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 PAVTIDE ACCUHALER?
PAVTIDE ACCUHALER contains the active ingredients fluticasone propionate and salmeterol
xinafoate. PAVTIDE ACCUHALER is used to help with asthma and chronic obstructive pulmonary
disease (COPD) in people who need regular treatment.
2. What should I know before I use PAVTIDE ACCUHALER?
Do not use if you have ever had an allergic reaction to any medicine containing fluticasone
propionate or salmeterol xinafoate, lactose monohydrate or milk proteins, 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.
3. What if I am taking other medicines?
Some medicines may interfere with PAVTIDE ACCUHALER and affect how it works.
4. How do I use PAVTIDE ACCUHALER?
Follow dosage directions given to you by your doctor or pharmacist and continue taking
it for as long as your doctor tells you.
PAVTIDE ACCUHALER should be inhaled into your lungs through the mouth.
5. What should I know while using PAVTIDE ACCUHALER?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using PAVTIDE ACCUHALER.
If you are going to have surgery, tell the surgeon or anesthetist that you are taking
this medicine.
Tell your doctor if you become, or are trying to become, pregnant.
Tell your doctor if you are using PAVTIDE ACCUHALER, if you have any blood tests.
Contact your doctor if you experience a change in your vision.
Keep all of your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not stop using this medicine suddenly or change the dosage without checking with
your doctor.
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Driving or using machines
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This medicine is not expected to affect your ability to drive a car or operate machinery.
It is prudent to be careful driving or operating machinery until you know how PAVTIDE
ACCUHALER affects you.
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Looking after your medicine
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Keep PAVTIDE ACCUHALER in a dry place where the temperature stays below 30°C away
from direct heat or sunlight.
Keep it where children cannot reach it.
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6. Are there any side effects?
The following common side effects may occur when taking PAVTIDE ACCUHALER; soreness
in the mouth, throat or tongue, hoarseness, headache, muscle cramps, pain in joints,
increase in heart rate, pneumonia. If your breathing or wheezing gets worse straight
after using PAVTIDE ACCUHALER, stop using it immediately and tell your doctor as soon
as possible.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredients: Fluticasone propionate/Salmeterol xinafoate
Consumer Medicine Information (CMI)
This leaflet provides important information about using PAVTIDE ACCUHALER. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using PAVTIDE ACCUHALER.
Where to find information in this leaflet:
1. Why am I using PAVTIDE ACCUHALER?
PAVTIDE ACCUHALER contains the active ingredients fluticasone propionate and salmeterol
xinafoate.
Fluticasone propionate belongs to a group of medicines known as corticosteroids, frequently
called 'steroids'. They are not 'anabolic steroids' which are the steroids sometimes
misused by athletes.
Corticosteroids have an anti-inflammatory action. They reduce the swelling and irritation
in the walls of the small air passages in the lungs and so help you to breathe more
easily. Corticosteroids are used to treat asthma and COPD.
Salmeterol xinafoate is a bronchodilator. A bronchodilator keeps the breathing tubes
in your lungs open and relieves the symptoms of asthma and other chest conditions.
The effects of salmeterol xinafoate last for up to twelve hours.
When taken together regularly fluticasone propionate and salmeterol help to control
your breathing difficulties.
PAVTIDE ACCUHALER is used to help with asthma and chronic obstructive pulmonary disease
(COPD) in people who need regular treatment.
Asthma is a condition affecting the lungs. Symptoms of asthma include shortness of
breath, wheezing, chest tightness and cough. Two main causes of asthma symptoms are
bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation
(swelling and irritation of the airways).
Chronic obstructive pulmonary disease (COPD) is a long-term condition affecting the
lungs, resulting from chronic bronchitis or emphysema. Symptoms of COPD include shortness
of breath, cough, chest discomfort and coughing up phlegm. The COPD symptoms are mainly
due to bronchoconstriction (tightening of the muscle
surrounding the airways) and inflammation (swelling and irritation of the airways).
DO NOT use this medicine to treat a sudden attack of breathlessness as it will not
help you. You will need a different type of medicine, e.g. VENTOLIN (salbutamol),
which you must not confuse with PAVTIDE ACCUHALER.
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.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
PAVTIDE ACCUHALER is available as a dry powder device called an ACCUHALER.
PAVTIDE ACCUHALER: 100/50, 250/50, 500/50
2. What should I know before I use PAVTIDE ACCUHALER?
Warnings
Do not use PAVTIDE ACCUHALER if:
you are allergic to fluticasone propionate or salmeterol xinafoate, lactose monohydrate
or milk proteins or any of the ingredients listed at the end of this leaflet. Symptoms
of an allergic reaction may include wheezing or difficulty breathing, swelling of
the face, eyelids, lips/mouth, tongue or throat, chest pain or tightness, hay fever
or lumpy rash or fainting.
always check the ingredients to make sure you can use this medicine.
the expiry date (EXP) printed on the pack has passed or if the packaging is torn and
shows signs of tampering. If it has expired or is damaged, return it to your pharmacist
for disposal.
Check with your doctor if you:
have any allergies to any other medicines, foods, preservatives or dyes.
have any other medical conditions, including thrush in your mouth, tuberculosis, diabetes,
a thyroid condition, high blood pressure or a heart problem, low blood potassium levels.
are taking other steroid medicines by mouth or inhalation.
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with PAVTIDE ACCUHALER and affect how it works.
These include:
Beta-blockers used to treat high blood pressure (hypertension)
Ketoconazole used to treat fungal infection
Ritonavir used to treat HIV infection
These medicines may be affected by PAVTIDE ACCUHALER or may affect how well it works.
You may need different amounts of your medicines, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PAVTIDE ACCUHALER.
4. How do I use PAVTIDE ACCUHALER?
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
It is very important that you use the medicine regularly every day. Do not stop treatment
even if you feel better unless told to do so by your doctor.
Do not change your dose unless told to by your doctor.
If you are breathless or wheezing more often than normal, tell your doctor.
ACCUHALER
ASTHMA
Adults and adolescents 12 years and older:
Your doctor will prescribe 1 of 3 different strengths of PAVTIDE ACCUHALER for you,
depending on the severity of your condition:
PAVTIDE ACCUHALER 100/50 (100 micrograms of fluticasone propionate and 50 micrograms
of salmeterol), or
PAVTIDE ACCUHALER 250/50 (250 micrograms of fluticasone propionate and 50 micrograms
of salmeterol), or
PAVTIDE ACCUHALER 500/50 (500 micrograms of fluticasone propionate and 50 micrograms
of salmeterol).
The usual dose is one puff from your ACCUHALER twice a day.
Children 4 years and older:
The usual dose is one puff from your PAVTIDE ACCUHALER 100/50 (100 micrograms of fluticasone
propionate and 50 micrograms of salmeterol) twice a day.
No information is available on use of PAVTIDE ACCUHALER in children under 4 years
old.
COPD
Adults:
Your doctor will prescribe 1 of 2 different strengths of PAVTIDE ACCUHALER for you:
PAVTIDE ACCUHALER 250/50 (250 micrograms of fluticasone propionate and 50 micrograms
of salmeterol), or
PAVTIDE ACCUHALER 500/50 (500 micrograms of fluticasone propionate and 50 micrograms
of salmeterol).
The usual dose is one puff from your ACCUHALER twice a day.
Follow the instructions provided and use PAVTIDE ACCUHALER until your doctor tells
you to stop.
When to take PAVTIDE
Your doctor has chosen this medicine to suit you and your condition. PAVTIDE ACCUHALER
is used to help with asthma and COPD in people who need regular treatment.
It is very important that you use your PAVTIDE ACCUHALER every day, twice a day. This
will help you to keep free of symptoms throughout the day and night.
Take your medicine at about the same time(s) 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.
It does not matter if you take this medicine before or after food.
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.
How to take PAVTIDE ACCUHALER
The medicine in PAVTIDE ACCUHALER should be inhaled into your lungs.
PAVTIDE ACCUHALER must only be breathed in through the mouth.
The full instructions for using PAVTIDE ACCUHALER are given on a leaflet inside the
pack.
If you have any difficulties or do not understand the instructions, ask your doctor
or pharmacist.
Your PAVTIDE ACCUHALER is hygienically protected. It requires no maintenance and no
refilling.
Use your medicine as your doctor has told you. If you are not sure ask your doctor
or pharmacist.
After using PAVTIDE ACCUHALER
Some people find that their mouth, throat or tongue becomes sore or that their voice
becomes hoarse after inhaling this medicine. It may be helpful to rinse your mouth
with water and spit it out after using your PAVTIDE ACCUHALER. Tell your doctor but
do not stop treatment unless told to do so.
If you forget to use PAVTIDE ACCUHALER
PAVTIDE ACCUHALER should be used regularly at the same time each day If you miss
your dose at the usual time, if it is almost time for your next dose, skip the dose you missed and use your next
dose when you are meant to. Otherwise, use it as soon as you remember, then go back to using it as you would
normally.
Do not use a double dose to make up for the dose that you missed.
If you become wheezy or feel tight in the chest before the next dose is due, use a
'reliever puffer' in the usual way. You should get relief from your 'reliever puffer'
within a few minutes.
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 use too much PAVTIDE ACCUHALER
If you think that you have used too much PAVTIDE ACCUHALER, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include:
rapid heart beat
increased rate of breathing
significant muscle tremor
headache
increased blood pressure
increased blood sugar (glucose) levels
If you are not sure what to do, contact your doctor or pharmacist.
5. What should I know while using PAVTIDE ACCUHALER?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking PAVTIDE ACCUHALER.
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 anesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
It is important that all doctors treating you are aware that you are on inhaled steroids.
If your body is stressed by, for example, severe infection, surgical operation, an
accident etc, you may need steroid tablets or injections for a time.
If you become pregnant while taking this medicine, or are trying to become pregnant,
tell your doctor immediately. If you are about to have any blood tests, tell your
doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked. Tell
your doctor if, for any reason, you have not used your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Call your doctor straight away if you:
Think you may be having an allergic reaction
Experience a change in your vision
Notice any symptoms listed in section 6
Things you should not do
Do not take PAVTIDE ACCUHALER 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, or their symptoms seem similar to yours. Do not stop taking your medicine
or change the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects. If possible, your doctor will gradually reduce the amount you take each
day before stopping the medicine completely.
Driving or using machines
This medicine is not expected to affect your ability to drive a car or operate machinery.
It is prudent to be careful driving or operating machinery until you know how PAVTIDE
ACCUHALER affects you.
Looking after your medicine
Keep your PAVTIDE ACCUHALER in a dry place where the temperature stays below 30°C,
away from direct heat or sunlight.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If your breathing or wheezing gets worse straight after using your ACCUHALER, stop
using it immediately and tell your doctor as soon as possible.
Less serious side effects
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Less serious side effects
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What to do
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Mouth/throat:
hoarseness
soreness of mouth, throat or tongue
soreness in the oesophagus
Cardiovascular:
increased blood pressure
increase in heart rate
Pain:
headache
muscle cramps
pains in joints
Skin:
skin rash
bruises
Anxiety and behavioural changes:
sweating, trembling, feeling nervous or anxious
sleep disturbances
unusual activity and irritability (mainly in children)
Other:
slowing of growth in children and adolescents
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Allergic Reaction:
wheezing or difficulty breathing
swelling of the face, eyelids, lips/mouth, tongue or throat
chest pain or tightness
hay fever or lumpy rash ("hives")
fainting
Respiratory:
pneumonia (lung infection)
shortness of breath
Cardiovascular:
irregular heartbeat
Ocular:
eye problems (e.g. cataract, glaucoma)
Other:
rounded face
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Some side effects, for example changes in blood sugar (glucose) level, blood pressure
or loss of bone density can only be found when your doctor does tests from time to
time to check your progress.
Taking high doses of steroids for a long time could affect the adrenal glands, which
make the body's own steroid. Your doctor may do tests to check how the adrenal glands
are working.
Your doctor will be able to answer any questions you may have.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What PAVTIDE ACCUHALER contains
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Active ingredient
(main ingredient)
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fluticasone propionate
salmeterol xinafoate
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Other ingredients
(inactive ingredients)
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lactose monohydrate (which contains milk protein)
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Do not take this medicine if you are allergic to any of these ingredients.
What the PAVTIDE ACCUHALER looks like
PAVTIDE ACCUHALER is a moulded plastic inhaler device containing a foil strip with
28 or 60 blisters.
Each blister contains 100 or 250 or 500 micrograms of the active ingredient fluticasone
propionate. The amount depends on which strength of PAVTIDE ACCUHALER you have been
given.
Each blister also contains 50 micrograms of the active ingredient salmeterol.
Each different strength of PAVTIDE ACCUHALER is represented by a different shade of
purple on the carton and ACCUHALER labels.
Each blister also contains lactose monohydrate as a carrier.
The blisters protect the powder for inhalation from the effects of the atmosphere.
The ACCUHALER device has a dose counter which tells you the number of doses remaining.
It counts down from 28 or 60 to 0. The numbers appear in red when the last five doses
have been reached.
Never use your ACCUHALER if the dose counter reads 0. When the counter shows 0 your
ACCUHALER is empty and should be disposed of.
Who distributes PAVTIDE ACCUHALER
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067
Australia.
PAVTIDE ACCUHALER
100/50 - AUST R 208202
250/50 - AUST R 208201
500/50 - AUST R 208200
This leaflet was prepared in October 2021.
Trade marks are owned by or licensed to the GSK group of companies
© 2021 GSK group of companies or its licensor
Version 5.0