Symbicort Turbohaler 400 micrograms/12 micrograms/inhalation inhalation powder

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Formoterol fumarate dihydrate; Budesonide

Tilgængelig fra:

IMED Healthcare Ltd.

ATC-kode:

R03AK; R03AK07

INN (International Name):

Formoterol fumarate dihydrate; Budesonide

Dosering:

400 µg /12 µg/inhalation

Lægemiddelform:

Inhalation powder

Indgivelsesvej:

For inhalation use

Enheder i pakken:

1 inhaler containing 60 dose

Recept type:

Product subject to prescription which may be renewed (B)

Fremstillet af:

AstraZeneca AB

Terapeutisk gruppe:

Adrenergics and other drugs for obstructive airway diseases.

Terapeutisk område:

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

Terapeutiske indikationer:

It is indicated: in adults and adolescents aged 12 to 17 years for the regular treatment of asthma where use of a combination is appropriate; in adults, aged 18 years and older, for the symptomatic treatment of patients with severe COPD and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators

Autorisation status:

Authorised

Autorisation dato:

2015-05-15

Indlægsseddel

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 beta2 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 asthma symptoms,

Produktets egenskaber

Health Products Regulatory Authority
30 March 2023
CRN00DHHS
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.
Excipient with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from the Czech Republic_
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 is the date shown on the
inhaler and outer carton of the product on the market 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
30 March 2023
CRN00DHHS
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Symbicort Turbohaler is an inspiratory flow-driven, multi-dose powder
inhaler. The inhaler is white with a red turning grip. In
each secondary package there are 1 inhaler containing 60 doses.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
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
PPA1463/051/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15
th
May 2015
10 DATE OF REVISION OF THE TEXT
March 2023