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 being given FLOLAN?
FLOLAN contains the active ingredient epoprostenol sodium. FLOLAN is used to treat
some types of pulmonary arterial hypertension (PAH). PAH is characterised by high
blood pressure in the blood vessels between the heart and lungs.
For more information, see Section
1. Why am I being given FLOLAN? in the full CMI.
2. What should I know before I am given FLOLAN?
Do not use if you have ever had an allergic reaction to epoprostenol sodium or any
of the ingredients listed at the end of the CMI or if you have heart disease with
shortness of breath and swelling of the feet or legs due to fluid build-up.
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 FLOLAN and affect how it works.
4. How am I given FLOLAN?
FLOLAN is given as in intravenous infusion into a vein.
Before you are given FLOLAN it must be dissolved with the supplied diluent and filtered.
Your doctor or nurse will show you how to make up FLOLAN and how to administer it
if you are using FLOLAN at home.
5. What should I know while using FLOLAN?
|
Things you should do
|
Remind any doctor, nurse, dentist or pharmacist you visit that you are using FLOLAN
Tell your doctor if you have not used FLOLAN as intended
Call your doctor if you become pregnant, intend to become pregnant or are breastfeeding
|
|
Things you should not do
|
Do not stop using this medicine suddenly or change the dose without first checking
with your doctor
Do not use any other piece of equipment or material to administer FLOLAN besides what
your doctor or pharmacist have given you.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how FLOLAN
affects you
FLOLAN may cause dizziness, drowsiness or tiredness in some people
|
|
Looking after your medicine
|
Store FLOLAN below 25°C in the box to protect it from light.
Do not freeze.
Once FLOLAN has been mixed with the diluent it should be used immediately or stored
as per the conditions listed in section 5 of the full CMI.
|
6. Are there any side effects?
Side effects which have been reported include headache, jaw pain, pain, nausea and
vomiting, diarrhoea, stomach discomfort or pain, redness of the face (flushing), joint
pain, rash, pain or redness at the injection site, sweating, dry mouth, feeling tired
or weak, feeling anxious, nervous or agitated, palling of the skin.
If you experience an allergic reaction (symptoms include wheezing, difficulty in breathing,
swelling of the lips/mouth/tongue, hay fever, lumpy rash (“hives”) and fainting) go
to the Emergency Department of your nearest hospital immediately.
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 ingredient(s):
epoprostenol sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about using FLOLAN. 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 FLOLAN.
Where to find information in this leaflet:
1. Why am I being given FLOLAN?
FLOLAN contains the active ingredient epoprostenol sodium. FLOLAN belongs to a group of medicines called prostaglandins.
FLOLAN is used to treat some types of pulmonary arterial hypertension (PAH).
PAH is characterised by high blood pressure in the blood vessel that carries blood
from the heart to the lungs and increased resistance in the blood vessels of the lung.
The cause of PAH is not known however there are a number of diseases such as scleroderma
that are associated with PAH.
FLOLAN works by widening the blood vessels in the lungs which lowers the blood pressure
in your lungs (known as vasodilator action).
2. What should I know before I am given FLOLAN?
Warnings
Do not use FLOLAN if:
you are allergic to epoprostenol sodium, or any of the ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have heart disease with shortness of breath and swelling of the feet or legs due
to fluid build-up.
Check with your doctor if you:
have any other medical conditions
have heart disease
take any medicines for any other condition
take any medicine to prevent blood clots such as heparin, warfarin, aspirin or other
non-steroidal anti-inflammatory drugs (NSAIDs)
take any medicines to treat high blood pressure
take medicines known as nitrates that are used to treat angina
take digoxin which is used to treat heart failure
are on a sodium controlled diet
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.
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 FLOLAN and affect how it works.
medicines used to prevent blood clots such as heparin, warfarin, aspirin or other
non-steroidal anti-inflammatory drugs (NSAIDs)
medicines to treat high blood pressure
nitrates, medicines used to treat angina
digoxin, a medicine used to treat heart failure
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FLOLAN.
4. How am I given FLOLAN?
How is FLOLAN given
FLOLAN is given as an intravenous infusion, normally through a permanently fitted
intravenous catheter (during initial treatment a peripheral line may be used which
is a non-permanent catheter) through a pump.
There are only certain pumps which can be used. Your doctor will make sure you are
using the right one.
Your doctor or nurse will show you how to keep your catheter clean and the area around
it clean and free from infection. They will show you how to prepare and administer
FLOLAN and how to stop treatment if necessary. It is very important to follow these
instructions carefully.
Before FLOLAN is given it must be dissolved only in the specific diluent supplied
with the medicine and then filtered.
The diluent does not contain any preservative. Use the vial once and then discard
it.
Tell your doctor or nurse if your catheter becomes blocked during the infusion.
How much is given
Initial treatment with FLOLAN will start in hospital.
your doctor will start you on an infusion and slowly increase the dose (every 15 mins)
to find the most effective or largest dose you can tolerate (you will also learn how
your body tolerates FLOLAN).
Infusions will then continue based on the dose you can tolerate.
The infusion rate may be increased or decreased depending on your response to treatment.
All changes should be done gradually and under the direction of your doctor.
If you develop pulmonary oedema (water on the lungs) during this time your doctor
may decide to stop treating you with FLOLAN.
How long to take FLOLAN
Use FLOLAN for as long as your doctor tells you to.
FLOLAN is generally used over a long period of time, possibly years.
Do not stop using FLOLAN suddenly. If you do, you might experience dizziness, weakness
and difficulty breathing.
If you forget to use FLOLAN
FLOLAN should be used regularly at the time that your doctor tells you.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much FLOLAN
If you think that you may have been given too much FLOLAN, you may need urgent medical
attention.
As FLOLAN has vasodilatory action, using too much may lead to low blood pressure,
loss of consciousness, nausea, diarrhoea, vomiting, facial flushing, headache and
a fast heartbeat.
If you are being given FLOLAN in hospital, the effects of FLOLAN are monitored carefully
by your doctor. In the unlikely event that you receive too much, appropriate action,
such as reducing the dose can be taken promptly.
If you are using FLOLAN at home and you think you have used too much 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.
5. What should I know while using FLOLAN?
Things you should do
tell your doctor if you have not used FLOLAN as it was prescribed for you, otherwise
they may change your treatment unnecessarily
Call your doctor straight away if you:
become pregnant, intend to become pregnant
are breastfeeding or intend to start breastfeeding
Remind any doctor, nurse, dentist or pharmacist you visit that you are using FLOLAN.
Things you should not do
do not stop using this medicine suddenly or change the dosage without first checking
with your doctor.
do not give this medicine to anyone else, even if their symptoms seem similar to yours.
do not use this medicine to treat any other complaints unless your doctor tells you
to.
do not use any other piece of equipment or material to administer FLOLAN besides what
your doctor or pharmacist have given you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FLOLAN
affects you.
FLOLAN may cause dizziness, drowsiness or tiredness in some people.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Keep the medicine in the box until it is time to use it to protect it from light.
Store FLOLAN and the diluent in in a cool dry place (below 25°C) 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
in the freezer
Keep it where young children cannot reach it.
Once FLOLAN has been prepared with the diluent
Administer the medicine immediately
When to discard your medicine
If you do not administer FLOLAN straight away you can store it under the following
conditions:
up to 48 hours if stored at temperatures up to 25°C
up to 36 hours if stored at temperatures up to 30°C
up to 24 hours if stored at temperatures up to 35°C
up to 12 hours if stored at temperatures up to 40°C
up to 8 days if kept between 2°C and 8°C
Any unused solution should be discarded after the above times have passed.
Never freeze FLOLAN.
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.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
headache
jaw pain
pain
nausea and vomiting
diarrhoea
stomach discomfort or pain
redness of the face (flushing)
joint pain
rash
pain or redness at the injection site
sweating
dry mouth
feeling tired, weak
feeling anxious, nervous or agitated
palling of the skin
low blood pressure
heart beating faster
slow heart beat
|
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, symptoms include wheezing, difficulty in breathing, swelling of
the lips/mouth/tongue, hay fever, lumpy rash (“hives”) and fainting
too much blood being pumped from the heart which may lead to persistent cough, shortness
of breath, fatigue, swelling of the legs and abdomen due to fluid build-up (high output
cardiac failure)
bleeding at various sites and bruising more easily than normal, for example from the
nose or gums
infection of the blood (septicaemia)
chest pain, feeling of tightness around the chest
a build-up of fluid in the lung (pulmonary oedema) which may lead to breathlessness,
which may be very severe and usually worsens upon lying down
swelling due to the build-up of fluid around the stomach
infection at the injection site
enlarged or overactive spleen which may cause pain or a feeling of fullness in the
left upper abdomen that may spread to the left shoulder, feeling full without eating
or after eating only a small amount, fatigue, frequent infections and/or easily bleeding
symptoms of an overactive thyroid gland which may lead to sudden weight loss, a rapid
heartbeat, increased sensitivity to heat, difficulty sleeping, fatigue and/or brittle
hair
|
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.
|
If you have a blood test it might show a decrease in the number of platelets (cells
that help the blood clot). This may lead to bleeding or bruising more easily than
normal.
FLOLAN may affect your blood sugar levels, heart rate and blood pressure during the
infusion. Your doctor will monitor these.
It is important to keep the area around the catheter clean. If the skin around the
catheter becomes infected it can potentially spread into your blood (known as septicaemia).
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 FLOLAN contains
|
Active ingredient
(main ingredient)
|
epoprostenol sodium
|
|
Other ingredients
(inactive ingredients)
|
glycine
mannitol
sodium chloride
sodium hydroxide
water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What FLOLAN looks like
FLOLAN is a sterile white to off white powder supplied with a diluent in the following
presentations:
0.5 mg vial with either 1 or 2 vials of diluent and 1 filter (AUST R 80342)
1.5 mg vial with either 1 or 2 vials of diluent and 1 filter (AUST R 80343)
Who distributes FLOLAN
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067
Phone: 1800 033 109
Trade marks are owned by or licensed to the GSK group of companies.
© 2023 GSK group of companies or its licensor.
This leaflet was prepared in September 2023.
Version 10.0