Powder for Inhalation
Tiotropium bromide
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Spiriva is used for
Spiriva is used to make breathing easier for people with chronic obstructive pulmonary disease (COPD). This helps to improve your condition and to prevent exacerbations (periodic worsening of symptoms) from occurring.
Spiriva improves breathing by relaxing the breathing tubes or air passages that carry air to and from the lungs. It begins to act within 30 minutes after use and the effect should last a full day.
Spiriva contains the active ingredient tiotropium bromide. This medicine is known as an anticholinergic medicine.
Before you use Spiriva
When not to use Spiriva
Only use Spiriva if it has been prescribed for you by a doctor.
Never give it to someone else even if their symptoms seem to be the same as yours.
Do not use Spiriva if you are allergic to it or to any of the ingredients.
These ingredients are listed in full at the end of this leaflet (See Ingredients).
In some cases you should not use Spiriva if you are allergic to certain other medicines.
You must tell your doctor if you are allergic to atropine or any other anticholinergic medicines.
If you are uncertain as to whether you have these allergies you should raise your concerns with your doctor.
You should never use Spiriva after the EXPIRY DATE on the blister strips or carton.
Before you start to use Spiriva
It is essential that your doctor knows your medical history before prescribing Spiriva.
Before using Spiriva, you must tell your doctor if you have, or have had, any of the following conditions:
high pressure in the eye (glaucoma)
kidney problems
problems with your prostate gland
problems with passing urine
If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor.
Before taking Spiriva you must tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription.
In particular you must tell your doctor if you are taking:
other anticholinergic medicines such as ipratropium.
Pregnancy
Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication.
Spiriva is not generally recommended for use in pregnant women, unless the benefits of treatment outweigh the risk to the unborn baby.
Breastfeeding
Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication.
It is not known whether Spiriva passes into breast milk in breastfeeding women. Your doctor will discuss the risks and benefits of using Spiriva if you intend to breastfeed.
Children
Spiriva should not be used in children.
Using Spiriva
How to use Spiriva
The powder in the capsules must only be inhaled using the HandiHaler device.
Use each strip of 5 capsules within 5 days of first opening the strip.
Please read the Directions for Use at the end of this leaflet for instructions on how to use Spiriva capsules with the HandiHaler device.
Follow the Directions for Use carefully. Using the HandiHaler device, pierce the capsule only once.
If you pierce it more often, the capsule may break and pieces of gelatin from the capsule shell, small enough to pass the sieve, may be inhaled into your mouth or throat. Gelatin is not harmful and small particles swallowed or inhaled will be digested or absorbed and are not expected to cause undesirable effects.
If you have any problems inhaling Spiriva using the HandiHaler device ask your doctor or pharmacist for advice.
Never allow Spiriva powder to come into contact with your eyes. Should this occur, immediately flush your eyes with cold tap water for several minutes.
Recommended Dose
The recommended dose for adults is 1 capsule to be inhaled, once a day.
If you forget to inhale a dose
It is important to use Spiriva as directed.
If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time.
Do not take a double dose to make up for the dose that you missed.
How long to take Spiriva
Spiriva helps control your condition, but does not cure it. Therefore you must use Spiriva every day. Continue using the medicine for as long as your doctor or pharmacist tells you.
Do not stop using it unless your doctor or pharmacist tells you to - even if you feel better.
Overdose
Seek medical advice if you have used more than the recommended or prescribed dose of Spiriva and you experience signs of overdose as listed below.
Advice can be provided by a doctor, pharmacist or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766).
Signs of overdose may include fast or irregular heart beat, blurred vision, nausea, stomach pain, dry mouth, constipation and difficulty passing urine.
While you are using Spiriva
Things you must do
It is very important to follow the Directions for Use carefully and avoid contact of the powder with the eyes.
Contact your doctor immediately if you experience eye pain or discomfort, or any disturbances with your sight (blurred vision, visual halos or coloured images) during or after using Spiriva.
This is because there have been isolated reports of narrow-angle glaucoma with the use of Spiriva.
If your breathing becomes more difficult while you are using Spiriva, tell your doctor immediately.
If you are a smoker, your doctor or pharmacist can advise you on the steps to take to quit smoking.
Tell your doctor or pharmacist if you begin taking any other medicine while you are using Spiriva.
This applies to all medicines obtained with or without a doctor's prescription.
Effects on ability to drive or operate machinery
Be careful when driving or operating machinery until you know how Spiriva affects you.
Spiriva may cause dizziness or blurred vision in some people. Make sure you know how you react to Spiriva before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.
Side effects
You should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. Your doctor has weighed the risks of you taking Spiriva against the benefits they expect it will have for you.
Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of taking this medicine.
The more frequently reported side effects of Spiriva are:
dry mouth
cough
fast heart beat
blurred vision
high pressure in the eye (glaucoma)
sore mouth or throat
Dizziness has also been reported.
Less frequently reported side effects of Spiriva include:
constipation
difficulty in passing urine
pain while passing urine, increased need and frequency in passing urine
itching, skin rash or allergic reactions (swollen tongue and lips, mouth ulcers and rash on the face)
a change in heart rate
heartburn
oral thrush
hoarse voice
nose bleeds
trouble sleeping
As with other inhaled medicines, a worsening of breathing problems (induced by the inhalation process) may occur.
Tell your doctor as soon as possible if you experience any side effects during or after using Spiriva, so that these may be properly assessed.
In addition, unexpected effects, not listed above, can occur with any medicine.
You should tell your doctor or pharmacist if you notice anything unusual, during or after using Spiriva.
After using Spiriva
Care and cleaning
Follow the instructions under the heading Directions for Use at the end of this leaflet.
Storage
Spiriva should be kept in a cool, dry place where the temperature stays below 25°C.
Do not store Spiriva in the bathroom or near the sink.
Do not leave Spiriva in the car or on window sills.
Heat and dampness can destroy the medicine.
Do not store Spiriva in the freezer.
Keep your Spiriva capsules where children cannot reach them.
Disposal
If your doctor tells you that you do not need Spiriva anymore, the unused medicine should be returned to your pharmacist so that it can be disposed of safely.
Product Description
What Spiriva is
Spiriva is the brand name of your medicine. It comes as a powder inside a capsule. You must use the HandiHaler device in order to inhale powder from the capsule.
Spiriva capsules contain a white powder. Spiriva capsules are light green with the product code "TI 01" and the Boehringer Ingelheim logo printed in black ink on the capsules.
Spiriva capsules contain only a small amount of powder, which means that the capsule is only partially filled. The amount of powder in each capsule is equivalent in size to the tip of a matchstick.
Each pack contains 30 capsules.
Spiriva capsules are identified by a specific Australian Registration Number and this appears on the pack (AUST R 81525).
The HandiHaler device is available separately from your pharmacist.
Ingredients
Each capsule of Spiriva contains tiotropium 18 micrograms (equivalent to tiotropium bromide monohydrate 22.5 micrograms).
Spiriva also contains 5.5 milligrams of lactose (which contains milk protein).
Manufacturer
Spiriva is supplied in Australia by:
Boehringer Ingelheim Pty Limited#
(ABN 52 000 452 308)
78 Waterloo Road
NORTH RYDE NSW 2113
Tel: 1800 116 113
Pfizer Australia Pty Ltd
(ABN 50 008 422 348)
38-42 Wharf Road
WEST RYDE NSW 2114
#Sponsor
Spiriva is supplied in New Zealand by:
Boehringer Ingelheim (NZ) Limited
Auckland
This leaflet was revised on 1 July 2010
® = Registered Trademark
© Boehringer Ingelheim Pty Limited 2010
