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BOSENTAN DR REDDYS 125 MG FILM-COATED TABLETS

Active substance(s): BOSENTAN MONOHYDRATE

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Package Leaflet: Information for the User
Bosentan 62.5 mg, 125 mg Film-Coated Tablets
Bosentan
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.
2.
3.
4.
5.
6.
1.

What Bosentan is and what it is used for
What you need to know before you take Bosentan
How to take Bosentan
Possible side effects
How to store Bosentan
Contents of the pack and other information

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.

2. What you need to know before you take
Bosentan
Do not take Bosentan:






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’
if you are taking ciclosporine A (a medicine used after a
transplant or to treat psoriasis).

If any of these apply to you, tell your doctor.

Warnings and precautions
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 have been found to have
abnormal liver function tests and anaemia (low haemoglobin).
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.
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. 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. 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
There is only limited clinical experience in children with
pulmonary arterial hypertension under 2 years of age. Please
see also section 3 ‘How to take Bosentan’.

Other medicines and Bosentan
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. It is especially
important to tell your doctor if you are taking:
 ciclosporine 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.

Pregnancy, breast-feeding and fertility
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
reliable contraceptive methods while taking Bosentan. Because
Bosentan 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 and are of child-bearing age.
Tell your doctor immediately if you become pregnant while you
are taking Bosentan 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 is prescribed for
you, because it is not known whether this medicine passes into
breast milk.
Fertility
Fertility studies in animals showed no effects on sperm
parameters or fertility.

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
and affect your ability to drive and use machines. Therefore, if
you feel dizzy while taking Bosentan, do not drive or operate any
tools or machines.

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

Recommended dose
Adults
The treatment in adults is usually started for the first 4 weeks
with 62.5 mg twice daily (morning and evening). From then, your
doctor will usually advise you to take a 125 mg tablet twice daily,
depending on how you react to Bosentan.
Children and adolescents
For children 2 years and older, treatment with Bosentan is
usually started with 2 mg per kg bodyweight twice daily (morning
and evening). Your doctor will advise you on your dosing.
Please note that Bosentan is also available as a dispersible
32 mg tablet formulation, which may make correct dosing easier
for children and patients with low body weight or difficulties
swallowing 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.

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

If you take more Bosentan 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
If you forget to take Bosentan, 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 forgotten tablets.

If you stop taking Bosentan
Suddenly stopping your treatment with Bosentan may lead to
your symptoms getting worse. Do not stop taking Bosentan
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 the 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 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.
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
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
Very common (may affect more than one in 10 people)
 headache
 oedema (swelling of the legs and ankles or other signs of
fluid retention)
Common (may affect up to one in 10 people)
 flushed appearance or redness of skin
 hypersensitivity reactions (including skin inflammation,
itching and rash)
 gastrooesophageal reflux disease (acid reflux)
 diarrhoea
 syncope (fainting)
 palpitations (fast or irregular heart beats)
 low blood pressure

Uncommon (may affect up to one 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) – if this occurs tell your doctor immediately
Rare (may affect up to one in 1,000 people)
 serious allergic reaction (anaphylaxis) causing flushing,
itching, feeling or being sick and swelling (angioedema)
most commonly around the eyes, lips, tongue or throat – if
these occur, seek immediate medical help
 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 treated with
Bosentan 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
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 the blister pack after EXP. The expiry date refers
to the last day of that month.
This medicine does not need any special storage conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Bosentan tablets contain
The active substance is bosentan as monohydrate. Each tablet
contains 62.5 mg or 125 mg bosentan (as monohydrate).
The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate, povidone, glycerol
dibehenate and magnesium stearate. The film coating contains
hypromellose (E464), titanium dioxide (E171), triacetin, talc,
ethylcellulose, cetyl alcohol, sodium lauryl sulfate, iron oxide
yellow (E172) and iron oxide red (E172).

What Bosentan tablets look like and contents of the
pack
Bosentan 62.5 mg tablets are light orange, film-coated, round
biconvex tablets (diameter 6 mm), debossed with ‘62.5’ on one
side and plain on the other side.
Bosentan 125 mg tablets are light orange, film-coated, oval
biconvex tablets (dimensions 11 mm x 5 mm), debossed with
‘125’ on one side and plain on the other side.
Bosentan 62.5 mg tablets are available in blister packs of 14, 56
or 112 tablets. Bosentan 125 mg tablets are available in blister
packs of 28, 56 or 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD, United Kingdom

This leaflet was last revised in 11/2014

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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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