Symbicort, 200 micrograms/6 micrograms per inhalation, pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Budesonide micronised; Formoterol fumarate dihydrate (micronised)

Available from:

AstraZeneca UK Limited

ATC code:

R03AK; R03AK07

INN (International Name):

Budesonide micronised; Formoterol fumarate dihydrate (micronised)

Dosage:

200/6 Mcg/Acutuation

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Authorised

Authorization date:

2016-07-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT
® 200 MICROGRAMS /6 MICROGRAMS PER INHALATION, 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort, 200 micrograms/6 micrograms per inhalation, 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 canister at high velocity. When the patient
inhales through the mouthpiece at the same time as actuating the
inhaler, the substance will follow the