SYMBICORT TURBOHALER 100mcg/6 Mcg/Dose Powder for Inhalation

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUDESONIDE, FORMOTEROL FUMATRATE DIHYDRATE

Available from:

Imbat Limited

ATC code:

R03AK07

INN (International Name):

BUDESONIDE, FORMOTEROL FUMATRATE DIHYDRATE

Dosage:

100mcg/6 Mcg/Dose

Pharmaceutical form:

Powder for Inhalation

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Authorization status:

Authorised

Authorization date:

2011-06-03

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
® 100 MICROGRAMS/ 6 MICROGRAMS/ INHALATION,
INHALATION POWDER
(budesonide / formoterol fumarate dihydrate)
Your medicine is available using the name Symbicort Turbohaler 100
micrograms / 6
micrograms / inhalation, inhalation powder but will be referred to as
Symbicort Turbohaler
throughout this leaflet.
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

Summary of Product characteristics

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: Lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from Romania and Poland_
White powder
4 CLINICAL PARTICULARS
As per PA0970/028/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/028/001
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 package of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original container.
Keep the container tightly closed, in order to protect from moisture.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 08/12/2015_
_CRN 2171333_
_page number: 1_
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.
Each inhaler contains 60 doses. Each carton contains 2 inhalers.
Pack size: 120 doses.
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�