Spiriva Respimat 2.5 microgram, solution for inhalation

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Tiotropium

متاح من:

IMED Healthcare Ltd.

ATC رمز:

R03BB; R03BB04

INN (الاسم الدولي):

Tiotropium

جرعة:

2.5 microgram(s)

الشكل الصيدلاني:

Solution for Inhalation

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Anticholinergics; tiotropium bromide

الوضع إذن:

Authorised

تاريخ الترخيص:

2012-11-16

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA® RESPIMAT® 2.5 MICROGRAM, SOLUTION FOR INHALATION
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. 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 take SPIRIVA RESPIMAT
3. How to take SPIRIVA RESPIMAT
4. Possible side effects
5. How to store SPIRIVA RESPIMAT
6. Contents of the pack and further 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 take 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 β2 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
ongoing shortness of breath related to your disease, and will help to
minimise the effects of the disease on
your everyday life. Daily use of SPIRIVA RESPIMAT will also help to
prevent any sudd

خصائص المنتج

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.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for inhalation
_Product imported from Italy_
Clear, colourless, solution for inhalation
4 CLINICAL PARTICULARS
As per PA0775/002/002.
5 PHARMACOLOGICAL PROPERTIES
As per PA0775/002/002.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Disodium edetate
Water, purified
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 container and outer package of the product on
the market in the country of origin.
In-use shelf life: 3 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not freeze.
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6.5 NATURE AND CONTENTS OF CONTAINER
Pack size and device supplied:
Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
6.6 SPECIAL PRECAUTIONS FOR DIS