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

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Formoterol fumatrate dihydrate; Budesonide

Disponibbli minn:

PCO Manufacturing Ltd.

Kodiċi ATC:

R03AK; R03AK07

INN (Isem Internazzjonali):

Formoterol fumatrate dihydrate; Budesonide

Dożaġġ:

400/12 microgram(s)/dose

Għamla farmaċewtika:

Inhalation powder

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

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

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2009-08-07

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
®
200 MICROGRAMS/6 MICROGRAMS/INHALATION,
INHALATION POWDER
budesonide/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 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 different
ways.
A)
SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: SYMBICORT TURBOHALER
AND A SEPARATE
‘RELIEVER INHALER’.

They use Symbicort Turbohaler every day. This helps to prevent asthma

Karatteristiċi tal-prodott

Health Products Regulatory Authority
22 September 2022
CRN00D5P1
Page 1 of 2
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.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_ _
_Product imported from France, Romania, Slovakia, Netherlands and
Belgium_
White powder
4 CLINICAL PARTICULARS
As per PA1019/020/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/020/003
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 carton 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.
Health Products Regulatory Authority
22 September 2022
CRN00D5P1
Page 2 of 2
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. In
each secondary package there is 1 inhaler containing 60 doses.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/225/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7th August 2009
Last updated: April 2011
Last updated: November 2014
Last updated: M