Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about bosentan. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine 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 this medicine is used for
Bosentan is used to treat high blood pressure in the blood vessels between the heart
and the lungs. This condition is called pulmonary arterial hypertension.
Bosentan belongs to a group of medicines called endothelin antagonists.
How it works
Bosentan acts to reduce abnormally high blood pressure by widening the blood vessels
between the heart and lungs.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
There is limited experience with the use of this medicine in children.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
any of the 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, throat or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you are pregnant or intend to become pregnant. You must
stop taking this medicine at least 3 months before trying to become pregnant.
Bosentan is known to cause harm to a developing baby if you take it in the three months
before becoming pregnant and during pregnancy.
Do not take this medicine if you have a moderate to severe liver disorder.
Do not take this medicine if you are taking ciclosporin A (a medicine used after a
transplant or to treat psoriasis) or glibenclamide (a medicine used for diabetes).
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
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
Bosentan may harm sperm. All men should use effective birth control while taking this
medicine and for 3 months after they stop taking it.
Sexually active women must use both hormonal and barrier methods of contraception.
Bosentan may reduce the effectiveness of hormonal contraceptives, such as the pill,
hormone patches, implants or injections. It is important to use other contraceptives,
like condoms or an intrauterine device (IUD). Your doctor will advise you about using
reliable contraceptives before taking this medicine.
You must have a negative pregnancy test at the time of starting treatment, and have
a pregnancy test every month while you are taking this medicine if you are sexually
Your doctor will need evidence that you are not pregnant before prescribing bosentan.
Tell your doctor if you are a woman of childbearing potential and not using reliable
You must have a negative pregnancy test before beginning treatment. The test should
be performed on the second day of a normal menstrual period or 11 days after the last
unprotected sexual intercourse, whichever is later. Your doctor will advise you about
using reliable contraception before taking or whilst taking this medicine.
Hormonal contraception on its own is not a reliable option because this medicine may
make this method ineffective in preventing pregnancy. Hormonal contraceptives include
ones you take orally (the pill), patches you put on your skin, ones that are injected
and implants. You should ALWAYS use additional methods of contraception, such as condoms
and IUDs, and not rely only on hormonal contraception. You should have a pregnancy
test every month while you are taking this medicine. You must stop taking this medicine
for at least 3 months prior to becoming pregnant.
Tell your doctor if you are breastfeeding.
It is not known whether bosentan passes into breast milk. Do not take this medicine
until you and your doctor have discussed the risks and benefits involved.
Tell your doctor if you have or have had any of the following medical conditions:
liver or kidney disorders
pulmonary veno-occlusive disease (PVOD)
pulmonary arterial hypertension with heart failure
coronary heart disease (CHD)
Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.
If you have not told your doctor about any of the above, tell them before you start
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
Some medicines must not be taken with bosentan. These include:
ciclosporin A, used to prevent organ transplantation rejection
glibenclamide, used to treat diabetes.
Some medicines may also interfere with bosentan. These include:
hormonal contraceptives (oral, injectable, transdermal and implantable)
simvastatin, used for lowering blood fats
medicines for bacterial infections (e.g. rifampicin)
medicines to prevent organ transplantation rejection (e.g. tacrolimus, sirolimus)
lopinavir and ritonavir or other ritonavir-boosted protease inhibitors, used to treat
digoxin, used to treat heart rhythm disorders
sildenafil, used to treat erectile dysfunction or pulmonary hypotension
warfarin, used to prevent blood clots
medicines used for fungal infections (e.g. ketoconazole, fluconazole and voriconazole)
nimodipine, a type of medication used to treat narrow blood vessels in the brain.
These medicines may be affected by this medicine or may affect how well it works.
You may need different amounts of your medicines, or you may need to take different
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Other medicines not listed above may also interact with bosentan.
How to take this medicine
Follow all directions given to you by your doctor carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines.
The usual starting dose is one 62.5 mg tablet taken twice daily.
Depending on how you respond to the medicine, your doctor may increase the dosage
after four weeks to one 125mg tablet twice daily.
Talk to your doctor if you do not think the medicine is working or you think it is
working too well. Your doctor may need to change the dose you are taking.
How to take it
Swallow the tablet whole with a full glass of water.
When to take it
Take one tablet in the morning and one tablet in the evening, at about the same time
Taking it at the same time each day will have the best effect and 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 for
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.
Make sure you have enough medicine to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you experiencing side effects.
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 to help you remember.
If you take too much (overdose)
Immediately telephone your doctor or the 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 taken too much of this medicine.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking this medicine
Things you must do
It is very important that you have a liver function blood test before you start treatment
and every month after that.
Bosentan can cause liver damage if it is not found early. As this side effect may
not cause symptoms at first, only a blood test can show that you have early liver
damage. Regular blood tests let your doctor change or stop your therapy before there
is permanent damage.
You should have a blood test for anaemia after 1 and 3 months and then every 3 months
for the rest of your treatment.
If you become pregnant while taking bosentan, tell your doctor immediately.
You need to have pregnancy tests monthly if you are a female of childbearing age.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking this medicine.
If you are about to have any blood tests, tell the doctor that you are taking this
If you are going to have surgery, tell the surgeon and anaesthetist that you are taking
It may affect other medicines used during surgery.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
Do not become pregnant whilst taking this medicine.
You must have a pregnancy test every month while you are taking this medicine. You
doctor will need evidence that you are not pregnant before prescribing the medicine
Do not give this medicine to anyone else, even if they have the same condition as
Do not take your medicine to treat any other complaints unless your doctor tells you
Do not stop taking your medicine or change your dosage without first checking with
Stopping your treatment may lead to worsening of your symptoms. Your doctor may tell
you to reduce the dose over a few days before stopping completely.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
This medicine may cause tiredness in some people. If you have any of these symptoms,
do not drive, operate machinery or do anything else that could be dangerous.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking bosentan.
Bosentan helps most people with pulmonary hypertension but 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
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following:
inflamed throat and irritated nasal passages
flushing (hot flushes)
ankle and leg swelling
low blood pressure
fast heart beat
dizziness, feeling faint
itching, rash, skin inflammation, skin redness
The above list includes some side effects that may require medical attention.
If any of the following happen, stop taking your medicine and contact your doctor
immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin (symptoms of an allergic reaction)
shortness of breath, wheezing or difficulty in breathing.
nausea or vomiting
yellowing of your skin or the whites of your eyes (jaundice).
The above list includes very serious side effects and you may need urgent medical
attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything else that is making you feel
Other side effects not listed above may occur in some patients.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its bottle it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 30°C.
Do not store your medicine, 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.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
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.
What it looks like
62.5 mg film coated tablets are light peach to peach coloured, round shaped, biconvex
and debossed with '62.5' on one side and plain on the other side.
125 mg film coated tablets are light peach to peach coloured, oval shaped, biconvex
and debossed with '125' on one side and plain on the other side.
Each tablet contains 62.5 mg or 125 mg bosentan (as monohydrate) as the active ingredient.
It also contains the following inactive ingredients:
pregelatinised maize starch
sodium starch glycollate type A
Film coating is OPADRY complete film coating system 21K520019 Yellow, which contains:
iron oxide yellow
iron oxide red
This medicine does not contain gluten, lactose, sucrose, tartrazine and other azo
Australian Registration Numbers
Bosentan APO 62.5 mg (bottle of 60 tablets) AUST R 257754.
Bosentan APO 125 mg (bottle of 60 tablets) AUST R 257734.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was prepared in