SPIRIVA 18 microgram, inhalation powder, hard capsule

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

TIOTROPIUM BROMIDE

Beschikbaar vanaf:

Boehringer Ingelheim International GmbH Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

ATC-code:

R03BB04

INN (Algemene Internationale Benaming):

TIOTROPIUM BROMIDE 18 µg

farmaceutische vorm:

INHALATION POWDER, HARD CAPSULE

Samenstelling:

TIOTROPIUM BROMIDE 18 µg

Prescription-type:

POM

Therapeutisch gebied:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Autorisatie-status:

Authorised

Autorisatie datum:

2011-05-10

Bijsluiter

1
PACKAGE LEAFLET
2
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 MICROGAM 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 once a day. For

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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.
3
_Cystic fibrosis _
The safety and efficacy of Spiriva 18 microgram in children and
adolescents has not been estab