Bosentan Abdi: detailed information

Package leaflet: Information for the user

BOSENTAN ABDI 62.5 mg film-coated tablets, 125 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you:

Keep this leaflet. You may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful. If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BOSENTAN ABDI is and what it is used for

BOSENTAN ABDI tablets contain bosentan, which blocks a naturally occurring hormone in the body called endothelin-1 (ET-1) that causes narrowing of blood vessels. BOSENTAN ABDI therefore causes blood vessels to dilate and belongs to a class of medicines known as "endothelin receptor antagonists".

BOSENTAN ABDI is used to treat:

Pulmonary arterial hypertension (PAH): PAH is a disease characterized by severe narrowing of the blood vessels in the lungs, resulting in increased pressure in the blood vessels carrying blood from the heart to the lungs (pulmonary arteries). This pressure reduces the amount of oxygen that can pass into the blood through the lungs, making physical activity more difficult. BOSENTAN ABDI widens the pulmonary arteries, making it easier for the heart to pump blood through them. This leads to a reduction in blood pressure and an improvement in symptoms.

BOSENTAN ABDI is used to treat patients with pulmonary arterial hypertension (PAH) in WHO functional class III, to improve exercise capacity (ability to perform physical activity) and symptoms. The "class" reflects the severity of the disease: "class III" indicates marked limitation in physical activity.

Improvements have also been observed in some patients with PAH in class II. "Class II" indicates slight limitation in physical activity.

The PAH for which BOSENTAN ABDI is indicated may be:

primary (without an identifiable cause or familial);
caused by scleroderma (also known as systemic sclerosis, a disease characterized by abnormal growth of connective tissue supporting the skin and other organs);
caused by congenital (inborn) heart defects with shunts (abnormal passageways), leading to abnormal blood flow through the heart and lungs.

Digital ulcers: (sores on fingers and toes) in adult patients with a condition called scleroderma. BOSENTAN ABDI reduces the number of new ulcers developing on fingers and toes.

2. What you should know before taking BOSENTAN ABDI

Do not take BOSENTAN ABDI
if you are allergic to bosentan or to any of the other ingredients of this medicine (listed in
section 6)
if you have liver problems (consult your doctor)
if you are pregnant or could become pregnant because you are not using reliable contraceptive methods. Read
the information provided under “Contraceptives” and “Other medicines and BOSENTAN ABDI”
if you are being treated with cyclosporine A (a medicine used after organ transplantation or for the
treatment of psoriasis)
If any of these situations apply to you, talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking BOSENTAN ABDI.
Tests required by your doctor before starting treatment with BOSENTAN ABDI
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 age
Abnormal results in liver function tests and anaemia (low haemoglobin) have been observed in some patients
treated with BOSENTAN ABDI.
Tests your doctor will prescribe during treatment
During treatment with BOSENTAN ABDI, your doctor will regularly request blood tests to monitor any
changes in liver function and haemoglobin levels.
For all these tests, also refer to the Patient Information Card (included in the BOSENTAN ABDI package). It
is important that you undergo these blood tests at regular intervals throughout the entire period of BOSENTAN
ABDI administration. It is recommended that you record on the Patient Information Card the date of your most
recent test and also the date of your next scheduled test (ask your doctor for this date) so that you do not forget
the date of your next test.
Liver function blood tests
These will be performed every month for the entire duration of treatment with BOSENTAN ABDI. An additional
test will be performed 2 weeks after any dose increase.
Blood tests for anaemia
These will be performed every month for the first 4 months of treatment and then every 3 months, as patients
taking BOSENTAN ABDI may develop anaemia.
If these results are abnormal, your doctor may decide to reduce the dose or discontinue treatment with
BOSENTAN ABDI and perform further tests to determine the cause.
Children and adolescents
BOSENTAN ABDI is not recommended in paediatric patients with systemic sclerosis and active digital ulcers.
BOSENTAN ABDI must not be used in children weighing less than 31 kg with pulmonary arterial hypertension. See
also section 3 How to take BOSENTAN ABDI.
Other medicines and BOSENTAN ABDI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those obtained without a prescription. It is especially important to inform your doctor if you are taking:
cyclosporine A (a medicine used after organ transplants and for the treatment of psoriasis), which must not
be used together with BOSENTAN ABDI
sirolimus or tacrolimus, medicines used after transplants, whose use together with BOSENTAN ABDI is
not recommended
glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), fluconazole and
ketoconazole (medicines for fungal infections), nevirapine (a medicine for HIV), as the use of these
medicines together with BOSENTAN ABDI is not recommended
other medicines for the treatment of HIV infection, which may require special monitoring when used
together with BOSENTAN ABDI
hormonal contraceptives, which are not effective as the sole method of contraception when taking
BOSENTAN ABDI. Inside the BOSENTAN ABDI package, you will find a Patient Information Card that you
must read carefully. Your doctor and/or gynaecologist will determine the appropriate contraceptive method for
you
other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil
warfarin (an anticoagulant)
simvastatin (used to treat hypercholesterolaemia)
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask
your doctor or pharmacist for advice before taking this medicine.
Women of childbearing age
DO NOT take BOSENTAN ABDI if you are pregnant or planning to become pregnant.
Pregnancy test
BOSENTAN ABDI may harm the unborn child conceived before or during treatment. If you are a woman of
childbearing age, your doctor will ask you to take a pregnancy test before starting BOSENTAN ABDI and to
repeat it regularly during treatment with BOSENTAN ABDI.
Contraceptives
If you are a woman of childbearing age, use a reliable method of birth control (contraception) while taking
BOSENTAN ABDI. Your doctor or gynaecologist will advise you on a reliable contraceptive method while taking
BOSENTAN ABDI. Since BOSENTAN ABDI may render hormonal contraception ineffective (e.g. oral, injectable,
implantable contraceptives or contraceptive patches), this method alone 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 use a male condom).
Inside the BOSENTAN ABDI package, you will find a Patient Information Card. You must complete this card and
bring 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. It is recommended to perform a pregnancy test every
month during treatment with BOSENTAN ABDI if you are of childbearing age.
Inform your doctor immediately if you become pregnant during treatment with BOSENTAN ABDI or if you
plan to become pregnant in the near future.
Breast-feeding
Inform your doctor immediately if you are breast-feeding. It is recommended to stop breast-feeding if you are
prescribed BOSENTAN ABDI, as it is not known whether this medicine passes into breast milk.
Fertility
If you are a man taking BOSENTAN ABDI, this medicine may reduce sperm count. It cannot be ruled out that this
could impair your ability to father a child. Talk to your doctor if you have questions about this.
Driving and using machines
BOSENTAN ABDI does not affect or affects negligibly the ability to drive and use machines.
However, BOSENTAN ABDI may cause hypotension (low blood pressure), which may lead to dizziness, visual
disturbances, and may affect your ability to drive and use machines.
Therefore, if you experience dizziness or blurred vision while taking BOSENTAN ABDI, do not drive and avoid
using tools or machinery.

3. How to take BOSENTAN ABDI

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Treatment with BOSENTAN ABDI must be initiated and monitored only by a doctor experienced in the treatment of PAH or systemic sclerosis.

BOSENTAN ABDI with food and drinks
BOSENTAN ABDI may be taken on an empty stomach or with food.

Recommended dose
Adults
In adults, treatment usually starts with one 62.5 mg tablet taken twice daily (morning and evening) for the first 4 weeks; thereafter, your doctor will usually recommend increasing to one 125 mg tablet twice daily, depending on your response to BOSENTAN ABDI.

Children and adolescents
The recommended dose in children applies only for PAH. For children aged 1 year and older, treatment with BOSENTAN ABDI usually starts at a dose of 2 mg per kg of body weight, taken twice daily (morning and evening). However, certain doses are not suitable for children weighing less than 31 kg. For these patients, a bosentan tablet with a lower dosage strength is required. Your doctor will advise you on the appropriate dose.
Please note that bosentan is also available as 32 mg dispersible tablets, which allow for more accurate dosing in children, in patients with low body weight, or in patients who have difficulty swallowing film-coated tablets.

If you feel that the effects of BOSENTAN ABDI are too strong or too weak, speak with your doctor to determine whether your dose should be adjusted.

How to take BOSENTAN ABDI
Take the tablets (morning and evening) with water. The tablets may be taken on an empty stomach or with food.

If you take more BOSENTAN ABDI than you should
If you take more tablets than prescribed, contact your doctor immediately.

If you forget to take BOSENTAN ABDI
If you forget to take a dose of BOSENTAN ABDI, take one tablet as soon as you remember, then continue taking your tablets at the usual times. Do not take a double dose to make up for the missed tablet.

If you stop taking BOSENTAN ABDI
If you stop treatment with BOSENTAN ABDI suddenly, your symptoms may worsen. Do not stop treatment unless your doctor tells you to. Your doctor may instruct you to gradually reduce the dose over several days before completely stopping treatment with BOSENTAN ABDI.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most serious side effects associated with BOSENTAN ABDI are:
Liver function abnormalities, which may affect more than 1 in 10 people
Anaemia (reduction in blood test values), which may affect up to 1 in 10 people.
Occasionally, anaemia may require a blood transfusion.
Liver and blood test values must be monitored during treatment with BOSENTAN ABDI (see section 2). It is important that you undergo these checks as prescribed by your doctor.
Signs that your liver is not working properly include:
nausea (feeling like vomiting)
vomiting
fever (high temperature)
abdominal pain
jaundice (yellowing of the skin or whites of the eyes)
dark-coloured urine
skin itching
lethargy or fatigue (unusual tiredness or weakness)
influenza-like syndrome (joint and muscle pain with fever)
If you notice any of these symptoms, tell your doctor immediately.
Other side effects:
Very common (may affect more than 1 in 10 people):
Headache
Oedema (swelling of legs and ankles or other signs due to fluid retention)
Common (may affect up to 1 in 10 people):
Flushing or redness of the skin
Hypersensitivity reactions (including skin inflammation, itching, and skin rash)
Gastro-oesophageal reflux disease (acid reflux)
Diarrhoea
Syncope (fainting)
Palpitations (fast or irregular heartbeat)
Low blood pressure
Nasal congestion
Uncommon (may affect up to 1 in 100 people):
Thrombocytopenia (low number of platelets in the blood)
Neutropenia/leucopenia (low number of white blood cells in the blood)
Elevated liver function test results associated with hepatitis (liver inflammation), including possible worsening of pre-existing hepatitis and/or jaundice (yellowing of the skin or whites of the eyes)
Rare (may affect up to 1 in 1000 people):
Anaphylaxis (generalized allergic reaction), angioedema (swelling, more commonly around eyes, lips, tongue or throat)
Cirrhosis (liver scarring), liver failure (severe impairment of liver function)
Blurred vision has also been reported with unknown frequency (frequency cannot be estimated from the available data).
Side effects in children and adolescents
The side effects reported in children treated with BOSENTAN ABDI are the same as those observed in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BOSENTAN ABDI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BOSENTAN ABDI contains
BOSENTAN ABDI 62.5 mg film-coated tablets: The active substance is bosentan monohydrate.
Each tablet contains 62.5 mg of bosentan (equivalent to 64.541 mg of bosentan monohydrate).
BOSENTAN ABDI 125 mg film-coated tablets: The active substance is bosentan monohydrate.
Each tablet contains 125 mg of bosentan (equivalent to 129.082 mg of bosentan monohydrate).

Other components in the tablet are: maize starch, pregelatinized maize starch,
sodium starch glycolate Type A, povidone K30, poloxamer 188, colloidal anhydrous silica, glycerol dibehenate, and magnesium stearate.

The film coating contains Opadry Orange 21K23007 (containing hypromellose, titanium dioxide (E171), ethylcellulose, triacetin, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)).

Description of the appearance of BOSENTAN ABDI and contents of the pack
BOSENTAN ABDI 62.5 mg film-coated tablets are round, light orange, biconvex film-coated tablets 6 mm in diameter.
BOSENTAN ABDI 125 mg film-coated tablets are oval, light orange, biconvex film-coated tablets measuring 11 x 5 mm.

PVC/PVDC/Aluminum blisters containing 14 film-coated tablets.
The carton contains 56 film-coated tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
ABDI FARMA GmbH
Donnersbergstraße 4, 64646 Heppenheim, Germany

Responsible manufacturer for batch release
GE Pharmaceuticals Ltd.
Industrial Zone, ‘Chekanitza-South’ area
2140 Botevgrad
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: BOSENTAN ABDI 62.5 mg, filmomhulde tabletten
BOSENTAN ABDI 125 mg, filmomhulde tabletten
Italy: BOSENTAN ABDI