Braltus 10 microgram per delivered dose inhalation powder, hard capsule

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Tiotropium bromide

Fáanlegur frá:

Teva B.V.

ATC númer:

R03BB; R03BB04

INN (Alþjóðlegt nafn):

Tiotropium bromide

Skammtar:

10 microgram(s)

Lyfjaform:

Inhalation powder, hard capsule

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Anticholinergics; tiotropium bromide

Leyfisstaða:

Marketed

Leyfisdagur:

2016-07-08

Upplýsingar fylgiseðill

1
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 not be used as a rescue ther

Vara einkenni

Health Products Regulatory Authority
23 June 2022
CRN00CZ0Z
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
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).
_Paediatric population_
Braltus should not be used in children or