Braltus Inhalation Powder, Capsule 10mcg/dose

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

TIOTROPIUM BROMIDE

Fáanlegur frá:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC númer:

R03BB04

INN (Alþjóðlegt nafn):

TIOTROPIUM BROMIDE 0.016 mg

Lyfjaform:

INHALATION POWDER, HARD CAPSULE

Samsetning:

TIOTROPIUM BROMIDE 0.016 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Leyfisstaða:

Withdrawn

Leyfisdagur:

2016-07-18

Upplýsingar fylgiseðill

Page 1 of 11
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRALTUS 10 MICROGRAM PER DELIVERED DOSE 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Braltus is and what it is used for
2.
What you need to know before you use Braltus
3.
How to use Braltus
4.
Possible side effects
5.
How to store Braltus
6.
Contents of the pack and other information
1.
WHAT BRALTUS
IS AND WHAT IT IS USED FOR
Braltus contains the active substance tiotropium. Tiotropium 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
this medicine every day
and not only when you have breathing problems or other symptoms of
COPD.
Braltus 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 this medicine 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 this medicine 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.
This medicine should

Vara einkenni

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 15
1.
NAME OF THE MEDICINAL PRODUCT
Braltus 10 microgram per delivered dose inhalation powder, hard
capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 16 micrograms of tiotropium bromide, equivalent
to 13 micrograms of
tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the Zonda
inhaler) is 10 micrograms of
tiotropium per capsule.
Excipient with known effect
Each capsule contains 18 milligrams lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Colourless and transparent, size 3 capsules, containing white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Braltus is indicated as a maintenance bronchodilator treatment to
relieve symptoms in patients with
chronic obstructive pulmonary disease (COPD).
Braltus is indicated for use in adults.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Route of administration: Inhalation use.
_Recommended Dose _
Adults 18 years of age and older:
Inhalation of the contents of
ONE
capsule once daily with the Zonda inhaler.
Inhalation should be at the same time of day each day.
The recommended dose should not be exceeded.
The delivered dose of a single capsule (10 micrograms) is sufficient
and is the standard dose for
treatment with Braltus.
Braltus capsules are for inhalation only; they must not be swallowed.
Braltus capsules must only be inhaled with the Zonda inhaler.
_ _
_Special populations_
Elderly patients can use tiotropium bromide at the recommended dose.
Patients with mild renal impairment (creatinine clearance >50 ml/min)
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).
Page 3 of 15
_Paediatric population _
Braltus should not be used in children or adolescents under 18