capsules for inhalation
Glycopyrronium bromide (glycopyrrolate)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Seebri Breezhaler.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date
information on the medicine. You can also download the most up-to-date leaflet from
www.novartis.com.au.
Those updates may contain important information about the medicine and its use of
which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having
Seebri Breezhaler against the benefits they expect it will have for you.
If you have any concerns about having this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Seebri Breezhaler is used for
Seebri capsules are for the treatment of chronic obstructive pulmonary disease, also
called COPD. COPD is a serious lung condition that can cause difficulty in breathing,
and constant coughing. Symptoms of COPD include shortness of breath, cough, chest
discomfort and coughing up phlegm.
Seebri capsules for inhalation belong to a group of medicines called bronchodilators.
These medicines are used to keep the air passages in the lungs open and make breathing
easier.
Seebri Breezhaler block tightening of these muscles in the lungs, making it easier
for air to get in and out of the lungs.
Seebri capsules for inhalation contain the active ingredient, glycopyrronium bromide
(glycopyrrolate) in a capsule form.
The capsules are for oral inhalation only. The powder from the capsule is inhaled
(breathed into the lungs), using the Breezhaler® inhalation device provided with the medicine.
Ask your doctor if you have any questions about why Seebri Breezhaler has been prescribed
for you.
This medicine is only available with a doctor's prescription.
It is not addictive.
Before you use Seebri Breezhaler
When you must not use it
Do not use Seebri Breezhaler if you have ever had an allergic reaction to glycopyrronium
bromide (the active ingredient) or to any of the other ingredients listed at the end
of this leaflet.
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.
If this applies to you, tell your doctor without using Seebri Breezhaler.
If you think you may be allergic, ask your doctor for advice.
Do not breast-feed while you are using this medicine.
It is not known if the active ingredient passes into the breast milk and could affect
your baby.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to use it
Tell your doctor if you have any of the following medical conditions:
you have kidney problems
you have an eye problem called narrow-angle glaucoma
you have difficulty passing urine
Your doctor may want to take special precautions if you have any of the above conditions.
Seebri Breezhaler is used as a maintenance treatment for your COPD. Do not use Seebri
Breezhaler to treat a sudden attack of breathlessness or wheezing.
Tell your doctor if you are pregnant or intend to become pregnant.
Seebri is not recommended for use during pregnancy. If it is necessary for you to
use this medicine during pregnancy, your doctor will discuss with you the benefits
and risks involved.
There are a number of other medicines that work in the same way as Seebri and that
are commonly prescribed. Some of these similar medicines that can be used to treat
your lung disease include ipratropium, oxitropium or tiotropium (also called anticholinergics).
Please speak to your doctor or pharmacist if you still have any of these medicines
because it may not be intended that you will use them while you are taking Seebri.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines
that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Seebri may interfere with each other. This includes medicines similar
to Seebri used for your lung disease. It's not recommended to use Seebri with anticholinergics
such as ipratropium, oxitropium or tiotropium. You may need to take different amounts
of your medicines or you may need to take different medicines. Your doctor and pharmacist
have more information.
If you have not told your doctor about any of these things, tell him/her before you
start using Seebri Breezhaler.
How to use Seebri Breezhaler
You may have been given a treatment plan by your doctor to help you manage your COPD
and to know what to do when it worsens. Make sure that you understand this plan by
talking to your doctor and pharmacist about it. In particular, do not stop other medications
that are used to treat COPD even if you feel well. Only stop other prescribed medications
on medical advice.
Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label or in the carton, ask your
doctor or pharmacist for help.
How much to use
The dose for adults is the inhalation (puff) of the content of one capsule each day,
every day. There is no gain to be had from exceeding this dose. Take your puff at
the same time each day to help minimise your symptoms throughout the day and night.
It will also help you remember to use your medicine.
How to use the Breezhaler
Carefully read the instructions and follow the diagrams inside the carton that show
you how to use the Breezhaler properly.
Make sure you understand how to use the device properly. If you are not sure, ask
your doctor or pharmacist for help.
How long to use it
Continue to use this medicine for as long as your doctor tells you to.
If it helps your breathing problems, your doctor may want you to keep using it for
a long time. This medicine helps to control your condition but it does not cure it.
You will need to use other medications as well and this will be outlined in your COPD
management plan.
If you still smoke, you should stop. If have not taken advice about an exercise program,
consider asking for it.
If you forget to use it
If it is almost time for your next dose, skip the one you missed and use the next
dose when you are meant to.
Otherwise, use it as soon as you remember, and then go back to using it as you would
normally.
Do not use a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to use your medicine, ask your pharmacist for
some hints.
If you use too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)
for advice, or go to Accident and Emergency at your nearest hospital if you think
that you or anyone else may have used too much Seebri. Do this even if there are no
signs of discomfort or poisoning.
While you are using Seebri Breezhaler
Things you must do
Only use the inhalation device contained in this pack.
Use this medicine exactly as your doctor has prescribed. Try not to miss any doses
and use it even if you feel well.
If you do not follow your doctor's instructions, you may not get relief from your
breathing problems or you may have unwanted side effects.
If you find that the usual dose of Seebri Breezhaler is not giving as much relief
as before, or does not last as long as usual, contact your doctor so that your condition
can be checked.
This is important to ensure your COPD is controlled properly.
During treatment with SEEBRI BREEZHALER:
TELL YOUR DOCTOR IMMEDIATELY if you experience signs and symptoms of prostatic hyperplasia
or bladder-neck obstruction (e.g., difficulty passing urine, painful urination).
STOP TAKING SEEBRI BREEZHALER AND TELL YOUR DOCTOR IMMEDIATELY if you experience tightness
of the chest, coughing, wheezing or breathlessness directly after using Seebri Breezhaler
(signs of bronchospasm)
STOP TAKING SEEBRI BREEZHALER AND TELL YOUR DOCTOR IMMEDIATELY if you experience eye
pain or discomfort, temporary blurring of vision, visual halos or coloured images
in association with red eyes; these may be signs of an acute attack of narrow-angle
glaucoma.
If you become pregnant while using this medicine, tell your doctor.
Your doctor can discuss with you the risks of using it while you are pregnant.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using Seebri Breezhaler.
Tell any other doctor, dentist or pharmacist who treats you that you are using this
medicine.
Things you must not do
Do not exceed the recommended daily dose - it will not help you to do this. Instead,
check your COPD management plan and seek medical attention. Do not swallow the capsules.
Do not take any other medicines for your breathing problems without checking with
your doctor.
Do not give this medicine to anyone else, even if their condition seems similar to
yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Do not use the Breezhaler inhaler after 30 days of use.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert
until you know how Seebri affects you.
This medicine may cause dizziness in some people. Make sure you know how you react
before you drive a car, operate machinery, or do anything else that could be dangerous.
If you are dizzy, do not drive.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using Seebri Breezhaler.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by these lists of possible side effects. You may not experience
any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following side effects and they worry you:
Dry mouth
Nausea, vomiting, diarrhoea and abdominal pain (possible symptoms of gastroenteritis)
Difficulty sleeping
Stomach discomfort after meal (possible symptoms of dyspepsia)
Dental caries
Pain in extremities (e.g. arms or legs)
Pain in muscles, bones or joints of the chest
Rash
Tiredness
Weakness
Feeling of pressure or pain in the cheeks and forehead (possible symptoms of sinus)
Cough with sputum
Throat irritation
Painful and frequent urination (possible symptoms of cystitis)
Difficulty and pain when passing urine (possible symptoms of dysuria)
Palpitations
Nose bleeds
Runny or stuffy nose, sneezing (rhinitis), sore throat
Musculoskeletal pain
Neck pain
Numbness
Itching
Voice alteration (hoarseness)
Some elderly patients above 75 years of age have also experienced headache and urinary
tract infection.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if any of the following happen:
Irregular heart beat (possible signs of atrial fibrillation)
Swelling mainly of the tongue, lips, face and throat (possible signs of angioedema)
Difficulty in breathing or swallowing, swelling of tongue, lips and face, skin rash,
itching and hives (signs of allergic reactions)
Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)
High level of blood sugar (hyperglycemia; typical symptoms include excessive thirst
or hunger and frequent urination)
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.
Some side effects may only be found when your doctor orders blood tests from time
to time.
After using Seebri Breezhaler
Cleaning and storage
Follow the instructions in the carton on how to properly clean and take care of your
Seebri Breezhaler.
Store it in a cool dry place away from moisture.
Do not store the device or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Dispose of each Breezhaler inhaler after 30 days of use.
Keep this medicine where children cannot see or 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 using this medicine or the expiry date has passed,
ask your pharmacist how to dispose of it properly.
Product description
What it looks like
Glycopyrronium bromide (glycopyrrolate) 50 microgram capsules
Clear orange coloured hard capsules with black imprints. The capsules are marked with
"GPL 50" and a black company logo. The capsules come in foil packs containing 30 capsules
in a cardboard carton.
Breezhaler
A white plastic Breezhaler inhalation device is also supplied in the pack.
Ingredients
Active Ingredient
Each capsule contains 50 micrograms of glycopyrronium as glycopyrronium bromide (glycopyrrolate).
Other ingredients
Seebri capsules also contain lactose and magnesium stearate.
Sponsor
Seebri Breezhaler is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1-800-671-203
Web site: www.novartis.com.au
® = Registered Trademark
This leaflet was prepared in March 2018.
Australian Registration Numbers.
Seebri Breezhaler 50 microgram: AUST R 191517
(see090318c.doc) based on PI (see090318i.doc)