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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I taking BOSENTAN VIATRIS?
BOSENTAN VIATRIS contains the active ingredient bosentan. BOSENTAN VIATRIS is used
to treat pulmonary arterial hypertension.
2. What should I know before I take BOSENTAN VIATRIS?
Do not use if you have ever had an allergic reaction to bosentan 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 BOSENTAN VIATRIS and affect how it works.
4. How do I take BOSENTAN VIATRIS?
The usual dose is one tablet, twice daily. For the first 4 weeks you will take a 62.5
mg tablet twice daily. Your doctor may change the dose depending on how you respond.
5. What should I know while taking BOSENTAN VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using BOSENTAN VIATRIS.
Keep all your doctor’s appointments so your progress can be checked and monitored
for side effects.
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Things you should not do
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Do not become pregnant while taking this medicine. If there is any delay in getting
period or any other reason to suspect pregnancy, you must tell your doctor immediately
for pregnancy testing.
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Driving or using machines
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If you feel dizzy, tired or have blurred vision whilst taking this medicine do not
drive or operate any tools or machinery.
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Looking after your medicine
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Store below 25°C. Protect from moisture.
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6. Are there any side effects?
Common side effects include headache, respiratory tract infection, swelling of ankle,
leg and joint or other signs of fluid retention, low blood pressure and anaemia. Serious
side effects include shortness of breath, anaphylaxis and/ or swelling, nausea, vomiting,
fever, unusual tiredness, stomach pain, jaundice, dark-coloured urine and chest pain.
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WARNING: BOSENTAN VIATRIS causes birth defects and must not be used in pregnancy.
Rare cases of liver cirrhosis and liver failure have been reported in patients taking
BOSENTAN VIATRIS.
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Active ingredient(s):
bosentan (as monohydrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking BOSENTAN VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking BOSENTAN VIATRIS.
Where to find information in this leaflet:
1. Why am I taking BOSENTAN VIATRIS?
BOSENTAN VIATRIS contains the active ingredient bosentan. BOSENTAN VIATRIS belongs to the class of medicines known as endothelin receptor antagonists.
This medicine acts to reduce abnormally high blood pressure by widening these blood
vessels.
BOSENTAN VIATRIS is used for the treatment of high blood pressure in the blood vessels
between the heart and the lungs. This condition is called pulmonary arterial hypertension.
2. What should I know before I take BOSENTAN VIATRIS?
Warnings
Do not take BOSENTAN VIATRIS if:
you are allergic to bosentan, 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 are pregnant, think you may be pregnant or intend to become pregnant. You must
have a negative pregnancy test at the time of starting treatment if you are sexually
active. See additional information under
Pregnancy and breastfeeding.
you are being treated with ciclosporin A (a medicine used after a transplant or to
treat psoriasis).
you are being treated with glibenclamide (a medicine used for diabetes).
you have moderate to severe liver disorder.
Check with your doctor if you:
are a woman of childbearing potential and not using reliable contraceptive methods.
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. See additional information under
Pregnancy and breastfeeding.
use hormonal contraceptives including 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 just on hormonal contraception.
See additional information under
Pregnancy and breastfeeding.
have any other medical conditions, including:
anaemia (low levels of red blood cells
pulmonary arterial hypertension or lung disease/condition
hypotension (low blood pressure)
liver or kidney problems
heart disease or heart problems
HIV infection
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
Do not become pregnant while taking this medicine. BOSENTAN VIATRIS may harm unborn babies.
Your doctor will need evidence that you are not pregnant.
You must have a negative pregnancy test at the time of starting treatment if you are
sexually active.
You must have a pregnancy test every month while you are taking this medicine.
If there is any delay in getting period or any other reason to suspect pregnancy,
you must tell your doctor immediately for pregnancy testing.
Your doctor will need evidence that you are not pregnant before prescribing this medicine
again.
If you are sexually active, you must use a hormonal and barrier method of contraception.
BOSENTAN VIATRIS may reduce the effectiveness of hormone contraceptives such as the
pill and hormone patches, implants or injection. It is important to use other contraceptives,
like condoms or an intrauterine device.
Your doctor will advise you about using reliable contraceptives before taking this
medicine.
You must stop taking BOSENTAN VIATRIS at least 3 months before trying to become pregnant.
It is known that this medicine causes harm to the developing baby if you take it during
pregnancy and in the three months before becoming pregnant.
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.
You are advised to stop breastfeeding if this medicine is prescribed for you because
it has been reported that this drug passes into the milk in a woman who was taking
this medicine.
Do not father a child while taking BOSENTAN VIATRIS and for 3 months after stopping
treatment.
BOSENTAN VIATRIS may harm sperm. Use condoms and do not donate sperm during treatment
and for 3 months after your treatment has finished. Talk with your healthcare providers
if you have questions about birth control. If you plan to father a child, talk to
your doctor or healthcare professional before taking BOSENTAN VIATRIS.
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 BOSENTAN VIATRIS and affect how it works. These
include:
hormonal contraceptives (oral, injectable, transdermal and implantable)
simvastatin, medicines for lowering blood fats
medicines for diabetes such as glibenclamide and tolbutamide
medicines for fungal infections such as ketoconazole, itraconazole, fluconazole and
voriconazole
medicines for bacterial infections such as rifampicin
medicine to prevent organ transplantation rejection such as cyclosporine A, tacrolimus
and sirolimus
medicines for rheumatoid arthritis or psoriasis / dermatitis
lopinavir + ritonavir or other ritonavir-boosted protease inhibitors and nevirapine
(used to treat HIV)
warfarin (used as anti-clotting medicines)
digoxin (used to treat heart rhythm disorders)
sildenafil or tadalafil (used to treat erectile dysfunction and/or pulmonary arterial
hypertension)
phenytoin, carbamazepine or phenobarbital (medicines for seizures)
nimodipine
St John's Wort (a herbal medicine used for depression)
These medicines may be affected by BOSENTAN VIATRIS or may affect how well it works.
You may need to use different amounts of your medicines or 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 BOSENTAN VIATRIS.
4. How do I take BOSENTAN VIATRIS?
How much to take
Adults
The usual dose is one tablet, twice daily. For the first 4 weeks you will take a 62.5
mg tablet twice daily.
Depending on how you respond to the medicine, your doctor may increase the dosage
after four weeks to a 125 mg tablet twice daily.
Patients with low body weight
If you have body weight less than 40 kg but are over 12 years old, your doctor may
advise you to take a 62.5 mg tablet twice daily. The usual dose is one tablet, twice
daily.
Children aged 3 years and over
The dose will be determined by your doctor depending on the weight of the child.
Always take this medicine exactly as your doctor has instructed you. You should check
with your doctor or pharmacist if you are unsure.
When to take BOSENTAN VIATRIS
BOSENTAN VIATRIS is taken by mouth, in the morning and evening, and can be taken with
or without food.
Do not stop taking this medicine suddenly unless your doctor tells you to.
Stopping your treatment may lead to a worsening of your symptoms. Your doctor may
tell you to reduce the dose over a few days before stopping completely.
If you forget to take BOSENTAN VIATRIS
BOSENTAN VIATRIS should be used regularly at the same time each day. If you miss your
dose at the usual time, if there is still a long time to go before your next dose,
take it as soon as you remember and then go back to taking it as you would normally.
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 take too much BOSENTAN VIATRIS
If you think that you have used too much BOSENTAN VIATRIS, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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 taking BOSENTAN VIATRIS?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using BOSENTAN VIATRIS.
Be sure to keep all your doctor’s appointments so your progress can be checked and
to monitor for side effects.
It is very important that you have a liver function blood test before you start treatment
and every month after that.
BOSENTAN VIATRIS can cause liver damage if it is not found early. Because 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.
You need to have pregnancy tests before you start treatment and monthly if you are
a female of childbearing age.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BOSENTAN
VIATRIS affects you.
BOSENTAN VIATRIS may cause dizziness, tiredness or blurred vision in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
We have no information on how alcohol affects BOSENTAN VIATRIS.
Looking after your medicine
Store below 25°C. Protect from Moisture.
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 young 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.
Less serious side effects
Serious side effects
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 BOSENTAN VIATRIS contains
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Active ingredient
(main ingredient)
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bosentan (as monohydrate)
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Other ingredients
(inactive ingredients)
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Maize starch
Pregelatinised maize starch
Sodium starch glycollate
Povidone
Glyceryl behenate
Magnesium stearate
Sodium lauryl sulfate
OPADRY complete film coating system 03K580000 WHITE (ID: 108721)
SURELEASE aqueous ethylcellulose dispersion E-7-19040 clear (ID: 11522)
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Potential allergens
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contains trace quantities of sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What BOSENTAN VIATRIS looks like
BOSENTAN VIATRIS 125 mg tablets are white to off-white, film coated, oval, biconvex,
beveled edge tablet debossed with "M" on one side of the tablet and "BN2" on the other
side. (AUST R 206776).
Who distributes BOSENTAN VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2025.
BOSENTAN VIATRIS_cmi\Jul25/00