Adcopium 10 microgram inhalatiepoeder, voorverdeeld

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TIOTROPIUMBROMIDE 1-WATER 16 µg/dosis SAMENSTELLING overeenkomend met ; TIOTROPIUM 13 µg/dosis

INN (Algemene Internationale Benaming):

TIOTROPIUMBROMIDE 1-WATER 16 µg/dosis SAMENSTELLING overeenkomend met ; TIOTROPIUM 13 µg/dosis

farmaceutische vorm:

Inhalatiepoeder, voorverdeeld

Samenstelling:

LACTOSE 1-WATER

Toedieningsweg:

Inhalatie

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ADCOPIUM 10 MICROGRAM INHALATIEPOEDER, VOORVERDEELD
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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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 every day and not only when you have breathing
problems or other symptoms
of COPD.
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 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 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 please see section 3. How to use

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Adcopium 10 microgram inhalatiepoeder, voorverdeeld
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit dose blister strip contains 16 microgram tiotropium bromide
monohydrate equivalent to
13 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the
Elpenhaler) is 10 microgram
tiotropium.
Excipient with known effect:
Each unit dose blister strip contains 11.86 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White inhalation powder.
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 blister strip
once daily with the Elpenhaler device at the same time of day.
The recommended dose should not be exceeded.
Tiotropium blister strips are only for inhalation and not for oral
intake. Tiotropium blister strips
must not be swallowed. Tiotropium should only be inhaled with the
Elpenhaler device. The
Elpenhaler device should be kept inside the sachet to be protected
from moisture and should only
be removed immediately before first use.
Special populations
Geriatric patients can use tiotropium at the recommended dose.
Renally impaired patients can use tiotropium 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 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 in children and adolescents has
not been established. No