Tiotropium DEMO, 18 microgram, inhalation powder, hard capsule

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

TIOTROPIUM BROMIDE

Tilgjengelig fra:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

ATC-kode:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE 21.7 µg

Legemiddelform:

INHALATION POWDER, HARD CAPSULE

Sammensetning:

TIOTROPIUM BROMIDE 21.7 µg

Resept typen:

POM

Terapeutisk område:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Produkt oppsummering:

Licence number in the source country: NOT APPLICAPABLE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2021-05-27

Informasjon til brukeren

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIOTROPIUM DEMO 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 Tiotropium DEMO is and what it is used for
2.
What you need to know before you use Tiotropium DEMO
3.
How to use Tiotropium DEMO
4.
Possible side effects
5.
How to store Tiotropium DEMO
6.
Contents of the pack and other information
1.
WHAT TIOTROPIUM DEMO IS AND WHAT IT IS USED FOR
Tiotropium DEMO 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 Tiotropium DEMO every day and not only
when you have
breathing problems or other symptoms of COPD.
Tiotropium DEMO 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 Tiotropium
DEMO can also help you when
you have on-going shortness of breath related to your disease and will
help you to minimize the
effects of the disease on your everyday life. It also helps you to be
active longer. Daily use of
Tiotropium DEMO 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. For correct dosing of Tiotropium DEMO
p

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tiotropium DEMO, 18 microgram, inhalation powder, hard capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 21.7 microgram tiotropium bromide equivalent to
18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece) is 10
microgram tiotropium.
Excipient(s) 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.
Transparent colourless hard capsules containing white inhalation
powder with ‘T10’ 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 recommended dosage of tiotropium bromide is inhalation of the
contents of one capsule once
daily with the Dry Powder Inhaler at the same time of day.
The recommended dose should not be exceeded.
Tiotropium bromide capsules are only for inhalation.
Tiotropium bromide capsules must not be swallowed.
Tiotropium bromide should only be inhaled with the Dry Powder Inhaler.
Special populations
_Elderly Patients _
Elderly patients can use tiotropium bromide at the recommended dose.
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_Renal Impairment _
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.
_Hepatic Impairment _
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.
_Cystic fibrosis _
The safety and efficacy of Tiotropium DEMO 18 microgram in children
and adolescents has not
been established. No