Spiriva 18 microgram inhalation powder, hard capsule

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Tiotropium

Tillgänglig från:

PCO Manufacturing Ltd.

ATC-kod:

R03BB; R03BB04

INN (International namn):

Tiotropium

Dos:

18 microgram(s)

Läkemedelsform:

Inhalation powder, hard capsule

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Anticholinergics; tiotropium bromide

Bemyndigande status:

Authorised

Tillstånd datum:

2007-08-24

Bipacksedel

_Pil 465-186-1-7597_
_ _
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_Pil 465-186-1-7597_
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PACKAGE LEAFLET : INFORMATION FOR THE USER
SPIRIVA
®
18 MICROGRAM, INHALATION POWDER, HARD CAPSULE
tiotropium
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 SPIRIVA 18 microgram is and what it is used for
2.
What you need to know before you use SPIRIVA 18 microgram
3.
How to use SPIRIVA 18 microgram
4.
Possible side effects
5.
How to store SPIRIVA 18 microgram
6.
Contents of the pack and other information
1.
WHAT SPIRIVA 18 MICROGRAM IS AND WHAT IT IS USED FOR
SPIRIVA 18 microgram helps people who have chronic obstructive
pulmonary disease (COPD)
to breathe more easily. COPD is a chronic lung disease that causes
shortness of breath and
coughing. The term COPD is associated with the conditions chronic
bronchitis and
emphysema. As COPD is a chronic disease you should take SPIRIVA 18
microgram every day
and not only when you have breathing problems or other symptoms of
COPD.
SPIRIVA 18 microgram is a long acting bronchodilator that helps to
open your airways and
makes it easier to get air in and out of the lungs. Regular use of
SPIRIVA 18 microgram can
also help you when you have on-going shortness of breath related to
your disease and will help
you to minimise the effects of the disease on your everyday life. It
also helps you to be active
longer. Daily use of SPIRIVA 18 microgram will also help to prevent
sudden, short-term
worsening of your COPD symptoms which may last for several days. The
effect of this
medicine lasts for 24 hour

Produktens egenskaper

Health Products Regulatory Authority
15 June 2020
CRN009S7D
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiriva 18 microgram inhalation powder, hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.5 microgram tiotropium bromide monohydrate
equivalent to 18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the
HandiHaler device) is 10 microgram tiotropium.
Excipient with known effect: Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
_Product imported from Germany, Spain, Italy, theUnited
Kingdom,France, Greece, Romania, Lithuania, Norway and Poland:_
Light green hard capsules with the product code 'TI 01' and company
logo printed on the capsule.
4 CLINICAL PARTICULARS
As per PA0775/002/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA0775/002/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate (which may contain small amounts of milk
proteins).
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
After first opening of the blister: 9 days
Discard the Handihaler device 12 months after first use.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C
Do not freeze
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips containing 10 capsules
The HandiHaler is a single dose inhalation device.
Package sizes and devices supplied:
• Cardboard box containing 30 capsules (3 blister strips)
Health Products Regulatory Authority
15 June 2020
CRN009S7D
Page 2 of 2
• Cardboard box containing 60 capsules (6 blister strips)
• Cardboard box containing HandiHaler device and 30 capsules (3
blister strips)
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL