Bosentan 62.5 mg/125 mg film-coated tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about BOSENTAN SANDOZ.
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 using
this medicine against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What BOSENTAN SANDOZ is used for
BOSENTAN SANDOZ 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.
This medicine acts to reduce abnormally high blood pressure by widening these blood
vessels. It belongs to the class of medicines known as endothelin receptor antagonists.
Your doctor however, may prescribe BOSENTAN SANDOZ for another purpose.
Ask your doctor if you have any questions why it has been prescribed for you.
This medicine is only available with a doctor’s prescription.
Before you take BOSENTAN SANDOZ
When you must not take BOSENTAN SANDOZ
Do not take this medicine if you are:
Pregnant or intend to become pregnant. You must stop taking the medicine 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.
Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding
if this medicine is prescribed for you because it is not known if this drug passes
into the milk in women who are taking this medicine.
Being treated with cyclosporine A
(a medicine used after a transplant or to treat psoriasis)
Being treated with glibenclamide
(a medicine used for diabetes)
Do not take BOSENTAN SANDOZ if you are allergic to it or any of the ingredients listed
at the end of this leaflet.
Do not take BOSENTAN SANDOZ if you have moderate to severe liver disorder
Do not take it after the expiry date (EXP) printed on the carton and blister pack.
If you take it after the expiry date has passed, it may not work as well.
Do not take it if the packaging is torn or shows signs of tampering.
Before you start to take BOSENTAN SANDOZ
BOSENTAN SANDOZ may harm sperm. All men should use effective birth control while taking
this medicine and for 3 months after they stop taking it.
If sexually active, you must use a hormonal and barrier method of contraception.
This medicine 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
You must have a negative pregnancy test at the time of starting treatment if you are
Your doctor will need evidence that you are not pregnant.
Tell your doctor if:
1. 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. 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 just 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.
2. you are breastfeeding or planning to breastfeed.
It is not known whether BOSENTAN SANDOZ passes into breast milk.
3. You have allergies to:
any other medicines
any other substances such as foods, preservatives or dyes.
4. You have or have had any medical conditions, especially the following:
pulmonary arterial hypertension
liver or renal disorders
If you have not told your doctor about any of the above, tell them before you use
While taking BOSENTAN SANDOZ
Do not become pregnant while taking this medicine.
You must have a pregnancy test every month while you are taking this medicine.
Your doctor will need evidence that you are not pregnant before prescribing this medicine
Interactions with other medicines
Tell your doctor if you are taking any other medicines including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with BOSENTAN SANDOZ. These include:
hormonal contraceptives (oral, injectable, transdermal and implantable)
simvastatin, medicines for lowering blood fats
medicines for diabetes such as glibenclamide
medicines for fungal infections such as ketaconazole, fluconazole and voriconazole
medicines for bacterial infections such as rifampicin
medicine to prevent organ transplantation rejection such as Cyclosporine A and tacrolimus
medicines for rheumatoid arthritis or psoriasis/dermatitis
lopinavir+ritonavir or other ritonavir-boosted protease inhibitors (used to treat
digoxin (used to treat heart rhythm disorders)
sildenafil (used to erectile dysfunction and/or also pulmonary hypertension
These medicines may be affected by BOSENTAN SANDOZ or may affect how well it works.
You may need to use different amounts of your medicines, or take different medicines.
Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking BOSENTAN SANDOZ.
How to take BOSENTAN SANDOZ
How much to take
Always take this medicine exactly as your doctor has instructed you.
You should check with your doctor or pharmacist if you are unsure.
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. If you do not
think the medicine is working or you think it is working too well, talk to your doctor.
Your doctor may need to change the dose you are taking.
How to take this medicine
BOSENTAN SANDOZ is taken by mouth, in the morning and evening, and can be taken with
or without food.
How long to take it
Do not stop taking this medicine 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 it
If it is almost time for your next dose, skip the dose you missed and take the next
dose when you are meant to.
Do not take a double dose to make up for the dose you have missed.
This may increase the chance of getting an unwanted side effect.
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 you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) or go to Accident and Emergency at your nearest hospital if you think you or
anyone else may have taken too much BOSENTAN SANDOZ.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using BOSENTAN SANDOZ
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 SANDOZ 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 monthly if you are a female of childbearing age
Things you must not do
Do not give the tablets to anyone else even if they have the same symptoms as you.
Things to be careful of
If you feel dizzy whilst taking this medicine, do not drive or operate any tools or
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
shortness of breath or difficulty in breathing
yellowing of your skin or the whites of your eyes (jaundice)
These may be serious side effects of BOSENTAN SANDOZ. You may need urgent medical
Serious side effects are uncommon.
Other side effects of this medicine include:
Inflamed throat and irritated nose passages
Flushing (hot flashes)
Ankle and leg swelling
Low blood pressure
Fast heart beat
Itching, rash, skin inflammation, skin redness
See your doctor if any of these worry you.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some consumers.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using BOSENTAN SANDOZ
Store this medicine in the original container at or below 25°C.
Keep out of reach of children.
What it looks like
BOSENTAN SANDOZ 62.5 mg tablets are
BOSENTAN SANDOZ 125 mg tablets are.
Cartons of 60 tablets in blister packs.
BOSENTAN SANDOZ 62.5 mg: 62.5 mg bosentan per tablet.
BOSENTAN SANDOZ 125 mg: 125 mg bosentan per tablet.
maize starch, pregelatinized maize starch, sodium starch glycollate type A, povidone,
polaxamer, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate, purified
water, ethanol, hypromellose, titanium dioxide, ethylcellulose, triacetin, purified
talc, iron oxide yellow, iron oxide red and iron oxide black.
BOSENTAN SANDOZ is supplied in Australia by:
Sandoz Pty Ltd.
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park NSW
Tel: 1800 634 500
This leaflet was prepared on November 2016
Australian Register Number:
BOSENTAN SANDOZ 62.5 mg - AUST R 242052
BOSENTAN SANDOZ 125 mg - AUST R 242053