SYMBICORT TURBOHALER 200/6 Mcg/Dose Powder for Inhalation

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Available from:

LTT Pharma Limited

ATC code:

R03AK07

INN (International Name):

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Dosage:

200/6 Mcg/Dose

Pharmaceutical form:

Powder for Inhalation

Administration route:

inspiratory flow-driven

Units in package:

Each inhaler contains 120 doses

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

AstraZeneca AB, AstraZeneca GmbH, AstraZeneca UK Limited

Therapeutic group:

Adrenergics and other drugs for obstructive airway diseases

Therapeutic area:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Therapeutic indications:

It is indicated in adults and adolescents aged 12 to 17 years for the regular treatment of asthma and for the symptomatic treatment of patients with severe COPD

Authorization status:

Authorised

Authorization date:

2015-08-07

Patient Information leaflet

The effects include:
•
changes in bone mineral density (thinning of the
bones)
•
cataract (clouding of the lens in the eye)
•
glaucoma (increased pressure in the eye)
•
a slowing of the rate of growth of children and
adolescents
•
an effect on the adrenal gland (a small gland
next to the kidney).
These effects are much less likely to happen with
inhaled corticosteroids than with corticosteroid
tablets.
REPORTING OF SIDE EFFECTS
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: [phone]; Fax: [phone].
Website: www.hpra.ie; E-mail:[e-mail].
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE SYMBICORT TURBOHALER
•
Keep this medicine out of the sight and reach of
children.
•
Do not use this medicine after the expiry date
which is stated on the label and carton.
The expiry date refers to the last day of that
month.
•
Do not store above 30°C.
•
Keep the container/cap tightly closed, in order
to protect from moisture.
•
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT SYMBICORT 200/6 TURBOHALER CONTAINS
The active substances are budesonide and
formoterol fumarate dihydrate. Each inhaled dose
contains 160 micrograms of budesonide and 4.5
mg of formoterol fumarate dihydrate, this
corresponds to a metered dose of 200 micrograms
of budesonide and 6 micrograms of formoterol
fumarate dihydrate.
The other ingredient is lactose monohydrate
(which contains milk proteins).
WHAT SYMBICORT 200/6 TURBOHALER LOOKS LIKE
AND CONTENTS OF THE PACK
Symbicort 200/6 Turbohaler is an inhaler
containing your medicine. The inhalation powder is
white in colour. Each Turboh

Summary of Product characteristics

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: Contains Lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from Slovakia_
White powder
4 CLINICAL PARTICULARS
As per PA0970/028/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/028/002
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 for this product shall be the date shown on the inhaler and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
°
C. Keep the container tightly closed, in order to protect from moisture.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/01/2017_
_CRN 2185964_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Symbicort Turbohaler is an inspiratory flow-driven, multidose powder inhaler.
The inhaler is white with a red turning grip.
Each inhaler contains 120 doses.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION