Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation inhalation powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Formoterol fumatrate dihydrate; Budesonide

Available from:

IMED Healthcare Ltd.

ATC code:

R03AK; R03AK07

INN (International Name):

Formoterol fumatrate dihydrate; Budesonide

Dosage:

200 µg/6 µg/inhalation

Pharmaceutical form:

Inhalation powder

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Authorised

Authorization date:

2011-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT® TURBOHALER® 200 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 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
Symbicort Turbohaler 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 happenin

Summary of Product characteristics

Health Products Regulatory Authority
30 March 2023
CRN00DHHS
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation inhalation
powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 160 micrograms/inhalation and formoterol
fumarate dihydrate 4.5 micrograms/inhalation.
Each metered dose contains: budesonide 200 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_
White powder.
4 CLINICAL PARTICULARS
As per PA1019/020/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1019/020/002
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, multidose powder
inhaler. The inhaler is white with a red turning grip. The
inhaler is made of different plastic materials.
Each inhaler contains 120 doses. There is one inhaler per carton.
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
PPA1463/051/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23
rd
September 2011
10 DATE OF REVISION OF THE TEXT
March 2023