Symbicort Turbohaler, 400 micrograms/12 micrograms/inhalation, inhalation powder

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Budesonide dihydrate; Formoterol fumarate dihydrate

Prieinama:

Primecrown 2010 Limited

ATC kodas:

R03AK; R03AK07

INN (Tarptautinis Pavadinimas):

Budesonide dihydrate; Formoterol fumarate dihydrate

Dozė:

400/12 µg/µg

Vaisto forma:

Inhalation powder

Gydymo sritis:

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

Leidimo data:

2020-08-25

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
®
TURBOHALER
®
400 MICROGRAMS/12 MICROGRAMS/INHALATION, INHALATION POWDER
Budesonide/Formoterol fumarate dihydrate
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 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, to make
it
easier to breathe again.
Do not use Symbicort 400/12 Turbohaler as a ‘reliever inhaler’.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Turbohaler can also be used to treat the symptoms of COPD in
adults. COPD is a long-term disease of the airways in the lungs, which
is
often caused by cigarette smoking.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYMBICORT
TURBOHALER
DO NOT USE SYMBICORT TURBOHALER:
•
if you are allergic to budesonide, formoterol, or the other ingredient
of
this medicine (listed in section 6), which is

Prekės savybės

Health Products Regulatory Authority
25 August 2020
CRN009SCX
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 Slovakia_
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
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Symbicort Turbohaler is an inspiratory flow-driven, multidose powder
inhaler.
Health Products Regulatory Authority
25 August 2020
CRN009SCX
Page 2 of 2
The inhaler has a white body with a red turning grip.
Each carton contains 1 inhaler containing 60 doses.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex
UB5 5QS
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/074/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
August 2020
10 DATE OF REVISION OF THE TEXT