Srivasso 18 microgram, inhalatiepoeder in harde capsules

Nazione: Paesi Bassi

Lingua: olandese

Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Principio attivo:

TIOTROPIUMBROMIDE 1-WATER 22,5 µg/stuk SAMENSTELLING overeenkomend met ; TIOTROPIUM 18 µg/stuk

Commercializzato da:

Boehringer Ingelheim International GmbH Bingerstrasse 173 D-55216 INGELHEIM AM RHEIN (DUITSLAND)

Codice ATC:

R03BB04

INN (Nome Internazionale):

TIOTROPIUMBROMIDE 1-WATER 22,5 µg/stuk SAMENSTELLING overeenkomend met ; TIOTROPIUM 18 µg/stuk

Forma farmaceutica:

Inhalatiepoeder in harde capsule

Composizione:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; POLYETHYLEENGLYCOL (E 1521) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Via di somministrazione:

Inhalatie

Area terapeutica:

Tiotropium Bromide

Dettagli prodotto:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; LECITHINE, SOYA (E 322); POLYETHYLEENGLYCOL (E 1521); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TITAANDIOXIDE (E 171); ZWARTE INKT;

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

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PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SRIVASSO 18 MICROGRAM INHALATIE POEDER IN HARDE CAPSULES
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

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Srivasso 18 microgram, inhalatiepoeder in harde capsules
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
Srivasso 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.
Srivasso capsules are only for inhalation and not for oral intake.
Srivasso capsules must not be swallowed.
Srivasso 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 moderate
to severe impairment (creatinine clearance
≤
50 ml/min) see section 4.4 and section 5.2.
Hepatically impaired patients can use tiotropium bromide at the
recommended dose (see section 5.2).
_Paediatric population _
_ _
_COPD _
There is no relevant use in the paediatric population (below 18 years)
in the indication stated under section
4.1.
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_Cystic fibrosis _
The safety and efficacy of Srivasso 18 microgram in children and
adole