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BOSENTAN 62.5 MG FILM-COATED TABLETS

Active substance(s): BOSENTAN MONOHYDRATE / BOSENTAN MONOHYDRATE

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BOSENTAN
62.5 mg AND 125 mg
FILM-COATED TABLETS
Package leaflet: Information for the user

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:

1. What Bosentan is and what it is used
for
2. What you need to know before you
take Bosentan
3. How to take Bosentan
4. Possible side effects
5. How to store Bosentan
6. Contents of the pack and other
information

1 What Bosentan is and what it
is used for
Bosentan tablets contain bosentan, which
blocks a naturally occurring hormone
called endothelin-1 (ET-1), which causes
blood vessels to narrow. Bosentan
therefore causes blood vessels to expand
and belongs to the class of medicines
called “endothelin receptor antagonists”.
Bosentan is used to treat:
• Pulmonary arterial hypertension (PAH):
PAH is a disease of severe narrowing
of the blood vessels in the lungs
resulting in high blood pressure in the
blood vessels (the pulmonary arteries)
that carry blood from the heart to the
lungs. This pressure reduces the
amount of oxygen that can get into the
blood in the lungs, making physical
activity more difficult. Bosentan
widens the pulmonary arteries, making
it easier for the heart to pump blood
through them. This lowers the blood
pressure and relieves the symptoms.
Bosentan is used to treat patients with
class III pulmonary arterial hypertension
(PAH) to improve exercise capacity (the
ability to carry out physical activity) and
symptoms. The ‘class’ reflects the
seriousness of the disease: ‘class III’
involves marked limitation of physical
activity. Some improvements have also
been shown in patients with class II PAH.
‘Class II’ involves slight limitation of
physical activity. The PAH for which
Bosentan is indicated can be:
• primary (with no identified cause or
familial)
• caused by scleroderma (also called
systemic sclerosis, a disease where
there is abnormal growth of the
connective tissue that supports the
skin and other organs)
• caused by congenital (inborn) heart
defects with shunts (abnormal
passageways) causing abnormal flow
of blood through the heart and lungs.

write the date of your most recent test
and also of your next test (ask your
doctor for the date) on the Patient Alert
Card, to help you remember when your
next test is due.
Blood tests for liver function
These will be done every month for the
duration of treatment with Bosentan.
After an increase in dose an additional
test will be done after 2 weeks.
Blood tests for anaemia
These will be done every month for the
first 4 months of treatment, then every
3 months after that, as patients taking
Bosentan may get anaemia.
If these results are abnormal, your doctor
may decide to reduce your dose or stop
treatment with Bosentan and to perform
further tests to investigate the cause.
Children and adolescents
Bosentan is not recommended in
paediatric patients with systemic
sclerosis and ongoing digital ulcer
disease. Please see also section 3 “How
to take Bosentan”.
Other medicines and Bosentan
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription. It is
especially important to tell your doctor if
you are taking:
• cyclosporine A (a medicine used after
transplants and to treat psoriasis),
which must not be used together with
Bosentan
• sirolimus or tacrolimus, which are
medicines used after transplants, as
these are not recommended to be
used together with Bosentan
• glibenclamide (a diabetes medicine),
rifampicin (a tuberculosis medicine) or
fluconazole (a medicine against fungal
infections), nevirapine (an HIV
medicine) as these medicines are not
recommended to be used together
with Bosentan
• other medicines for the treatment of
HIV infection, which may require
special monitoring if used together
with Bosentan
• hormonal contraceptives, which are
not effective as the sole method of
contraception when you take
Bosentan. Inside your pack of
Bosentan tablets you will find a Patient
Alert Card which you should read
carefully. Your doctor and/or
gynaecologist will establish the
contraception which is appropriate for
you.
Women of child-bearing age
Do not take Bosentan if you are pregnant
or planning to become pregnant.
Pregnancy tests
Bosentan may harm unborn babies
conceived before starting or during
treatment. If you are a woman who could
become pregnant, your doctor will ask
you to take a pregnancy test before you
start taking Bosentan, and regularly while
you are taking Bosentan.

Contraceptives
If it is possible that you could become
pregnant, use a reliable form of birth
control (contraception) while you are
taking Bosentan. Your doctor or
gynaecologist will advise you about
• Digital ulcers: (sores on the fingers
reliable contraceptive methods while
and toes) in adult patients with a
taking Bosentan. Because Bosentan may
condition called scleroderma.
make hormonal contraception (e.g., oral,
Bosentan reduces the number of new injection, implant, or skin patches)
finger and toe ulcers that appear.
ineffective, this method on its own is not
reliable. Therefore, if you use hormonal
2 What you need to know before contraceptives you must also use a
you take Bosentan
barrier method (e.g., female condom,
diaphragm, contraceptive sponge, or
Do not take Bosentan if you:
your partner must also use a condom).
• are allergic to bosentan or any of the
Inside your pack of Bosentan tablets you
other ingredients of this medicine
will find a Patient Alert Card. You should
(listed in section 6)
complete this card and take it to your
• have liver problems (ask your doctor) doctor at your next visit so that your
• are pregnant, or could get pregnant
doctor or gynaecologist can assess
because you are not using reliable
whether you need additional or
contraceptive methods. Please read
alternative reliable contraceptive
the information under
methods. Monthly pregnancy tests are
“Contraceptives” and “Other
recommended while you are taking
medicines and Bosentan”
Bosentan and are of child-bearing age.
• are taking cyclosporine A (a medicine
used after a transplant or to treat
Tell your doctor immediately if you
psoriasis).
become pregnant while you are taking
Bosentan, or plan to become pregnant in
If any of these apply to you, tell your
the near future.
doctor.
Breast-feeding
Warnings and precautions
Tell your doctor immediately if you are
Tests your doctor will do before
breast-feeding. You are advised to stop
treatment:
breast-feeding if Bosentan is prescribed
• a blood test to check your liver
for you, because it is not known whether
function
this medicine passes into breast milk.
• a blood test to check for anaemia (low
haemoglobin)
Fertility
• a pregnancy test if you are a woman of If you are a man taking Bosentan, it is
child-bearing potential.
possible that this medicine may lower
Some patients taking Bosentan have
your sperm count. It cannot be excluded
been found to have abnormal liver
that this may affect your ability to father a
function tests and anaemia (low
child. Talk to your doctor if you have any
haemoglobin).
questions or concerns about it.
Tests your doctor will do during
treatment
During treatment with Bosentan, your
doctor will arrange for regular blood tests
to check for changes in your liver function
and haemoglobin level.

Driving and using machines
Bosentan has no or negligible influence
on the ability to drive and use machines.
However, Bosentan can induce
hypotension (decrease of your blood
pressure) which can make you feel dizzy,
affect your vision and affect your ability
For all these tests please refer also to the to drive and use machines. Therefore, if
Patient Alert Card (inside your pack of
you feel dizzy or that your vision is
Bosentan tablets). It is important that you blurred while taking Bosentan, do not
have these regular blood tests as long as drive or operate any tools or machines.
you are taking Bosentan. We suggest you

3 How to take Bosentan

• neutropenia/leukopenia (low number
of white blood cells)
• elevated liver function tests with
Treatment with Bosentan should only be
hepatitis (inflammation of the liver)
started and monitored by a doctor who
including possible exacerbation of
has experience in the treatment of PAH or
underlying hepatitis and/or jaundice
systemic sclerosis. Always take this
(yellowing of the skin or the whites of
medicine exactly as your doctor has told
the eyes).
you. Check with your doctor or
pharmacist if you are not sure.
Rare: may affect up to one in 1000 people
• anaphylaxis (general allergic reaction),
Bosentan with food and drink
angioedema (swelling, most
Bosentan can be taken with or without
commonly around the eyes, lips,
food.
tongue or throat)

cirrhosis (scarring) of the liver, liver
Recommended dose
failure (serious disturbance of liver
function).
Adults
The treatment in adults is usually started
Not known: frequency cannot be
for the first 4 weeks with 62.5 mg twice
estimated from the available data
daily (morning and evening), from then
• blurred vision.
your doctor will usually advise you to
take a 125 mg tablet twice daily,
Side effects in children and adolescents
depending on how you react to Bosentan.
The side effects that have been reported
in children treated with Bosentan are the
Use in children and adolescents
The dose recommendation in children is same as those in adults.
only for PAH. For children 1 year and
Reporting of side effects
older, treatment with bosentan is usually
If you get any side effects, talk to your
started with 2 mg per kg bodyweight
doctor or pharmacist. This includes any
twice daily (morning and evening). Your
possible side effects not listed in this
doctor will advise you on your dosing.
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
Please note that bosentan is also
www.mhra.gov.uk/yellowcard
available as a dispersible 32 mg tablet
By reporting side effects you can help
formulation, which may make correct
provide more information on the safety of
dosing easier for children and patients
this medicine.
with low body weight or difficulties to
swallow film-coated tablets.
If you have the impression that the effect
of Bosentan is too strong or too weak,
talk to your doctor in order to find out
whether your dose needs to be changed.

5 How to store Bosentan

Keep this medicine out of the sight and
reach of children.

Do not use this medicine after the expiry
How to take Bosentan
date which is stated on the carton and
Tablets should be taken (morning and
blister after EXP. The expiry date refers to
evening), swallowed with water. The
the last day of that month.
tablets can be taken with or without food.
Store below 30°C.
If you take more Bosentan than you
should
Do not throw away any medicines via
If you take more tablets than you have
wastewater or household waste. Ask your
been told to take, contact your doctor
pharmacist how to throw away medicines
immediately.
you no longer use. These measures will
help protect the environment.
If you forget to take Bosentan
If you forget to take Bosentan, take a
6 Contents of the pack and other
dose as soon as you remember, then
information
continue to take your tablets at the usual
times. Do not take a double dose to make What Bosentan contains
up for forgotten tablets.
• The active substance is bosentan.
• Each 62.5 mg film-coated tablet
If you stop taking Bosentan
contains 62.5 mg bosentan (as
Suddenly stopping your treatment with
monohydrate).
Bosentan may lead to your symptoms
• Each 125 mg film-coated tablet
getting worse. Do not stop taking
contains 125 mg bosentan (as
Bosentan unless your doctor tells you to.
monohydrate).
Your doctor may tell you to reduce the
• The other ingredients are
dose over a few days before stopping
• Tablet core: maize starch,
completely.
pregelatinized starch, sodium starch
glycolate (type A), povidone,
If you have any further questions on the
glycerol dibehenate and
use of this medicine, ask your doctor or
magnesium stearate.
pharmacist.
• Film-coat: hypromellose, triacetin,
talc, titanium dioxide, yellow iron
4 Possible side effects
oxide (E172), red iron oxide (E172)
and ethylcellulose aqueous
Like all medicines, this medicine can
dispersion (containing
cause side effects, although not
ethylcellulose, sodium lauryl
everybody gets them.
sulphate and cetyl alcohol).
The most serious side effects with
bosentan are:
• abnormal liver function which may
affect more than 1 in 10 people
• anaemia (low blood value) which may
affect up to 1 in 10 people. Anaemia
may occasionally require blood
transfusion.
Your liver and blood values will be
monitored during treatment with
Bosentan (see section 2). It is important
that you have these tests as ordered by
your doctor.

What Bosentan looks like and contents of
the pack
Each 62.5 mg Bosentan film-coated
tablets are pink-orange, round (6 mm in
diameter), biconvex, with debossing 62.5
on one side.
Each 125 mg Bosentan film-coated tablets
are pink-orange, oval (11 mm x 5 mm in
dimensions), with debossing 125 on one
side.

Bosentan 62.5 mg is available in pack
sizes of 7, 14, 28, 56, 60 and 112
film-coated tablets in blisters or 7x1,
Signs that your liver may not be working 14x1, 28x1, 56 x1, 60x1 and 112x1
properly include:
film-coated tablets in perforated
• nausea (urge to vomit)
unit-dose blisters.
• vomiting
Bosentan 125 mg is available in pack
• fever (high temperature)
sizes of 7, 14, 28, 56, 60 and 112
• pain in your stomach (abdomen)
film-coated tablets in blisters or 7x1,
• jaundice (yellowing of your skin or the 14x1, 28x1, 56 x1, 60x1 and 112x1
whites of your eyes)
film-coated tablets in perforated
• dark-coloured urine
unit-dose blisters.
• itching of your skin
• lethargy or fatigue (unusual tiredness Not all pack sizes may be marketed.
or exhaustion)
Marketing Authorisation Holder
• flu-like syndrome (joint and muscle
TEVA UK Limited, Eastbourne, BN22 9AG,
pain with fever).
UK
If you notice any of these signs tell your
Manufacturer
doctor immediately.
PLIVA Hrvatska d.o.o. (PLIVA Croatia
Ltd.), Prilaz baruna Filipovica 25, Zagreb,
Other side effects:
10000, Croatia
Very common: may affect more than one
This leaflet was last revised in 07/2017.
in 10 people
• headache
PL 00289/1847
• oedema (swelling of the legs and
ankles or other signs of fluid retention). PL 00289/1848
Common: may affect up to one in 10
people
• flushed appearance or redness of skin
• hypersensitivity reactions (including
skin inflammation, itching and rash)
• gastroesophageal reflux disease (acid
reflux)
• diarrhoea
• syncope (fainting)
• palpitations (fast or irregular heart
beats)
• low blood pressure
• nasal congestion.
Uncommon: may affect up to one in 100
people
• thrombocytopenia (low number of
blood platelets)

EAS716a

180 x 600

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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