romania and Poland:_
Each inhaler contains 60 doses. Each carton containers 2 inhalers.
_Product imported from France and UK:_
Each inahler contains 120 doses. Each carton contains 1 inhaler.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WA