PAVTIDE ACCUHALER
  • Download PDF Standard Print
  • Download PDF Large Print
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.

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.
For more information, see Section 1. Why am I using PAVTIDE ACCUHALER? in the full CMI.

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.
For more information, see Section 2. What should I know before I use PAVTIDE ACCUHALER? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with PAVTIDE ACCUHALER 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.

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.
More instructions can be found in Section 4. How do I use PAVTIDE ACCUHALER? in the full CMI.

What should I know while using PAVTIDE ACCUHALER?

Things you should do
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.
Things you should not do
Do not stop using this medicine suddenly or change the dosage without checking with your doctor.
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 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.
For more information, see Section 5. What should I know while using PAVTIDE ACCUHALER? in the full CMI.

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.
PAVTIDE ACCUHALER
  • Download PDF Standard Print
  • Download PDF Large Print
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:

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

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.

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.

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.

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.

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

Less serious side effects
What to do
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
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
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
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.
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.

Product details

This medicine is only available with a doctor's prescription.

What PAVTIDE ACCUHALER contains

Active ingredient
(main ingredient)
fluticasone propionate
salmeterol xinafoate
Other ingredients
(inactive ingredients)
lactose monohydrate (which contains milk protein)
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

  • Download PDF Standard Print
  • Download PDF Large Print