SPIRIVA tiotropium 18 micrograms powder for inhalation (in capsule) blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tiotropium, Quantity: 18 microgram (Equivalent: tiotropium bromide monohydrate, Qty 22.5 microgram)

Tilgjengelig fra:

Boehringer Ingelheim Pty Ltd

Legemiddelform:

Inhalation, powder for

Sammensetning:

Excipient Ingredients: lactose monohydrate

Administreringsrute:

Inhalation

Enheter i pakken:

150 & 300 capsules (Hospital pack), 10, 30 & 60 capsules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

SPIRIVA is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). SPIRIVA is indicated for the prevention of COPD exacerbations.

Produkt oppsummering:

Visual Identification: Light green, opaque hard gelatin capsules containing a white powder, with product code (TI 01) and company logo printed in black on the capsule.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2002-05-30

Informasjon til brukeren

SPIRIVA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SPIRIVA?
Spiriva capsules contain the active ingredient tiotropium. Spiriva is
used to make breathing easier for people with chronic obstructive
pulmonary disease (COPD).
For more information, see Section 1. Why am I using Spiriva? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SPIRIVA?
Do not use if you have ever had an allergic reaction to tiotropium,
atropine, medicines like atropine (e.g. ipratropium or oxitropium) or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Spiriva? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Spiriva and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SPIRIVA?
•
The recommended dose for adults is 1 capsule to be inhaled, once a
day.
•
Use the HandiHaler device to inhale the powder in the capsules
•
Do not swallow the capsules.
More instructions can be found in Section 4. How do I use Spiriva? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SPIRIVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Spiriva.
•
Tell your doctor immediately if your breathing becomes more difficult
while you are taking Spiriva.
THINGS YOU
SHOULD NOT DO
•
Do not use Spiriva more frequently than once daily.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Spiriva affects you.
•
Spiriva may cause dizziness or blurred vision in some people.
LOOKING AFTER
YOUR MEDICINE
•
Keep your capsules in a cool, dry

Preparatomtale

SPIRIVA PI0101-14
1
AUSTRALIAN PRODUCT INFORMATION – SPIRIVA (TIOTROPIUM) POWDER FOR
INHALATION
(IN CAPSULE)
1 NAME OF THE MEDICINE
tiotropium (as tiotropium bromide monohydrate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatine SPIRIVA capsule contains 18 micrograms tiotropium,
equivalent to
22.5 micrograms tiotropium bromide monohydrate and the excipient
lactose monohydrate
(which contains milk protein).
Excipients with known effect:
This product contains 5.5 mg of lactose monohydrate per capsule.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
SPIRIVA capsules are light green in colour, with the product code (TI
01) and company logo
printed on the capsule. The capsules contain a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPIRIVA is indicated for the long term maintenance treatment of
bronchospasm and
dyspnoea associated with chronic obstructive pulmonary disease (COPD).
SPIRIVA is
indicated for the prevention of COPD exacerbations.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dosage of SPIRIVA is inhalation of the contents of one
capsule, once daily
with the HandiHaler device, at the same time each day (_see HandiHaler
Instructions for Use_).
SPIRIVA capsules must not be swallowed.
SPECIAL POPULATIONS
Elderly patients can use SPIRIVA at the recommended dose.
Renally impaired patients can use SPIRIVA at the recommended dose.
However, as with all
predominantly renally excreted drugs, SPIRIVA use should be monitored
closely in patients
with moderate to severe renal impairment.
Hepatically impaired patients can use SPIRIVA at the recommended dose.
PAEDIATRIC POPULATION
There is no experience with SPIRIVA in infants and children and
therefore should not be used
in this age group.
4.3 CONTRAINDICATIONS
SPIRIVA is contraindicated in patients with a history of
hypersensitivity to tiotropium bromide,
atropine or its derivatives, e.g. ipratropium or oxitropium or to any
other component of this
product (see Section 6.1 List of excipie