Spiriva 18 microgram inhalation powder, hard capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiotropium

Available from:

IMED Healthcare Ltd.

ATC code:

R03BB; R03BB04

INN (International Name):

Tiotropium

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:

2011-02-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA®
18 MICROGRAM, INHALATION POWDER, HARD CAPSULE
tiotropium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
IN THIS LEAFLET:
1. What SPIRIVA 18 microgram is and what it is used for
2. What you need to know before you take SPIRIVA 18 microgram
3. How to take 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 hours, so you only need to
take it once a day. For correct dosing of
SPIRIVA 18 mic

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: Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
_Product imported from Italy, the UK, Romania, Bulgaria 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 contains milk protein)
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.
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6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium / PVC / Al