Spiriva 18 microgram, inhalation powder, hard capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiotropium bromide

Available from:

Imbat Limited

ATC code:

R03BB; R03BB04

INN (International Name):

Tiotropium bromide

Dosage:

18 microgram(s)

Pharmaceutical form:

Inhalation powder, hard capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anticholinergics; tiotropium bromide

Authorization status:

Authorised

Authorization date:

2006-11-27

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
® 18 MICROGRAM, INHALATION POWDER, HARD CAPSULE
(tiotropium)
Your medicine is available using the above name but will be referred
to as Spiriva throughout
this leaflet.
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 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPIRIVA
3.
HOW TO USE SPIRIVA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SPIRIVA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SPIRIVA IS AND WHAT IT IS USED FOR
Spiriva 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 every day and not only when
you have breathing
problems or other symptoms of COPD.
Spiriva 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 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 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 hours, so you
only need to use it once a
day. For correct dosing of

Summary of Product characteristics

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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule
_Product imported from Bulgaria, France, Italy, Romania, Spain and the
UK:_
Light green hard capsules containing the inhalation powder 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
blister strips and outer carton of the product as
marketed in the country of origin.
After first opening of the blister use within the next 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.
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