Bosentan Sandoz Farmaceutica 125 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Bosentan Sandoz Farmacéutica 62.5 mg film-coated tablets EFG

Bosentan Sandoz Farmacéutica 125 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Bosentan Sandoz Farmacéutica tablets contain bosentan, which blocks a natural hormone called endothelin-1 (ET-1) that causes narrowing of blood vessels. Bosentan therefore causes blood vessels to dilate and belongs to a class of medicines known as “endothelin receptor antagonists”.

Bosentan Sandoz Farmacéutica is used to treat:

• Pulmonary arterial hypertension (PAH): PAH is a disease characterized by severe narrowing of the blood vessels in the lungs, leading to increased blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that can enter 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 reduces blood pressure and relieves symptoms.

Bosentan is used for the treatment of patients with pulmonary arterial hypertension (PAH) in WHO functional class III to improve symptoms and exercise capacity (the ability to perform physical activity). The "class" reflects the severity of the disease: 'class III' indicates marked limitation of physical activity. Some improvements have also been observed in patients with PAH class II. 'Class II' indicates slight limitation of physical activity. The PAH for which bosentan is indicated may be:

• primary (where no cause is identified or is hereditary),

• caused by scleroderma (also called systemic sclerosis, a disease in which there is abnormal growth of connective tissue that supports the skin and other organs),

• caused by congenital heart defects (present from birth) with shunts (abnormal connections) that cause abnormal blood flow between the heart and lungs.

• Digital ulcers: (ulcers on the fingers and toes) in adult patients suffering from a disease called scleroderma. Bosentan reduces the number of new digital ulcers (on hands and feet) that develop.

2. What you need to know before taking Bosentan Sandoz Farmacéutica

Do not take Bosentan Sandoz Farmacéutica

• 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 (ask your doctor),
• if you are pregnant, or might be pregnant because you are not using reliable contraceptive methods. Please read the information in the sections “Contraceptives” and “Other medicines and Bosentan Sandoz Farmacéutica”,
• if you are taking cyclosporine A (a medicine used after organ transplant or to treat psoriasis).

If you have any of these conditions, inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Bosentan Sandoz Farmacéutica.

Tests your doctor will perform before prescribing treatment

• a blood test to assess liver function,
• a blood test to check for anemia (low hemoglobin),
• a pregnancy test if you are a woman of childbearing potential.

Abnormal liver function tests and anemia have been observed in some patients taking bosentan.

Blood tests your doctor will perform during treatment

During treatment with bosentan, your doctor will schedule regular blood tests to monitor changes in your liver function and hemoglobin levels.

For all these tests, please refer to the Patient Alert Card (included inside the Bosentan Sandoz Farmacéutica tablet pack). It is important that you have regular blood tests while taking bosentan. We recommend that you write down the date of your most recent test and your next scheduled test (ask your doctor for the date) on the Patient Alert Card to help you remember when your next visit is due.

Blood tests for liver function

These tests must be performed monthly throughout the entire duration of bosentan treatment. After any dose increase, an additional test must be performed 2 weeks later.

Blood tests for anemia

These tests will be performed monthly during the first 4 months of treatment and then every 3 months, as patients taking bosentan may develop anemia.

If these tests show abnormal results, your doctor may decide to reduce the dose or stop bosentan treatment and carry out additional tests to investigate the cause.

Children and adolescents

Bosentan is not recommended in pediatric patients with systemic sclerosis and active digital ulceration. Bosentan should not be used in children with a body weight below 31 kg and pulmonary arterial hypertension. See section 3 “How to take Bosentan Sandoz Farmacéutica”.

Bosentan Sandoz Farmacéutica with food and drink

Bosentan Sandoz Farmacéutica can be taken with or without food.

Other medicines and Bosentan Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are taking:

• cyclosporine A (a medicine used after transplants and for the treatment of psoriasis), which must not be taken together with bosentan,
• sirolimus or tacrolimus, which are medicines used after transplants and are not recommended to be taken with bosentan,
• glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), fluconazole (a medicine for fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (a medicine for HIV), as it is not recommended to take these medicines with bosentan,
• other medicines for the treatment of HIV infection, which may require special monitoring when taken with bosentan,
• hormonal contraceptives, which are not effective as the sole method of contraception when taking bosentan. Inside the bosentan package, you will find a Patient Alert Card that you must read carefully. Your doctor and/or gynecologist will determine the appropriate contraceptive method for you,
• other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil,
• warfarin (an anticoagulant),
• simvastatin (used for the treatment of hypercholesterolemia).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Women of childbearing potential

DO NOT take bosentan if you are pregnant or planning to become pregnant.

Pregnancy tests

Bosentan may harm unborn children conceived before or during treatment. If you are a woman of childbearing potential, your doctor will require you to take a pregnancy test before starting bosentan treatment and regularly while taking bosentan.

Contraception

If you could become pregnant, you must use a reliable method of contraception (contraception) while taking bosentan. Your doctor or gynecologist will advise you on reliable contraceptive methods while taking bosentan. Since bosentan may reduce the effectiveness of hormonal contraception (e.g., oral, injection, implant, or transdermal 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 condom). Inside the bosentan tablet pack, you will find the Patient Alert Card. You must complete this card and bring it to your doctor at your next visit so that your doctor or gynecologist can determine whether you need an alternative or additional reliable contraceptive method. A monthly pregnancy test is recommended while taking bosentan if you are of childbearing age.

Inform your doctor immediately if you become pregnant while taking bosentan or plan to become pregnant in the near future.

Breastfeeding

Bosentan passes into breast milk. You are advised to stop breastfeeding if you are prescribed bosentan, as it is unknown whether bosentan in breast milk may harm your baby. Discuss this with your doctor.

Fertility

If you are a man taking bosentan, this medicine may reduce your sperm count. It cannot be ruled out that it may affect your potential to father a child. Talk to your doctor if you have any questions or concerns about this.

Driving and use of machines

Bosentan has no influence or negligible influence on the ability to drive and use machines. However, bosentan may cause hypotension (low blood pressure), which can lead to dizziness, blurred vision, and may affect your ability to drive or operate machinery. Therefore, if you feel dizzy or experience blurred vision while taking bosentan, do not drive or operate tools or machinery.

Bosentan Sandoz Farmacéutica contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; that is, essentially “sodium-free”.

3. How to take Bosentan Sandoz Farmacéutica

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment with bosentan should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension (PAH) or systemic sclerosis.

Recommended dose

Adults

Treatment in adults is usually started at 62.5 mg twice daily (morning and night) for the first 4 weeks. After this period, your doctor will usually advise you to take one 125 mg tablet twice daily, depending on your response to bosentan.

Use in children and adolescents

The recommended dose in children is indicated only for PAH. For children aged 1 year and older, treatment with bosentan is usually initiated at 2 mg per kg of body weight twice daily (morning and night). However, certain bosentan doses cannot be administered to children with body weight below 31 kg. For these patients, a bosentan tablet with a lower dose is required. Your doctor will advise you regarding the appropriate dose.

If you feel that the effect of bosentan is too strong or too weak, consult your doctor to determine whether a dose adjustment is needed.

How to take Bosentan Sandoz Farmacéutica

The tablets should be taken twice daily (morning and night) with water. The tablets may be taken with or without food.

If you take more Bosentan Sandoz Farmacéutica than you should

If you have taken more Bosentan Sandoz Farmacéutica than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medication and amount taken.

If you forget to take Bosentan Sandoz Farmacéutica

If you forget to take bosentan, take the missed dose as soon as you remember, and then continue taking it according to your usual schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Bosentan Sandoz Farmacéutica

If you suddenly stop treatment with bosentan, your symptoms may worsen. Do not stop taking bosentan unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most serious adverse effects with bosentan are:

• Abnormal liver function, which may affect more than 1 in 10 people.
• Anaemia (reduced blood count), which may affect up to 1 in 10 people. Anaemia may occasionally require blood transfusion.

Your liver and blood values will be tested during treatment with bosentan (see section 2). It is important that you have these tests performed as prescribed by your doctor.

Signs that your liver may not be working properly include:

• nausea (feeling sick),
• vomiting,
• fever (high temperature),
• stomach (abdominal) 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 syndrome (joint and muscle pain with fever).

If you experience any of these symptoms**, consult your doctor immediately**

Other adverse effects:

Very common (may affect more than 1 in 10 people):

• headache,
• oedema (swelling of legs and ankles or other signs of fluid retention).

Common (may affect up to 1 in 10 people):

• flushing (redness of the skin),
• hypersensitivity reactions (including skin inflammation, itching and skin rash),
• gastro-oesophageal reflux (acid reflux),
• diarrhoea,
• syncope (fainting),
• palpitations (fast or irregular heartbeats),
• low blood pressure,
• nasal congestion.

Uncommon (may affect up to 1 in 100 people):

• thrombocytopenia (decreased number of platelets in the blood),
• neutropenia/leucopenia (decreased number of white blood cells in the blood),
• elevated liver function tests with hepatitis (liver inflammation), including possible worsening of underlying hepatitis and/or jaundice (yellowing of the skin or whites of the eyes).

Rare (may affect up to 1 in 1000 people):

• anaphylaxis (generalised allergic reaction), angioedema (swelling, more frequently around the eyes, lips, tongue or throat),
• liver cirrhosis (fibrosis), liver failure (severe impairment of liver function), autoimmune hepatitis (liver inflammation caused by the body's own immune system attacking liver cells), which may occur even several months to years after starting treatment.

Cases of blurred vision have also been reported with unknown frequency (cannot be estimated from available data).

Adverse effects in children and adolescents

The adverse effects observed in children treated with bosentan are the same as those in adults.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bosentan Sandoz Farmacéutica

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

Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Medicines and packaging that are no longer needed should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bosentan Sandoz Farmacéutica

Bosentan Sandoz Farmacéutica 62.5 mg film-coated tablets:

• The active substance is bosentan (as monohydrate).

Each film-coated tablet contains 62.5 mg of bosentan (equivalent to 64.541 mg of bosentan monohydrate).

• Other components (excipients):

Tablet core: maize starch, pregelatinized maize starch, sodium carboxymethyl potato starch (type A), povidone K 30, poloxamer 188, colloidal anhydrous silica, glyceryl dibehenate, and magnesium stearate.

Coating: Opadry Orange 21K23007 (contains hypromellose, titanium dioxide (E171), ethylcellulose, triacetin (E 1518), talc (E 553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172)).

Bosentan Sandoz Farmacéutica 125 mg film-coated tablets:

• The active substance is bosentan (as monohydrate).

Each film-coated tablet contains 125 mg of bosentan (equivalent to 129.082 mg of bosentan monohydrate).

• Other components (excipients):

Tablet core: maize starch, pregelatinized maize starch, sodium carboxymethyl potato starch (type A), povidone K 30, poloxamer 188, colloidal anhydrous silica, glyceryl dibehenate, and magnesium stearate.

Coating: Opadry Orange 21K23007 (contains hypromellose, titanium dioxide (E171), ethylcellulose, triacetin (E 1518), talc (E 553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172)).

Appearance of the product and contents of the pack

Bosentan Sandoz Farmacéutica 62.5 mg are light orange, round, biconvex film-coated tablets, 6 mm in diameter.

Bosentan Sandoz Farmacéutica 125 mg are light orange, oval, biconvex film-coated tablets, 11x5 mm in size.

The film-coated tablets are packaged in PVC/PVDC-Aluminum blisters inside a cardboard box.

Pack sizes:

14, 56 or 112 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57,

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Bosentan Sandoz 125 mg - Filmtabletten

Belgium: Bosentan Sandoz 62.5 mg filmomhulde tabletten

Bosentan Sandoz 125 mg filmomhulde tabletten

Bulgaria: Bosentan SDZ 125 mg ????????? ????????

Germany: Bosentan HEXAL 62.5 mg Filmtabletten

Bosentan HEXAL 125 mg Filmtabletten

Netherlands: Bosentan Sandoz 62.5 mg, filmomhulde tabletten

Bosentan Sandoz 125 mg, filmomhulde tabletten

Norway: Bosentan Sandoz 62.5 mg, tablett, filmdrasjert

Bosentan Sandoz 125 mg, tablett, filmdrasjert

Poland: Bosentan Sandoz GmbH, 125 mg, tabletki powlekane

Portugal: Bosentano Sandoz 62.5 mg Comprimido revestido por película

Bosentano Sandoz 125 mg Comprimido revestido por película

Sweden: Bosentan Sandoz 62.5 mg filmdragerade tabletter

Bosentan Sandoz 125 mg filmdragerade tabletter

Date of the most recent revision of this summary: December 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

Patient alert card

((Cover))
	Important Safety Alerts for Patients Treated with Bosentan Sandoz Farmacéutica
This card contains important information about Bosentan Sandoz Farmacéutica. Please read this card carefully before starting your treatment with Bosentan Sandoz Farmacéutica.
Your name: ____________________________________________________ Prescribing physician: ______________________________________________ If you have any questions about Bosentan Sandoz Farmacéutica, ask your doctor.
Sandoz Farmacéutica, S.A.
((Inside 1))
If you are a woman of childbearing potential, please read this page carefully
Pregnancy
Bosentan Sandoz Farmacéutica can harm fetal development. Therefore, you must not take Bosentan Sandoz Farmacéutica if you are pregnant, and you must not become pregnant while taking Bosentan Sandoz Farmacéutica.
Additionally, if you have pulmonary hypertension, you should know that pregnancy can severely worsen the symptoms of your disease. If you suspect you might be pregnant, inform your doctor or gynecologist immediately.
Contraception
Hormonal contraceptive methods such as oral contraceptives, hormone injections, implants, or transdermal patches do not reliably prevent pregnancy in women being treated with Bosentan Sandoz Farmacéutica. To prevent pregnancy, you must use a barrier method—such as a condom, diaphragm, or vaginal sponge—along with any available hormonal contraceptive method. Be sure to discuss any concerns with your doctor or gynecologist—complete the questionnaire included on the back of this card and give it to your doctor or gynecologist at your next visit.
You must have a pregnancy test before starting treatment with Bosentan Sandoz Farmacéutica and every month throughout the duration of treatment, even if you believe you are not pregnant. Date of first monthly pregnancy test: ____________________________________
((Back cover)) Contraception
Do you use or take contraceptives? ? Yes ? No
If yes, write the names here: ______________________________ ______________________________ Give this card to your doctor or gynecologist at your next visit, and they will advise you whether you need additional or alternative contraceptive methods.
((Inside 2)) Blood tests to monitor liver function
Abnormalities in blood tests of liver function have been detected in some patients taking Bosentan Sandoz Farmacéutica. During treatment with Bosentan Sandoz Farmacéutica, your doctor will schedule regular blood tests to monitor any changes in your liver function.
Remember that you must have a blood test to monitor your liver function every month. After a dose increase, an additional test will be performed 2 weeks later.
Date of first monthly test: --------------------------------------- Monthly schedule for blood tests to monitor liver function: