Bosentan Kern Pharma 62.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bosentan Kern Pharma 62.5 mg film-coated tablets EFG

Bosentan Kern Pharma 125 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, because 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 Kern Pharma is and what it is used for
2. What you need to know before taking Bosentan Kern Pharma
3. How to take Bosentan Kern Pharma
4. Possible side effects
5. How to store Bosentan Kern Pharma
6. Contents of the pack and other information

1. What Bosentan Kern Pharma is and what it is used for

Bosentan Kern Pharma contains bosentan, which blocks the natural hormone called endothelin-1 (ET-1), and causes narrowing of blood vessels. Bosentan therefore causes dilation of blood vessels. It belongs to a class of medicines known as “endothelin receptor antagonists”.

Bosentan 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 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 alleviates 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 in physical activity. Some improvements have been observed in patients with PAH class II. ‘Class II’ indicates slight limitation in physical activity.

The PAH for which bosentan is indicated may be:

• idiopathic (in which no cause is identified, or 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 at birth) with shunts (abnormal connections) that cause abnormal blood flow between the heart and the lungs.

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

2. What you need to know before starting Bosentan Kern Pharma

Do not take Bosentan Kern Pharma

• 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 become pregnant because you are not using reliable contraceptive methods. Please read the information in the sections “Contraception” and “Other medicines and Bosentan Kern Pharma”
• 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

Tests your doctor will perform before prescribing treatment

• a blood test to assess liver function
• a blood test to detect 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 box of bosentan tablets). It is important that you undergo regular blood tests while taking this medicine. We recommend that you write 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.

Liver function blood tests

These tests must be performed monthly throughout the entire duration of bosentan treatment. After a 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 are abnormal, your doctor may decide to reduce the dose or discontinue treatment with bosentan 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. See also section 3. How to take Bosentan Kern Pharma.

Other medicines and Bosentan Kern Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those not prescribed. It is especially important that you inform your doctor if you are taking:

• cyclosporine A (a medicine used after organ transplantation and to treat psoriasis), which must not be taken together with bosentan.
• sirolimus or tacrolimus, medicines used after organ transplantation, which are not recommended to be taken together with bosentan.
• glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), fluconazole and ketoconazole (medicines for fungal infections), or nevirapine (a medicine for HIV), as it is not recommended to take these medicines together with bosentan.
• other medicines for the treatment of HIV infection, which when taken together with bosentan may require special monitoring.
• oral contraceptives, which are not effective as the sole method of contraception when taking bosentan. Inside the packaging of this medicine 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 to treat hypercholesterolemia).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 this medicine.

Contraception

If you could become pregnant, use a reliable method of contraception (birth control) while taking bosentan. Your doctor or gynecologist will advise you on reliable contraceptive methods while taking this medicine. Since bosentan may reduce the effectiveness of hormonal contraception (e.g., oral, injection, implant, or skin 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 box of this medicine, 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

Inform your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if you are prescribed bosentan, as it is not known whether this medicine passes into breast milk.

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 fatherhood. Talk to your doctor if you have any questions or concerns about this.

Driving and use of machines

Bosentan has no influence or only a negligible influence on driving and operating machinery. However, this medicine may cause hypotension (low blood pressure), which can lead to dizziness, blurred vision, and may impair 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 Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Bosentan Kern Pharma

Treatment with bosentan should only be initiated and monitored by a physician experienced in the treatment of PAH or systemic sclerosis. Always follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Taking Bosentan Kern Pharma with food and drink

This medicine may be taken with or without food.

Recommended dose

Adults

Treatment in adults usually starts with 62.5 mg twice daily (morning and evening) for the first 4 weeks. After this, your doctor will usually advise you to increase to 125 mg twice daily, depending on your response to bosentan.

Children and adolescents

The recommended dose in children is only for PAH. For children aged 1 year and older, treatment with bosentan usually starts at 2 mg per kg of body weight twice daily (morning and evening). Your doctor will advise you on the appropriate dose.

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

How to take Bosentan Kern Pharma

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

If you take more Bosentan Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bosentan Kern Pharma

If you forget to take your dose, take it as soon as you remember, and then continue taking the medicine at your usual times. Do not take a double dose to make up for a missed dose.

If you stop taking Bosentan Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Bosentan Kern Pharma 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 levels), which may affect more than 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 performed as prescribed by your doctor.

Signs that your liver may not be functioning properly include:

• Nausea (feeling the need to vomit)
• Vomiting
• Fever (elevated temperature)
• Stomach (abdominal) pain
• Jaundice (yellowing of the skin or whites of the eyes)
• Dark-coloured 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 the 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 (rapid 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 1,000 people):

• Anaphylaxis (generalised allergic reaction), angioedema (swelling, most 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

Adverse effects in children and adolescents

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

Cases of blurred vision have also been reported, with frequency not known (cannot be estimated from the available data).

Reporting of adverse effects

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

5. Storage of Bosentan Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Bosentan Kern Pharma

• Bosentan Kern Pharma 62.5 mg: The active substance is bosentan. Each tablet contains 62.5 mg of bosentan (as monohydrate).

• Bosentan Kern Pharma 125 mg: The active substance is bosentan. Each tablet contains 125 mg of bosentan (as monohydrate).
  The other components are pregelatinized corn starch, povidone, sodium carboxymethyl starch type A (from potato), magnesium stearate and Opadry orange 03K93638 (a mixture consisting of hypromellose, iron oxide red (E-172), iron oxide yellow (E-172), titanium dioxide (E-171) and triacetin).

Appearance of the product and contents of the pack

Bosentan Kern Pharma 62.5 mg: round, orange-white, film-coated tablets.

PVC/PCTFE/Aluminium blisters containing 56 tablets.

Bosentan Kern Pharma 125 mg: oval, orange-white, film-coated tablets.

PVC/PCTFE/Aluminium blisters containing 56 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: September 2025

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