Symbicort 200micrograms/dose / 6micrograms/dose pressurised inhaler

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Formoterol fumarate dihydrate; Budesonide

Saadav alates:

AstraZeneca UK Ltd

ATC kood:

R03AK07

INN (Rahvusvaheline Nimetus):

Formoterol fumarate dihydrate; Budesonide

Annus:

6microgram/1dose ; 200microgram/1dose

Ravimvorm:

Pressurised inhalation

Manustamisviis:

Inhalation

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 03020000; GTIN: 5000456011679

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® 200 MICROGRAMS/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION,
SUSPENSION
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 is and what it is used for
2.
What you need to know before you use Symbicort
3.
How to use Symbicort
4.
Possible side effects
5.
How to store Symbicort
6.
Contents of the pack and other information
1.
WHAT SYMBICORT IS AND WHAT IT IS USED FOR
Symbicort is an inhaler that is used to treat the symptoms of Chronic
Obstructive Pulmonary Disease
(COPD) in adults aged 18 and older. COPD is a long-term disease of the
airways in the lungs, which is often
caused by cigarette smoking. Symbicort 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.
Do not use this medicine as a “reliever” inhaler.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SYMBICORT
DO NOT USE SYMBICORT:

if you are allergic to budesonide, formoterol or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Sy

Toote omadused

OBJECT 1
SYMBICORT, 200 MICROGRAMS/6 MICROGRAMS PER
ACTUATION, PRESSURISED INHALATION, SUSPENSION
Summary of Product Characteristics Updated 22-Jun-2018 | AstraZeneca
UK Limited
1. Name of the medicinal product
Symbicort, 200 micrograms/6 micrograms per actuation, pressurised
inhalation, suspension
2. Qualitative and quantitative composition
Each delivered dose (ex-actuator) contains: budesonide 160
micrograms/actuation and formoterol
fumarate dihydrate 4.5 micrograms/actuation.
This is equivalent to a metered dose containing budesonide 200
micrograms/actuation and formoterol
fumarate dihydrate 6 micrograms/actuation.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised inhalation, suspension.
White suspension in an aluminium canister fitted into a red actuator
with a grey dust cap.
4. Clinical particulars
4.1 Therapeutic indications
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort is indicated in adults, aged 18 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: Inhalation use.
COPD
_Recommended dose:_
_Adults:_ 2 actuations twice daily.
GENERAL INFORMATION
_Special patient groups:_
There are no special dosing requirements for elderly patients. There
are no data available for use of
Symbicort in patients with hepatic or renal impairment. As budesonide
and formoterol are primarily
eliminated via hepatic metabolism, an increased exposure can be
expected in patients with severe liver
cirrhosis.
_Paediatric Population_
There is no relevant use of Symbicort 200 micrograms /6 micrograms in
children 11 years of age and
under or in adolescents 12 to 17 years of age in the symptomatic
treatment of COPD.
INSTRUCTIONS FOR THE CORRECT USE OF SYMBICORT
On actuation of Symbicort, a volume of the suspension is expelled from
the