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BOSENTAN ACTAVIS 62.5MG FILM-COATED TABLETS

Active substance(s): BOSENTAN

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Package leaflet: Information for the user

Bosentan 62.5mg and 125mg
Film-coated Tablets
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.
•  The full name of this medicine is Bosentan
62.5mg, 125mg Film-coated Tablets but
within the leaflet it will be referred to as
Bosentan Tablets.

Tests your doctor will do during treatment

What is in this leaflet
1 What Bosentan Tablets are and what
they are used for
2 What you need to know before you
take Bosentan Tablets
3 How to take Bosentan Tablets
4 Possible side effects
5 How to store Bosentan Tablets
6 Contents of the pack and other
information

Blood tests for anaemia

1

 hat Bosentan Tablets are and what
W
they are used for

Bosentan Tablets contain bosentan which
blocks naturally occurring hormone called
endothelin-1 (ET-1), which causes blood vessels
to narrow. Bosentan Tablets therefore causes
blood vessels to expand and belongs to the
class of medicines called “endothelin receptor
antagonists”.

Bosentan Tablets are used to treat:

•P
 ulmonary 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 Tablets 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 Tablets are 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 Tablets are 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.
•D
 igital ulcers (sores on the fingers and toes)
in adult patients with a condition called
scleroderma. Bosentan Tablets reduce the
number of new finger and toe ulcers that
appear.
2

 hat you need to know before you
W
take Bosentan Tablets

Do not take Bosentan Tablets:

• i f you are allergic to bosentan or any of the
other ingredients of this medicine (listed in
section 6)
• i f you have liver problems (ask your doctor)
• i f you are pregnant, or could get pregnant
because you are not using reliable
contraceptive methods. Please read the
information under “contraceptives” and “Other
medicines and Bosentan Tablets
• i f you are taking ciclosporin A (a medicine
used after a transplant or to treat psoriasis).
If any of these apply to you, tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Bosentan Tablets.

Tests your doctor will do before treatment
• a blood test to check your liver function
• a blood test to check for anaemia (low
haemoglobin)
• a pregnancy test if you are a woman of childbearing potential
Some patients taking Bosentan Tablets have
been found to have abnormal liver function
tests and anaemia (low haemoglobin).

During treatment with Bosentan Tablets, your
doctor will arrange for regular blood tests to
check for changes in your liver function and
haemoglobin level.

For all these tests please refer also to the
Patient Alert Card (inside your pack of Bosentan
Tablets). It is important that you have these
regular blood tests as long as you are taking
Bosentan Tablets. We suggest you 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 Tablets. After an
increase in dose an additional test will be done
after 2 weeks.
These will be done every month for the first
4 months of treatment, then every 3 months
after that, as patients taking Bosentan Tablets
may get anaemia.
If these results are abnormal, your doctor may
decide to reduce your dose or stop treatment
with Bosentan Tablets and to perform further
tests to investigate the cause.

Children and adolescents

Bosentan Tablets are not recommended in
paediatric patients with systemic sclerosis and
ongoing digital ulcer disease. Bosentan Tablets
should also not be used in children with a body
weight below 31kg and certain other weight
ranges with pulmonary arterial hypertension.
Please see also section 3. How to take Bosentan
Tablets.

Other medicines and Bosentan Tablets

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:
• ciclosporin A (a medicine used after
transplants and to treat psoriasis), which must
not be used together with Bosentan Tablets
• sirolimus or tacrolimus, which are medicines
used after transplants, as these are not
recommended to be used together with
Bosentan Tablets
• glibenclamide (a diabetes medicine),
rifampicin (a tuberculosis medicine) or
fluconazole (a medicine against fungal
infections), nevirapine (HIV medicine) as these
medicines are not recommended to be used
together with Bosentan Tablets
• other medicines for the treatment of
HIV infection, which may require special
monitoring if used together with Bosentan
Tablets
• hormonal contraceptives, which are not
effective as the sole method of contraception
when you take Bosentan Tablets. 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.

Driving and using machines

Bosentan Tablets has no or negligible influence
on the ability to drive and use machines.
However, Bosentan Tablets can induce
hypotension (decrease of your blood pressure)
which can make you feel dizzy, affect your
vision and affect your ability to drive and use
machines. Therefore, if you feel dizzy or that
your vision is blurred while taking Bosentan
Tablets, do not drive or operate any tools or
machines.

Women of childbearing age

Do NOT take Bosentan Tablets if you are
pregnant or planning to become pregnant.

Pregnancy tests

Bosentan Tablets 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
Tablets, and regularly while you are taking
Bosentan Tablets.

Contraceptives

If it is possible that you could become pregnant,
use a reliable form of birth control
(contraception) while you are taking Bosentan
Tablets. Your doctor or gynaecologist will
advise you about reliable contraceptive
methods while taking Bosentan Tablets.
Because Bosentan Tablets may make hormonal
contraception (e.g. oral, injection, implant, or
skin patches) ineffective, this method on its own
is not reliable. Therefore, if you use hormonal
contraceptives you must also use a barrier
method (e.g. female condom, diaphragm,
contraceptive sponge, or your partner must also
use a condom). Inside your pack of Bosentan
Tablets you will find a Patient Alert Card. You
should complete this card and take it to your
doctor at your next visit so that your doctor or
gynaecologist can assess whether you need
additional or alternative reliable contraceptive
methods. Monthly pregnancy tests are
recommended while you are taking Bosentan
Tablets and are of childbearing age.

Continued top of next column

Continued over page

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Date received: 16.05.17

Colours

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1. Black

1.

2.

2.

3.

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4.
5.
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Uncommon (may affect up to 1 in 100 people):
• thrombocytopenia (low number of blood
platelets)
• neutropenia/leukopenia (low number of white
blood cells)
• elevated liver function tests with hepatitis
(inflammation of the liver) including possible
exacerbation of underlying hepatitis and/or
jaundice (yellowing of the skin or the whites of
the eyes).

• Tell your doctor immediately if you become
pregnant while you are taking Bosentan
Tablets, or plan to become pregnant in the
near future.

Breast-feeding

Tell your doctor immediately if you are
breast-feeding. You are advised to stop breastfeeding if Bosentan Tablets is prescribed for you,
because it is not known whether this medicine
passes into breast milk.

Rare (may affect up to 1 in 1,000 people):
• anaphylaxis (general allergic reaction),
angioedema (swelling, most commonly around
the eyes, lips, tongue or throat)
• cirrhosis (scarring) of the liver, liver failure
(serious disturbance of liver function).

Fertility

If you are a man taking Bosentan Tablets, it is
possible that this medicine may lower your
sperm count. It cannot be excluded that this
may affect your ability to father a child. Talk
to your doctor if you have any questions or
concerns about this.
3

Not known (frequency cannot be estimated
from the available data):
• Blurred vision

How to take Bosentan Tablets

Side effects in children and adolescents

Treatment with Bosentan Tablets should only
be started and monitored by a doctor who has
experience in the treatment of PAH or systemic
sclerosis. Always take this medicine exactly
as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.

The side effects that have been reported in
children with Bosentan Tablets are the same as
those in adults.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard

Bosentan Tablets with food and drink

Bosentan Tablets can be taken with or without
food.

Recommended dose
Adult
The treatment in adults is usually started for the
first 4 weeks with 62.5mg twice daily (morning
and evening), from then your doctor will usually
advise you to take a 125mg tablet twice daily,
depending on how you react to Bosentan
Tablets.

By reporting side effects you can help provide
more information on the safety of this medicine.
5

Do not use this medicine after the expiry date
which is stated on the carton and on the blister
after “EXP”. The expiry date refers to the last day
of that month.

Children and adolescents
The dose recommendation in children is only for
PAH. Treatment with Bosentan Tablets is usually
started with 2mg per kg bodyweight twice daily
(morning and evening); however, some doses
of bosentan are not possible in children with
a body weight below 31kg and certain other
weight ranges. For such patients a bosentan
tablet with lower strength is needed. Your
doctor will advise you on your dosing.

Do not store above 30°C.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away any medicines
you no longer use. These measures will help to
protect the environment.

How to take Bosentan Tablets

Tablets should be taken (morning and evening),
swallowed with water. The tablets can be taken
with or without food.

If you take more Bosentan Tablets than
you should

If you take more tablets than you have been
told to take, contact your doctor immediately.

If you forget to take Bosentan Tablets

If you forget to take Bosentan Tablets, take a
dose as soon as you remember, then continue
to take your tablets at the usual times. Do not
take a double dose to make up for a forgotten
tablet.

If you stop taking Bosentan Tablets

Suddenly stopping your treatment with
Bosentan Tablets may lead to your symptoms
getting worse. Do not stop taking Bosentan
Tablets unless your doctor tells you to. Your
doctor may tell you to reduce the dose over a
few days before stopping completely.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The most serious side effects with Bosentan
Tablets 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 Tablets (see
section 2). It is important that you have these
tests as ordered by your doctor.
Signs that your liver may not be working
properly include:
• nausea (urge to vomit)
• vomiting
• fever (high temperature)
• pain in your stomach (abdomen)
• jaundice (yellowing of your skin or the whites
of your eyes)
• dark-coloured urine
• itching of your skin
• lethargy or fatigue (unusual tiredness or
exhaustion)
• flu-like syndrome (joint and muscle pain with
fever).

How to store Bosentan Tablets

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

6

 ontents of the pack and other
C
information

What Bosentan Tablets contain

• The active substance is bosentan as
monohydrate. Each tablet contains 62.5mg of
bosentan (as monohydrate).
• The active substance is bosentan as
monohydrate. Each tablet contains 125mg of
bosentan (as monohydrate).
Other ingredients:
The tablet core: maize starch, pregelatinised
starch, sodium starch glycollate, povidone,
glycerol dibehenate, magnesium stearate.
The film-coat: poly(vinyl alcohol) (E1203), talc
(E553b), titanium dioxide (E171), macrogol
(E1521), iron oxide yellow (E172), iron oxide red
(E172).

What Bosentan Tablets looks like and
contents of the pack

Bosentan 62.5mg Film-coated Tablets are
pale yellow coloured, 6mm, round, biconvex,
debossed with “111” on one side and “A” on the
other side.
Bosentan 125mg Film-coated Tablets are pale
yellow coloured, 10.7mm x 5.1mm capsule
shaped, biconvex, debossed with “117” on one
side and “A” on the other side.
The blister packs contain 56 film-coated tablets.
Marketing authorisation holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma – Dupnitsa AD
3, Samokovsko Shose Str.
2600 Dupnitsa
Bulgaria
This leaflet was last revised in May 2017.

If you would like a
leaflet with larger text,
please contact
01271 385257.

If you notice any of these signs tell your doctor
immediately.

Other side effects:
Very common (may affect more than 1 in 10
people):
• headache
• oedema (swelling of the legs and ankles or
other signs of fluid retention).
Common (may affect up to 1 in 10 people):
• flushed appearance or redness of skin
• hypersensitivity reactions (including skin
inflammation, itching and rash)
• stuffy nose
• gastro-oesophageal reflux disease (acid reflux)
• diarrhoea
• syncope (fainting)
• palpitations (fast or irregular heartbeats)
• low blood pressure.
Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

BBBA0364

Bosentan 6.25mg & 125mg 56 Film-coated Tablets PIL - UK
approved for print/date

Proof Round

7

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0364

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
15.12.16
25.05.17
S.Anson

Dimensions:
190 x 600
Min Body Text Size: 11pts
Supplier:
Actavis Bulgaria
Dupnitsa

Date sent:
15.12.16 + 15.05.17
Date received: 16.05.17

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

+ Expand Transcript

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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