SYMBICORT TURBOHALER 400/12 Mcg/Dose Powder for Inhalation

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Available from:

LTT Pharma Limited

ATC code:

R03AK07

INN (International Name):

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Dosage:

400/12 Mcg/Dose

Pharmaceutical form:

Powder for Inhalation

Administration route:

inspiratory flow-driven

Units in package:

Each inhaler containing 60 doses

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

AstraZeneca AB, AstraZeneca GmbH, AstraZeneca UK Limited

Therapeutic group:

Adrenergics and other drugs for obstructive airway diseases

Therapeutic area:

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

Therapeutic indications:

It is indicated in adults and adolescents aged 12 to17 years for the regular treatment of asthma and for the symptomatic treatment of patients with severe COPD

Authorization status:

Authorised

Authorization date:

2015-08-07

Patient Information leaflet

THE MANUFACTURER IS:
AstraZeneca AB, Sӧdertälje, Sweden
AstraZeneca GmbH, Wedel, Germany
AstraZeneca UK Limited, Cheshire, UK
Symbicort and Turbohaler are registered
trademarks of the AstraZeneca AB
Leaflet revision date: 10/01/2017
PPA1562/165/002
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited,
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THIS MEDICINAL PRODUCT IS AUTHORISED IN THE
MEMBER STATES OF THE EEA UNDER THE FOLLOWING
NAMES:
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 br

Summary of Product characteristics

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: Contains Lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from Slovakia_
White powder
4 CLINICAL PARTICULARS
As per PA0970/028/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/028/003
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 for this product shall be the date shown on the inhaler and outer package 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
________________________________________________________________________________________________________________________
_Date Printed 06/01/2017_
_CRN 2185964_
_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 containing 60 doses.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION