Spiriva Respimat 2.5 microgram Solution for Inhalation

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiotropium

Available from:

Imbat Limited

ATC code:

R03BB; R03BB04

INN (International Name):

Tiotropium

Dosage:

2.5 microgram(s)

Pharmaceutical form:

Inhalation solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anticholinergics; tiotropium bromide

Authorization status:

Authorised

Authorization date:

2011-09-30

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
® RESPIMAT
® 2.5 MICROGRAM, INHALATION SOLUTION
(tiotropium)
Your medicine is available using the name Spiriva Respimat 2.5
microgram, inhalation solution
but will be referred to as Spiriva Respimat 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 RESPIMAT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPIRIVA RESPIMAT
3.
HOW TO USE SPIRIVA RESPIMAT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SPIRIVA RESPIMAT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SPIRIVA RESPIMAT IS AND WHAT IT IS USED FOR
Spiriva Respimat helps people who have chronic obstructive pulmonary
disease (COPD) or
asthma to breathe more easily. COPD is a long-term lung disease that
causes shortness of
breath and coughing. The term COPD is associated with the conditions
chronic bronchitis and
emphysema. Asthma is a long-term disease characterised by airway
inflammation and
narrowing of the airways. As COPD and asthma are long-term diseases
you should use Spiriva
Respimat every day and not only when you have breathing problems or
other symptoms. When
used to treat asthma you should use Spiriva Respimat in addition to
so-called inhaled
corticosteroids and long-acting β
2
agonists.
Spiriva Respimat 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
Respimat can also help you when
you have on-going shortness of bre

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2019
CRN0095QT
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiriva Respimat 2.5 microgram Solution for Inhalation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs
comprise one medicinal dose) and is equivalent to 3.124
microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipient with known effect: This medicine contains 0.0011 mg
benzalkonium chloride in each actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation solution
_Product imported from France, Italy & UK_
Clear, colourless, solution for inhalation
4 CLINICAL PARTICULARS
As per PA 0775/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA 0775/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Disodium edetate
Purified water
Hydrochloric acid 3.6 % (for pH adjustment)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the containers and outer package of the product as
marketed in the country of origin.
In-use shelf life: 3 months.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Outer carton containing respimat inhaler and cartridge.
Health Products Regulatory Authority
03 November 2019
CRN0095QT
Page 2 of 2
1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal
doses).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/018/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 30
th
September 2011
10 DATE OF REVISION OF THE TEXT
November 2019