Symbicort Turbohaler 100 micrograms/6 micrograms/inhalation inhalation powder

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Budesonide; Formoterol fumatrate dihydrate

Dostupno od:

IMED Healthcare Ltd.

ATC koda:

R03AK; R03AK07

INN (International ime):

Budesonide; Formoterol fumatrate dihydrate

Doziranje:

100 µg/6 µg/inhalation

Farmaceutski oblik:

Inhalation powder

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

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

Status autorizacije:

Authorised

Datum autorizacije:

2010-10-29

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
® 100 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, adolescents and children aged 6
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.
This medicine is not suitable for people with severe asthma. It 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
symptoms from happening.
•
They use their ‘reliever inhaler’ when they get asthma sy

Svojstava lijeka

Health Products Regulatory Authority
10 November 2022
CRN00D77Y
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 with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
_Product imported from Czech Republic and France_
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 is the date shown on the
turbohaler 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.
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. The
inhaler is made of different plastic materials.
Health Products Regulatory Authority
10 November 2022
CRN00D77Y
Page 2 of 2
Each inhaler contains 120 doses. There is one inhaler per carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/051/002
9 DATE OF FIRST AUTHORISATI