Spiriva

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 Spiriva. It does not contain all the information that is known about Spiriva. 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 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. It belongs to a group of medicines called anticholinergics.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.

Before you take Spiriva

When you must not take it

Do not take Spiriva if you have an allergy to:
any medicine containing tiotropium bromide
any of the ingredients listed at the end of this leaflet
any medicine containing atropine
any other anticholinergic medicines.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine to treat a sudden attack of breathlessness, wheezing or coughing.
You will need a different type of medicine.
Do not give this medicine to children or adolescents (below the age of 18 years).
There is no experience with its use in children under 18 years of age.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have, or have had, any of the following medical conditions:
high pressure in the eye (glaucoma)
kidney or liver problems
problems with your prostate gland
problems with passing urine.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved. Spiriva is not generally recommended for use in pregnant women, unless the benefits of treatment outweigh the risk to the unborn baby.
If you have not told your doctor about any of the above, tell him/her before you start taking Spiriva.
Do not allow the powder to enter into the eyes. Should this occur, immediately flush your eyes with cold tap water for several minutes.
Take this medicine only with the HandiHaler® device.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Spiriva may interfere with each other. These include other anticholinergic medicines used to treat COPD such as ipratropium bromide.
These medicines may be affected by Spiriva or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Spiriva

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The recommended dose for adults is 1 capsule to be inhaled, once a day.

How to take it

Inhale the powder in the capsules only using the HandiHaler device.
Do not swallow the capsules.
Do not open the capsules.
If you open the capsules, the small amount of powder inside may be lost, or you may accidentally get the powder in your eyes.
Use each strip of 5 capsules within 5 days of first opening the strip.
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. Pierce the capsule only once using the HandiHaler device.
If you pierce it more than once, 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.
Do not allow the powder to enter into the eyes. Should this occur, immediately flush your eyes with cold tap water for several minutes.
If you have any problems inhaling Spiriva using the HandiHaler device ask your doctor or pharmacist for advice.

When to take it

Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice, or go to Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Spiriva. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include fast or irregular heart beat, blurred vision, nausea, stomach pain, dry mouth, constipation and difficulty passing urine.

While you are taking Spiriva

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Spiriva.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
It is very important to follow the Directions for Use carefully.
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 taking 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 taking this medicine, tell your doctor immediately.
If you are a smoker, your doctor or pharmacist can advise you on the steps to take to quit smoking.

Things you must not do

Do not take Spiriva to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Spiriva affects you.
This medicine may cause dizziness or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Spiriva.
This medicine helps most people with COPD, but it can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
dry mouth
sore mouth or throat
oral thrush
hoarse voice
nose bleeds
cough
dizziness
constipation
trouble sleeping
sinusitis, a feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache, fever, stuffy nose and loss of the sense of smell.
These are mild side effects of the medicine, and usually short-lived.
Tell your doctor as soon as possible if you notice any of the following:
blurred vision
high pressure in the eye (glaucoma)
difficulty in swallowing
heartburn
difficulty in passing urine
pain while passing urine, increased need and frequency in passing urine
a worsening of breathing problems (induced by the inhalation process).
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Emergency at your nearest hospital:
severe pain in the stomach with bloating, gut cramps and vomiting
changes in heart rate (fast, slow or irregular), palpitations
allergic reaction (shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin).
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some people.

After taking Spiriva

Cleaning

Follow the instructions under the heading Directions for Use at the end of this leaflet.

Storage

Keep your capsules in the pack until it is time to take them.
If you take the capsules out of the pack they may not keep well.
Keep your capsules in a cool, dry place where the temperature stays below 25°C. Do not store your capsules in the freezer.
Do not store Spiriva or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

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 a white powder.
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.
Spiriva is available in cartons containing 10*, 30 or 60* capsules and hospital packs containing 150* or 300* capsules. Combination packs of 10, 30* and 150* capsules with the HandiHaler device are also available.
*Not currently distributed in Australia.
The HandiHaler device is available separately from your pharmacist and should be replaced every twelve months.

Ingredients

Spiriva contains 18 micrograms of tiotropium (equivalent to tiotropium bromide monohydrate 22.5 micrograms) as the active ingredient.
It also contains 5.5 milligrams of lactose (which contains milk protein).

Supplier

Spiriva is supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
78 Waterloo Road
NORTH RYDE NSW 2113
Spiriva is supplied in New Zealand by:
Boehringer Ingelheim (NZ) Limited
Auckland
® = Registered Trademark
© Boehringer Ingelheim Pty Limited 2013
This leaflet was updated in March 2013

Australian Registration Number:

AUST R 81525