Symbicort 100/6 Turbohaler

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Budesonide; Formoterol fumarate dihydrate

Dostupno od:

AstraZeneca UK Ltd

ATC koda:

R03AK07

INN (International ime):

Budesonide; Formoterol fumarate dihydrate

Doziranje:

100microgram/1dose ; 6microgram/1dose

Farmaceutski oblik:

Inhalation powder

Administracija rute:

Inhalation

Razred:

No Controlled Drug Status

Tip recepta:

Caution - AMP level prescribing advised

Proizvod sažetak:

BNF: 03020000; GTIN: 5000455017238

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
® 100/6, 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, 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 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
bre

Svojstava lijeka

OBJECT 1
SYMBICORT TURBOHALER 100/6, INHALATION POWDER.
Summary of Product Characteristics Updated 07-Nov-2017 | AstraZeneca
UK Limited
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 with known effect
Lactose monohydrate 810 micrograms per delivered dose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder.
White powder.
4. Clinical particulars
4.1 Therapeutic indications
Symbicort Turbohaler is indicated in adults, adolescents, and children
aged 6 years and older.
Symbicort Turbohaler is indicated in the regular treatment of asthma
where use of a combination (inhaled
corticosteroid and long-acting β
2
adrenoceptor agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled short-acting β
2
adrenoceptor agonists.
or
- patients already adequately controlled on both inhaled
corticosteroids and long-acting β
2
adrenoceptor
agonists.
NOTE: Symbicort Turbohaler (100 micrograms/6 micrograms/inhalation) is
not appropriate in patients
with severe asthma.
4.2 Posology and method of administration
Route of administration: For inhalation use
Posology
Symbicort Turbohaler is not intended for the initial management of
asthma. The dosage of the
components of Symbicort is individual and should be adjusted to the
severity of the disease. This should
be considered not only when treatment with combination products is
initiated but also when the
maintenance dose is adjusted. If an individual patient should require
a combination of doses other than
those available in the combination inhaler, appropriate doses of β
2
adrenocep