Favynd 18mcg inhalation powder, hard capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIOTROPIUM BROMIDE

Available from:

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

ATC code:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE 18 µg

Pharmaceutical form:

INHALATION POWDER, HARD CAPSULE

Composition:

TIOTROPIUM BROMIDE 18 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2015-07-08

Patient Information leaflet

F1/IE/MT/PI/1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FAVYND 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 Favynd 18 microgram is and what it is used for
2.
What you need to know before you use Favynd 18 microgram
3.
How to use Favynd 18 microgram
4.
Possible side effects
5.
How to store Favynd 18 microgram
6.
Contents of the pack and other information
1.
WHAT FAVYND 18 MICROGRAM IS AND WHAT IT IS USED FOR
Favynd 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 Favynd 18 microgram every day and not
only when you have
breathing problems or other symptoms of COPD.
Favynd 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 Favynd 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 Favynd
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.
2.
WHAT YOU NEED TO K

Summary of Product characteristics

F1/MT/SPC/1
FAVYND
 18 MICROGRAM INHALATION
POWDER, HARD CAPSULE
Malta
tiotropium bromide monohydrate
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Favynd 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.
F1/MT/SPC/1
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 indicatio