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BOSENTAN AMNEAL 62.5 MG FILM-COATED TABLET

Active substance(s): BOSENTAN MONOHYDRATE / BOSENTAN MONOHYDRATE

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Bosentan Tablets - UK - PIL

Review - 1

Bosentan
film-coated tablets
PM-0000

Other medicines and Bosentan

Bosentan 62.5 mg film-coated tablets
Bosentan 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. 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.
 Digital ulcers: (sores on the fingers and toes) in adult patients with a condition called
scleroderma. Bosentan reduces the number of new finger and toe ulcers that appear.

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 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.
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:
Bosentan is not recommended in paediatric patients with systemic sclerosis and ongoing
digital ulcer disease. Please see also section 3, How to take Bosentan.

Important Safety Alerts for Patients taking

Bosentan
This card contains important information about Bosentan. Please read this card carefully before
starting your treatment with Bosentan.
Your name:__________________________________________________
Prescribing doctor: ________________________________________
If you have questions about Bosentan ask to your doctor.
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

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:
• 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.
Bosentan with food and drink
Bosentan can be taken with or without food.
Pregnancy, breast-feeding and fertility
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
If you are a man taking Bosentan, 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.
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 to drive and use machines. Therefore, if you feel
dizzy or that your vision is blurred 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 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.
Recommended dose
Adults
The treatment in adults is usually started for the first 4 weeks with the 62.5 mg tablets 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
The dose recommendation in children is only for PAH. For children aged 1 year 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.
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.
Take the tablets in the mornings and evenings and swallow them 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 this medicine, ask your doctor or pharmacist.

If you are a woman of child bearing age read this page carefully
Pregnancy
Bosentan may harm the development of the foetus. Therefore, you must not take Bosentan if
you are pregnant and you must also not become pregnant while taking Bosentan.
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.
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. 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 and every month during the
treatment even if you think that you are not pregnant.
Date of first monthly test: _________________________________

Size : 240 x 520 mm, Colour:
Black,
Key line(Not to Print)
NOTE: Actual Perforation require for Patient alert card
Minimum Font Size 9 pt
Date: 18/01/17

Front Side

Pharma code position can chenge as per Supplier’s m/c requirement & additional small pharma code may appear on the front /back panel

Package leaflet: Information for the user

Bosentan Tablets - UK - PIL

4. Possible side effects

Review - 1

What Bosentan looks like and contents of the pack

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:

62.5 mg:
Orange, round, biconvex, film coated tablets of about 6 mm, debossed with “A53” on one side
and plain on the other side.
125 mg:
Orange, oval, biconvex, film coated tablets of about 11 mm x 5.1 mm, debossed with “A54” on
one side and Plain on the other side.
Bosentan is available in,
Blister packs consisting of PVC/Aclar /Aluminium containing:
- For 62.5 mg strength: 14, 28, 30, 50, 56, 60, 90, 98 and 112 film-coated tablets.
- For 125 mg strength: 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 and 112 film-coated tablets.
Perforated unit dose blister (for 62.5 mg): 14x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1 and
112x1 film-coated tablets.
Perforated unit dose blister (for 125 mg): 10x1, 14x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1,
98x1, 100x1 and 112x1 film-coated tablets.
HDPE container, Child resistant Polypropylene closure with a desiccant containing 60 and 100
film-coated tablets.
Not all pack sizes may be marketed.

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)
• Gastrooesophageal reflux disease (acid reflux)
• Diarrhoea
• Syncope (fainting)
• Palpitations (fast or irregular heart beats)
• Low blood pressure
• Nasal congestion
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)
Rare: may affect up to 1 in 1000 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)

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
Amneal Netherlands B.V.,
Emmaplein 4D,
’s-Hertogenbosch,
5211 VW,
The Netherlands
Amneal Nordic ApS
Kanalholmen 14-18
2650 Hvidovre
Denmark
This leaflet was last revised in January 2017

Blurred vision have also been reported at an unknown frequency (frequency cannot be
estimated from the available data).
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 MHRA 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 on the blister
after “EXP".
For Bosentan 62.5 mg tablets
PVC/Aclar/Aluminium blisters:
Do not store above 30°C.
HDPE bottles:
This medicine does not require any special storage conditions.
For Bosentan 125 mg tablets
PVC/Aclar/Aluminium blisters and HDPE bottles:
This medicine does not require 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 to protect the
environment.

6. Contents of the pack and other information
What Bosentan contains
• The active substance is bosentan as monohydrate.
Each tablet contains 62.5 mg of bosentan (as monohydrate).
Each tablet contains 125 mg of bosentan (as monohydrate).
• The other ingredients are:
Tablet core: Maize Starch, Sodium Starch Glycolate Type A, Starch, Pregelatinized,
Povidone, Glycerol Dibehenate, Magnesium Stearate.
Film-Coating: Hypromellose, Titanium Dioxide (E171), Triacetin, Talc, Iron Oxide Yellow
(E172), Ethyl Cellulose, Iron Oxide Red (E172)

Contraception

Remember to have your liver blood test every month.
Do you currently use or take contraceptives?
After an increase in dose, an additional test will be done after 2 weeks.
 Yes

 No

Date of first monthly test: _________________________________

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.

Your monthly liver blood test schedule:
 Jan ______
 Feb ______
 Mar ______
 Apr ______

 May
 Jun
 Jul
 Aug

______
______
______
______

 Sep _____
 Oct _____
 Nov _____
 Dec _____

Blood Test for Liver Function
Some patients taking Bosentan were found to have abnormal liver function tests. During
treatment with Bosentan, your doctor will arrange for regular blood tests to check for changes
in your liver function.

Size : 240 x 520 mm, Colour:
Black,
Key line(Not to Print)
NOTE: Actual Perforation require for Patient alert card
Minimum Font Size 9 pt
Date: 18/01/17

Back Side

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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