Braltus 10microgram inhalation powder capsules with Zonda inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tiotropium bromide

Available from:

Teva UK Ltd

ATC code:

R03BB04

INN (International Name):

Tiotropium bromide

Dosage:

10microgram

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010200; GTIN: 5017007032465

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1. What Braltus is and what it is used for
2. What you need to know before you take
Braltus
3. How to take 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 take 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 take it once a day.
This medicine should not be used as a rescue
therapy for the treatment of unexpected
tightness of the chest, coughing or sudden
attacks of breathlessness or wheezing. Please
use a fast-acting ‘reliever’ (rescue) inhaler, such
as salbutamol instead. Please keep this
‘reliever’ inhaler with you at all times.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BRALTUS
DO NOT TAKE BRALTUS:
− if you are allergic (hypersensitive) to
tiotropium or any of the other ingredients of
this medicine (listed in section 6)
− if you are allergic (hypersensitive) to atropine
or substances related to it, e.g. ipratropium
or oxitropium
− if you are allergic (hypersensitive) to lactose
or any other sugars
WARNINGS AND PRECAUTIONS
Talk to yo

Summary of Product characteristics

OBJECT 1
TIOTROPIUM (BRALTUS) 10MCG INHALATION POWDER
Summary of Product Characteristics Updated 01-Dec-2016 | Teva UK
Limited
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