What is in this leaflet

Please read this leaflet carefully before you start using Pavtide.
This leaflet answers some common questions about Pavtide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Pavtide against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What Pavtide is used for

Pavtide is available as a dry powder device called an Accuhaler.
Pavtide Accuhaler: 100/50, 250/50,500/50
Pavtide 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).
Pavtide contains two medicines, 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.
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.
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.

Before you use Pavtide

When you must not take it

Do not take Pavtide if you have an allergy to:
any medicine containing fluticasone propionate
any medicine containing salmeterol xinafoate
lactose or milk proteins (this applies to the Accuhaler only)
any of the ingredients listed at the end of this leaflet
Some of the 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 ("hives")
fainting
Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
If you use it after the expiry date has passed, it may not work as well.
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:
thrush in your mouth
tuberculosis (TB)
diabetes
a thyroid condition
high blood pressure or a heart problem
low blood potassium levels
Tell your doctor if you are taking other steroid medicines by mouth or inhalation.
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.
If you have not told your doctor about any of the above, tell him/her before you start taking Pavtide.

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 Pavtide may interfere with each other. 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 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.
If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.

How to take Pavtide

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 mcg fluticasone propionate and 50 mcg salmeterol), or
Pavtide Accuhaler 250/50 (250 mcg fluticasone propionate and 50 mcg salmeterol), or
Pavtide Accuhaler 500/50 (500 mcg fluticasone propionate and 50 mcg 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 mcg fluticasone propionate and 50 mcg 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 mcg fluticasone propionate and 50 mcg salmeterol), or
Pavtide Accuhaler 500/50 (500 mcg fluticasone propionate and 50 mcg salmeterol)
The usual dose is one puff from your Accuhaler twice a day.

How to take it

The medicine in Pavtide should be inhaled into your lungs.
Pavtide must only be breathed in through the mouth.
The full instructions for using Pavtide are given on a leaflet inside the pack.
If you have any difficulties using Pavtide 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.

When to take it

Your doctor has chosen this medicine to suit you and your condition. Pavtide is used to help with asthma and COPD in people who need regular treatment.
It is very important that you use your Pavtide 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 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.

How long to take it

Continue taking your medicine for as long as your doctor tells you to.
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 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 take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (in Australia telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Pavtide.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers for these places handy.
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.

While you are using Pavtide

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Pavtide.
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.
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.

Things you must not do

Do not take Pavtide 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.

Things to be careful of

Be careful driving or operating machinery until you know how Pavtide affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Pavtide, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
If your breathing or wheezing gets worse straight after using your Accuhaler, stop using it immediately and tell your doctor as soon as possible.
This medicine helps most people with asthma and COPD. Most people using this medicine find that it causes no problem, but it may have unwanted side effects in a few people. All medicines 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 lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Common Side Effects
soreness in the mouth, throat or tongue
hoarseness
headache
muscle cramps
pains in joints
increase in heart rate
Pneumonia (lung infection) has been reported commonly in patients with COPD.
Uncommon Side Effects
skin rash
shortness of breath
sweating, trembling, feeling nervous or anxious
bruising
Eye problems (e.g. cataract, glaucoma)
sleep disturbances
Rare Side Effects
swelling of the face, lips, mouth, tongue or throat
irregular heartbeat
behavioural changes, including unusual activity and irritability (mainly in children).
Rounded face
Slowing of growth in children and adolescents
Soreness in the oesophagus
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 Accident and Emergency at your nearest hospital, as you may be having an 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
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
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.
If you have any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

After using Pavtide

Rinse mouth after use

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. Tell your doctor but do not stop treatment unless told to do so.

Storage

Keep your Pavtide in a dry place where the temperature stays below 30°C, away from direct heat or sunlight.
Do not store Pavtide 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.
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

Accuhaler

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 you have been given.
Each blister also contains 50 micrograms of the active ingredient salmeterol.
Each different strength of Pavtide 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.

Ingredients

Pavtide contains the active ingredients:
fluticasone propionate
salmeterol xinafoate
Your Pavtide Accuhaler also contains lactose monohydrate (which contains milk protein)

Supplier

Pavtide is supplied in Australia by:
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067
Australia
Pavtide Accuhaler
500/50-AUST R 208202
250/50-AUST R 208201
100/50-AUST R 208200
This leaflet was prepared on 26 March 2020.
Trade marks are owned by or licensed to the GSK group of companies
© 2020 GSK group of companies or its licensor
Version 3.0