Srivasso 18 microgram, inhalation powder, hard capsule

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Tiotropium

Verfügbar ab:

Boehringer Ingelheim International GmbH

ATC-Code:

R03BB; R03BB04

INN (Internationale Bezeichnung):

Tiotropium

Dosierung:

18 microgram(s)

Darreichungsform:

Inhalation powder, hard capsule

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Anticholinergics; tiotropium bromide

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2015-08-13

Gebrauchsinformation

S10/IE/MT/PI/2
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SRIVASSO 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 Srivasso 18 microgram is and what it is used for
2.
What you need to know before you useSrivasso 18 microgram
3.
How to use Srivasso 18 microgram
4.
Possible side effects
5.
How to store Srivasso 18 microgram
6.
Contents of the pack and other information
1.
WHAT SRIVASSO 18 MICROGRAM IS AND WHAT IT IS USED FOR
Srivasso 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 use Srivasso 18 microgram every day and not
only when you have
breathing problems or other symptoms of COPD.
Srivasso 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 Srivasso 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 Srivasso
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 once a day.

Fachinformation

HealthProductsRegulatoryAuthority
21June2019
CRN0094L4
Page1of13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Srivasso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approximately5.5milligrams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
Tiotropium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.
Tiotropiumbromidecapsulesareonlyforinhalationandnotfororalintake.
Tiotropiumbromidecapsulesmustnotbeswallowed.
Tiotropiumbromide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