SPIRIVA RESPIMAT tiotropium 2.5 micrograms/actuation solution for inhalation cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tiotropium bromide monohydrate, Quantity: 3.1235 microgram/actuation (Equivalent: tiotropium, Qty 2.5 microgram/actuation)

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

Tiotropium bromide monohydrate

Pharmaceutical form:

Inhalation, conventional

Composition:

Excipient Ingredients: purified water; hydrochloric acid; disodium edetate; benzalkonium chloride

Administration route:

Inhalation

Units in package:

60 actuations (1 cartridge) + Respimat inhaler (inhalation device) starter pack, 60 actuations (1 cartridge) + Respimat inhaler

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

COPD: SPIRIVA RESPIMAT is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). SPIRIVA RESPIMAT is indicated for the prevention of COPD exacerbations.,Asthma: SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-05-02

Patient Information leaflet

SPIRIVA
® RESPIMAT
®
_SOLUTION FOR INHALATION_
_tiotropium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Spiriva Respimat.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Spiriva
Respimat against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SPIRIVA
RESPIMAT IS USED FOR
Spiriva Respimat is used to make
breathing easier for patients with:
•
chronic obstructive pulmonary
disease (COPD)
•
asthma.
When used to treat asthma you
should use Spiriva Respimat in
addition to other medicines called
inhaled corticosteroids.
COPD is a serious lung condition
that can cause difficulty in breathing
and constant coughing. The term
COPD is associated with the
conditions chronic bronchitis and
emphysema. Spiriva Respimat helps
to improve your COPD condition and
to prevent exacerbations (periodic
worsening of symptoms) from
occurring.
Asthma is a serious lung condition
where the lining of the lungs
becomes inflamed (red and swollen),
making it difficult to breathe. This
may be due to an allergy to house
dust mites, smoke or other irritants.
Spiriva Respimat improves breathing
by relaxing the breathing tubes or air
passages that carry air to and from
the lungs.
Spiriva Respimat contains the active
ingredient tiotropium bromide
monohydrate. It belongs to a group
of medicines called anticholinergics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT

Summary of Product characteristics

SPIRIVA RESPIMAT PI0138-04
1
AUSTRALIAN PRODUCT INFORMATION – SPIRIVA
® RESPIMAT
®
TIOTROPIUM SOLUTION
FOR INHALATION
1 NAME OF THE MEDICINE
tiotropium (as tiotropium bromide monohydrate)
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Each puff contains tiotropium 2.5 micrograms, equivalent to tiotropium
bromide monohydrate
3.1 micrograms.
SPIRIVA RESPIMAT cartridges contain a clear, colourless, solution for
inhalation filled into a
plastic container which is inside an aluminium cylinder (cartridge)
for use with the RESPIMAT
inhaler. The SPIRIVA RESPIMAT inhaler has a green-coloured cap.
SPIRIVA RESPIMAT
is for oral inhalation only.
Excipients with known effect:
SPIRIVA RESPIMAT
contains 0.0011 mg benzalkonium chloride in each actuation.
For the full list of excipients, see Section 6.1 List of excipients.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COPD
SPIRIVA RESPIMAT is indicated for the long term maintenance treatment
of bronchospasm
and dyspnoea associated with chronic obstructive pulmonary disease
(COPD). SPIRIVA
RESPIMAT is indicated for the prevention of COPD exacerbations.
ASTHMA
SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator
treatment in patients
aged 6 years and older with moderate to severe asthma.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dosage of tiotropium using the SPIRIVA RESPIMAT is 5
micrograms. This
is administered as two puffs once daily at the same time each day (see
_RESPIMAT inhaler _
_Instructions for Use_).
The recommended dose should not be exceeded.
In the treatment of asthma, the full benefits will be apparent after
several doses of SPIRIVA
RESPIMAT.
Paediatric population:
In asthma, the recommended dosage of tiotropium using the SPIRIVA
RESPIMAT in patients
6 to 17 years of age is 5 micrograms. This is administered as two
puffs once daily from the
RESPIMAT inhaler, at the same time each day (see _RESPIMAT inhaler
Instructions for Use_).
SPECIAL POPULATIONS:
Elderly patients can use SPIRIVA RESPIMAT at the recommend