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BOSENTAN ACTAVIS 125MG 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.

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

1.

What Bosentan Tablets are and what they are used for

Bosentan Tablets contain bosentan which blocks naturally occurring hormone called endothelin-1 (ET1), 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:
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 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.
-

Digital 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.

What you need to know before you take Bosentan Tablets

Do not take Bosentan Tablets:
1

-

-

if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
if you have liver problems (ask your doctor)
if 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
if you are taking cyclosporine 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 child-bearing potential
Some patients taking Bosentan Tablets have been found to have abnormal liver function tests and
anaemia (low haemoglobin).
Tests your doctor will do during treatment
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.
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 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 31 kg 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:
cyclosporine 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 (an 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
2

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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 and affect your ability to drive and use machines. Therefore, if you feel dizzy 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.
-

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 breast feeding if
Bosentan Tablets is prescribed for you, because it is not known whether this medicine passes into breast
milk.
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.

How to take Bosentan Tablets

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.
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
3

evening), from then your doctor will usually advise you to take a 125mg tablet twice daily, depending on
how you react to Bosentan Tablets.
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 31 kg and certain other weight ranges.
For such patients a bosentan tablet with lower strength is needed. Your doctor will advise you on your
dosing.
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).
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).
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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
gastrooesophageal reflux disease (acid reflux)
diarrhoea
syncope (fainting)
palpitations (fast or irregular heartbeats)
low blood pressure.
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) and/or jaundice
(yellowing of the skin or the whites of the eyes).
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).
Side effects in children and adolescents
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 or pharmacist. 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
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Bosentan Tablets

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

6.

Contents of the pack and other information

What Bosentan Tablets contain
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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:
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maize starch, pregelatinised starch, sodium starch glycollate, povidone, glycerol dibehenate,
magnesium stearate.
The film-coat
hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron
oxide red (E172), ethylcellulose.
What Bosentan Tablets looks like and contents of the pack
Bosentan Tablets 62.5mg film-coated tablets are pale yellow coloured, round, biconvex, debossed with
“111” on one side and “A” on the other side.
Bosentan Tablets 125mg film-coated tablets are pale yellow coloured, capsule shaped, biconvex,
debossed with “117” on one side and “A” on the other side.
The blister packs contain 10, 14, 30, 56, 60 and 112 film coated tablets.
Not all pack sizes may be marketed.
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 July 2015.

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

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK

Pil Spec no

6

Patient Alert Card

Blood Test for Liver Function

Your monthly liver blood test schedule:

Some patients taking Bosentan Tablets were found to
have abnormal liver function tests. During treatment
with Bosentan Tablets, your doctor will arrange for
regular blood tests to check for changes in your liver
function. Remember to have your liver blood test every
month. After an increase in dose, an additional test will
be done after 2 weeks.

Jan__________ May_________ Sep_________
Feb__________ Jun_________ Oct__________
Mar__________ Jul_________ Nov_________

Pregnancy
Bosentan Tablets may harm the development of the
foetus. Therefore, you should not take Bosentan Tablets
if you are pregnant and you should also not become
pregnant while taking Bosentan Tablets. Moreover, if
you are suffering from pulmonary hypertension disease,
the occurrence of a pregnancy can severely deteriorate
the symptoms of your disease. If you suspect you may
be pregnant, tell your doctor or gynaecologist.

Your name:___________________________________
Prescribing doctor:_____________________________

Apr__________ Aug_________ Dec_________
If you have questions about Bosentan Tablets ask your
doctor.

Date of first monthly test:

If you are a female patient of child bearing age read
this page carefully

Important Safety Reminders for Patients taking
Bosentan Tablets (bosentan)
This card contains important information about
Bosentan Tablets. Please read this card carefully before
starting your treatment with Bosentan Tablets.

Contraception
Birth control based on hormones, such as oral
contraceptives or birth control pills, hormone injections,
implants, or birth control skin patches don’t reliably
prevent pregnancy in women who are taking Bosentan
Tablets. You need to use a barrier form of birth control
like a condom, diaphragm or vaginal sponge, in
addition to any of these kinds of hormonal birth control.
Be sure to discuss any questions you may have with
your doctor or your gynaecologist.
Complete the details on the back of this card and take it
to your doctor or gynaecologist at your next visit.
You should have a pregnancy test before initiation of
Bosentan Tablets and every month during the treatment
even if you think that you are not pregnant.
Date of first monthly test:

Contraception
Do you currently use or take contraceptives?
Yes

No

If Yes, write the names of these here:

Take this card to your doctor or your gynaecologist at
your next visit and he/she will be able to advise you on
whether you need to use additional or alternative
contraceptive methods.

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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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