Symbicort Turbohaler, 200 micrograms/6 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:

200/6 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
®
200 MICROGRAMS/6 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
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 happening.
•
They use their ‘reliever inhaler’ when they get asthma symptoms,
to
make it easier to breathe again.
B) SOME PEOPLE ARE PRESCRIBED SYMBICORT TURBOHALER AS THEIR ONLY
ASTHMA INHALER.
•
They
use Symbicort
Turbohaler every day. This
helps to prevent
asthma symptoms from happening.
•
They also use Symbicort Turbohaler when they need extra doses for
relief of asthma symptoms, to make it easier to breathe again and if
agreed
with
the
doctor
also
to
prevent
asthma
symptoms
from
happening (for example, when exercising or on exposure to

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, 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.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from Slovakia_
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
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.
The inhaler has a white body with a red turning grip.
Each carton contains 1 inhaler containing 120 doses.
Health Products Regulatory Authority
25 August 2020
CRN009SCX
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local 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
PPA1633/074/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
August 2020
10 DATE OF REVISION OF THE TEXT