Bosentan Sandoz Gmbh

Package Leaflet: Information for the Patient

Bosentan Sandoz GmbH, 125 mg, Film-Coated Tablets

Bosentan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of further questions, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Bosentan Sandoz GmbH and what is it used for
• 2. Important information before taking Bosentan Sandoz GmbH
• 3. How to take Bosentan Sandoz GmbH
• 4. Possible side effects
• 5. How to store Bosentan Sandoz GmbH
• 6. Contents of the pack and other information

1. What is Bosentan Sandoz GmbH and what is it used for

Bosentan Sandoz GmbH contains bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), causing blood vessels to constrict. Therefore, Bosentan Sandoz GmbH causes blood vessels to dilate and belongs to a group of so-called "endothelin receptor antagonists".
Bosentan Sandoz GmbH is used to treat:

• pulmonary arterial hypertension (PAH). PAH is a disease characterized by significant constriction of blood vessels in the lungs, leading to high blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. This high pressure reduces the amount of oxygen that can enter the blood in the lungs, making physical activity difficult. Bosentan Sandoz GmbH dilates the pulmonary arteries, making it easier for the heart to pump blood. As a result, the pressure decreases and the symptoms subside.

Bosentan Sandoz GmbH is used to treat patients with pulmonary arterial hypertension (PAH) of class III to improve exercise capacity (ability to exercise) and alleviate symptoms. The "class" reflects the severity of the disease: class III is associated with significant limitation of physical activity. Some improvement has also been shown in patients with PAH class II. Class II is associated with mild limitation of physical activity.
PAH, for which Bosentan Sandoz GmbH is indicated, may be:

• primary (without a known cause or familial);
• caused by scleroderma (also known as systemic scleroderma - a disease in which there is abnormal growth of connective tissue that supports the skin and other organs);
• caused by congenital heart defects associated with blood leaks through the heart and lungs.
• digital ulcers(sores on fingers and toes) in adult patients with systemic scleroderma. Bosentan Sandoz GmbH reduces the number of new digital ulcers on fingers and toes.

2. Important information before taking Bosentan Sandoz GmbH

When not to take Bosentan Sandoz GmbH

if the patient is allergic to bosentanor any of the other ingredients of this medicine (listed in section 6);
if the patient has liver function disorders(should consult a doctor);
if the patient is pregnant or may become pregnant, as they are not using effective contraception (should read the information in the "Contraception" and "Bosentan Sandoz GmbH and other medicines" sections);
if the patient is taking cyclosporin A(a medicine used after transplantation or in the treatment of psoriasis).
If any of the above situations apply to the patient, they should inform their doctor.

Warnings and precautions

Before taking Bosentan Sandoz GmbH, the patient should discuss it with their doctor or pharmacist.

Tests that the doctor will perform before starting treatment

blood test to assess liver function
blood test to rule out anemia (low hemoglobin level)
pregnancy test in women of childbearing age
In some patients taking Bosentan Sandoz GmbH, abnormal liver function test results and anemia (low hemoglobin level) have been observed.

Tests that the doctor will perform during treatment

During Bosentan Sandoz GmbH treatment, the doctor will prescribe regular blood tests to monitor changes in liver function and hemoglobin levels.
A description of all these tests can also be found in the Warning Card (included in the medicine packaging).
It is essential for the patient to perform regular blood tests while taking Bosentan Sandoz GmbH. The date of the last and next planned blood test (according to the doctor's instructions) should be recorded in the Warning Card.
Blood tests to assess liver function
These tests are performed once a month throughout the entire period of Bosentan Sandoz GmbH treatment. After increasing the dose of the medicine, an additional test should be performed after 2 weeks.
Blood tests to rule out anemia
These tests are performed once a month for the first 4 months of treatment, then every 3 months, as anemia may occur in patients taking Bosentan Sandoz GmbH. If the test results are abnormal, the doctor may decide to reduce the dose or stop taking Bosentan Sandoz GmbH and perform additional tests to determine the cause of anemia.
Children and adolescents
Bosentan Sandoz GmbH is not recommended for children and adolescents with systemic scleroderma and digital ulcers. Bosentan Sandoz GmbH should also not be used in children with pulmonary arterial hypertension with a body weight of less than 31 kg. See also section 3 "How to take Bosentan Sandoz GmbH".

Bosentan Sandoz GmbH and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. It is particularly important to inform the doctor about the use of:
cyclosporin A (a medicine used after transplantation or in the treatment of psoriasis), which should not be used with Bosentan Sandoz GmbH;
sirolimus or tacrolimus (medicines used after transplantation), which are not recommended for use with Bosentan Sandoz GmbH;
glibenclamide (a medicine used to treat diabetes), rifampicin (a medicine used to treat tuberculosis), fluconazole (a medicine used to treat fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (a medicine used to treat HIV infections), which are not recommended for use with Bosentan Sandoz GmbH;
other medicines used to treat HIV infections, as concomitant use with Bosentan Sandoz GmbH may require special monitoring;
hormonal contraceptives, as they are ineffective as the only method of contraception during Bosentan Sandoz GmbH treatment. The patient should carefully read the information in the Warning Card included in the medicine packaging. The attending doctor and/or gynecologist will advise on the most suitable contraception method for the patient;
other medicines used to treat pulmonary hypertension: sildenafil and tadalafil;
warfarin (an anticoagulant medicine);
simvastatin (a medicine used to treat hypercholesterolemia).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Women of childbearing age
Bosentan Sandoz GmbH should notbe used in pregnant or planning-to-become-pregnant women.
Pregnancy tests
Bosentan Sandoz GmbH may harm the unborn child conceived before or during treatment. If the patient may become pregnant, the doctor will recommend a pregnancy test before starting Bosentan Sandoz GmbH treatment and regular repetition of the test during treatment.
Contraception
If the patient may become pregnant, they should use effective contraception while taking Bosentan Sandoz GmbH. The attending doctor or gynecologist will advise on the use of effective contraception during Bosentan Sandoz GmbH treatment. Since this medicine can make hormonal contraceptives ineffective (e.g., oral, injectable, implants, or patches), using only this method of contraception will be ineffective. Therefore, patients using hormonal contraceptives should also use a barrier method (such as a female condom, diaphragm, or contraceptive sponge) or their partner should also use a condom. The Warning Card included in the medicine packaging should be filled out and taken to the next doctor's visit so that the attending doctor or gynecologist can assess whether additional or other effective contraception methods are necessary. It is recommended that women of childbearing age perform a pregnancy test every month while taking Bosentan Sandoz GmbH.
The patient should immediately inform their doctor if they become pregnant while taking Bosentan Sandoz GmbH or plan to become pregnant in the near future.
Breastfeeding
Bosentan Sandoz GmbH passes into breast milk. Breastfeeding should be discontinued if Bosentan Sandoz GmbH is prescribed to the patient, as it is not known whether Bosentan Sandoz GmbH in breast milk can harm the child. The patient should discuss this with their doctor.
Fertility
If a man is taking Bosentan Sandoz GmbH, there is a possibility that the medicine may reduce the number of sperm in the semen. It cannot be excluded that this may affect the ability to father a child.
If the patient has any questions or concerns about this, they should consult their doctor.

Driving and using machines

Bosentan Sandoz GmbH has no or negligible influence on the ability to drive and use machines. Bosentan Sandoz GmbH may cause low blood pressure, which can cause dizziness, affect vision, and impair the ability to drive and use machines. Therefore, if dizziness or blurred vision occurs while taking Bosentan Sandoz GmbH, the patient should not drive or operate any tools or machines.

Bosentan Sandoz GmbH contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Bosentan Sandoz GmbH

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Bosentan Sandoz GmbH treatment should only be started and supervised by a doctor experienced in the treatment of pulmonary arterial hypertension or systemic scleroderma.

Recommended dose

Adults

In adult patients, treatment usually starts with 62.5 mg of bosentan twice a day (morning and evening) for 4 weeks, and then the doctor recommends taking a 125 mg tablet twice a day, depending on the patient's response to bosentan.

Use in children and adolescents

Dosing recommendations for children apply only to pulmonary arterial hypertension. In children aged 1 year and older, Bosentan Sandoz GmbH treatment usually starts with 2 mg/kg body weight twice a day (morning and evening). However, administering certain doses of bosentan to children with a body weight of less than 31 kg is not possible. In these cases, bosentan should be used in tablets with a lower strength. The doctor will recommend how to dose the medicine.
Bosentan is also available in soluble tablets of 32 mg, which facilitates proper dosing in children and patients with a low body weight or difficulty swallowing film-coated tablets.
If the patient feels that the effect of Bosentan Sandoz GmbH is too strong or too weak, they should consult their doctor to check if a dose change is necessary.

How to take Bosentan Sandoz GmbH

Tablets should be taken in the morning and evening, with a glass of water. Tablets can be taken with or without food.

Taking a higher dose of Bosentan Sandoz GmbH than recommended

In case of taking a higher dose of tablets than recommended, the patient should immediately consult their doctor.

Missing a dose of Bosentan Sandoz GmbH

If the patient forgets to take a dose of Bosentan Sandoz GmbH, they should take the missed dose as soon as they remember, and then continue taking the tablets at the usual times. The patient should not take a double dose to make up for the missed dose.

Stopping Bosentan Sandoz GmbH treatment

Suddenly stopping Bosentan Sandoz GmbH treatment may worsen symptoms. The patient should not stop taking this medicine without their doctor's advice. The doctor may recommend gradually reducing the dose over a few days before completely stopping the medicine.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bosentan Sandoz GmbH can cause side effects, although not everybody gets them.
The most serious side effects of Bosentan Sandoz GmbH are:

• abnormal liver function, which may occur in more than 1 in 10 people,
• anemia (low red blood cell count), which may occur in less than 1 in 10 people. Anemia may rarely require blood transfusion.

During Bosentan Sandoz GmbH treatment, the doctor will monitor liver function and blood morphology (see section 2). It is essential to perform these tests as recommended by the doctor.
Symptoms of abnormal liver function include:

• nausea (feeling sick),
• vomiting,
• fever (high temperature),
• abdominal pain (stomach pain),
• jaundice (yellowing of the skin or whites of the eyes),
• dark urine,
• itching of the skin,
• lethargy or fatigue (unusual tiredness or exhaustion),
• flu-like symptoms (joint and muscle pain with fever).

If the patient notices any of these symptoms, they should immediatelyconsult their doctor.
Other side effects
Very common(may affect more than 1 in 10people)
headache
edema (swelling of the legs and ankles or other signs of fluid retention)
Common(may affect less than 1 in 10people)
flushing (redness of the skin, including the face)
hypersensitivity reactions (including skin inflammation, itching, and rash)
gastroesophageal reflux disease (stomach acid flowing back into the esophagus)
diarrhea
fainting
palpitations (fast or irregular heartbeat)
low blood pressure
nasal congestion (blocked nose)
Uncommon(may affect less than 1 in 100people)
thrombocytopenia (low platelet count)
neutropenia and/or leukopenia (low white blood cell count)
increased liver function test results (liver inflammation, including possible worsening of existing liver inflammation) and/or jaundice (yellowing of the skin and whites of the eyes)
Rare(may affect less than 1 in 1000people)
anaphylactic reaction (generalized allergic reaction), angioedema (swelling, usually around the eyes, lips, tongue, or throat)
liver cirrhosis, liver failure (severe liver dysfunction)
There have also been reports of blurred vision with an unknown frequency (frequency cannot be estimated from the available data).

Side effects in children and adolescents

The side effects observed in children and adolescents are the same as those in adults.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bosentan Sandoz GmbH

The medicine should be stored out of 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 the month.
The batch number on the packaging is marked as "Lot".
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bosentan Sandoz GmbH contains

The active substance is bosentan (monohydrate).
Each film-coated tablet contains 125 mg of bosentan in the form of bosentan monohydrate (129.082 mg).
The other ingredients are: cornstarch, pregelatinized cornstarch, sodium carboxymethylcellulose (type A), povidone K30, poloxamer 188, colloidal silicon dioxide, glycerol dibehenate, magnesium stearate.
Coating (Opadry Orange 21K23007): hypromellose 2910, titanium dioxide (E 171), ethylcellulose, triacetin (E 1518), talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Bosentan Sandoz GmbH looks like and contents of the pack

Light orange, oval, biconvex tablets with dimensions of 11 x 5 mm.
The film-coated tablets are packaged in blisters of PVC/PVDC/Aluminum and placed in a carton.
Pack sizes:
14, 56, or 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer

Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Alle 1
39179 Barleben, Germany

For more information on this medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:01/2025
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