Symbicort 200/6 Turbohaler

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Budesonide; Formoterol fumarate dihydrate

Tillgänglig från:

AstraZeneca UK Ltd

ATC-kod:

R03AK07

INN (International namn):

Budesonide; Formoterol fumarate dihydrate

Dos:

200microgram/1dose ; 6microgram/1dose

Läkemedelsform:

Inhalation powder

Administreringssätt:

Inhalation

Klass:

No Controlled Drug Status

Receptbelagda typ:

Caution - AMP level prescribing advised

Produktsammanfattning:

BNF: 03020000; GTIN: 5000455017245

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® TURBOHALER
® 200/6, 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 and adolescents aged
12 – 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 ‘reli

Produktens egenskaper

OBJECT 1
SYMBICORT TURBOHALER 200/6 INHALATION POWDER
Summary of Product Characteristics Updated 08-May-2018 | AstraZeneca
UK Limited
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 730 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
ASTHMA
Symbicort Turbohaler is indicated in adults and adolescents (12 years
and older) for 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.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Turbohaler is indicated in adults, aged 18 years and older,
for the symptomatic treatment of
patients with COPD with forced expiratory volume in 1 second (FEV
1
) <70% predicted normal (post
bronchodilator) and an exacerbation history despite regular
bronchodilator therapy (see also section 4.4).
4.2 Posology and method of administration
Route of administration: For inhalation use.
Posology
ASTHMA
Symbicort 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 w