Symbicort Turbohaler, 100 micrograms /6 micrograms/inhalation, inhalation powder

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Budesonide; Formoterol fumatrate dihydrate

Saadav alates:

PCO Manufacturing Ltd.

ATC kood:

R03AK; R03AK07

INN (Rahvusvaheline Nimetus):

Budesonide; Formoterol fumatrate dihydrate

Annus:

100/6 microgram(s)/dose

Ravimvorm:

Inhalation powder

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

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

Volitamisolek:

Authorised

Loa andmise kuupäev:

2012-08-31

Infovoldik

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
®
400 MICROGRAMS/12 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
For asthma, your doctor will prescribe two asthma inhalers: Symbicort
Turbohaler and a
separate ‘reliever inhaler’.

Use Symbicort Turbohaler every day. This helps to prevent asthma
symptoms from
happening.

Use your ‘reliever inhaler’ when you get asthm

Toote omadused

Health Products Regulatory Authority
22 September 2022
CRN00D5P0
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort Turbohaler, 100 micrograms /6 micrograms/inhalation,
inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 80 micrograms/inhalation and formoterol
fumarate dihydrate 4.5 micrograms/inhalation.
Each metered dose contains: budesonide 100 micrograms/inhalation and
formoterol fumarate dihydrate 6
micrograms/inhalation.
Excipient(s) with known effect: Lactosemonohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from Italy, Romania and Greece_
White powder
4 CLINICAL PARTICULARS
As per PA1019/020/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/020/001
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
CRN00D5P0
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 or 120 doses.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
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
PPA0465/225/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
August 2012
10 DATE OF REVISION OF THE T