SPIRIVA 18 microgram, inhalation powder, hard capsule

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Tiotropium

Saadav alates:

Boehringer Ingelheim International GmbH

ATC kood:

R03BB; R03BB04

INN (Rahvusvaheline Nimetus):

Tiotropium

Annus:

18 microgram(s)

Ravimvorm:

Inhalation powder, hard capsule

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Anticholinergics; tiotropium bromide

Volitamisolek:

Marketed

Loa andmise kuupäev:

2002-06-28

Infovoldik

S8/IE-MT/PI/WS641
06/01/2022
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 hours, so you only need to
use it onc

Toote omadused

HealthProductsRegulatoryAuthority
27April2023
CRN00D3D8
Page1of14
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:
Eachcapsulecontains5.5milligramoflactose(asmonohydrate).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Inhalationpowder,hardcapsule.
LightgreenhardcapsulescontainingtheinhalationpowderwiththeproductcodeTI01andcompanylogoprintedonthe
capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Spirivaisindicatedasamaintenancebronchodilatortreatmenttorelievesymptomsofpatientswithchronicobstructive
pulmonarydisease(COPD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Themedicinalproductisintendedforinhalationuseonly.
TherecommendeddosageoftiotropiumbromideisinhalationofthecontentsofonecapsuleoncedailywiththeHandiHaler
deviceatthesametimeofday.
Therecommendeddoseshouldnotbeexceeded.
Spirivacapsulesareonlyforinhalationandnotfororalintake.
Spirivacapsulesmustnotbeswallowed.
SpirivacapsulesshouldonlybeinhaledwiththeHandiHalerdevice.
Special populations
Geriatricpatientscanusetiotropiumbromideattherecommendeddose.
Renallyimpairedpatientscanusetiotropiumbromideattherecommendeddose.Forpatientswithmoderat