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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Budesonide; Formoterol fumatrate dihydrate

Available from:

PCO Manufacturing Ltd.

ATC code:

R03AK; R03AK07

INN (International Name):

Budesonide; Formoterol fumatrate dihydrate

Dosage:

200 µg/6 microgram(s)/dose

Pharmaceutical form:

Inhalation powder

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Authorised

Authorization date:

2009-08-07

Patient Information leaflet

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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

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2022
CRN00D5PF
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(s) with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from France, Slovakia , Romania,the Netherlands and
Belgium_
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 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
CRN00D5PF
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 120 doses
Product sourced from Romania consists of 2 inhalers with 60 doses per
pack.
Not all pack sizes may be marketed
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
PPA0465/225/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION