Bosentan Normon 125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bosentan Normon 125 mg film-coated tablets EFG

bosentan

Read all of this 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 must not be given to other people, 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 such effects are not listed in this leaflet.

What is in this leaflet

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

1. What Bosentan Normon is and what it is used for

Bosentan Normon tablets contain bosentan, which blocks a natural hormone called endothelin-1 (ET-1) that causes narrowing of blood vessels. Bosentan therefore causes dilation of blood vessels and 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' implies marked limitation in physical activity. Some improvements have been observed in patients with PAH class II. 'Class II' implies 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 characterized by abnormal growth of connective tissue that supports the skin and other organs),
• caused by congenital heart defects (present from birth) with shunts (abnormal connections) causing 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 Normon reduces the number of new ulcers (in hands and feet) that develop.

2. What you need to know before taking Bosentan Normon

Do not take Bosentan Normon:

• 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 could be pregnant due to not using reliable contraceptive methods. Please read the information in the sections “Contraception” and “Other medicines and Bosentan Normon”.
• if you are taking cyclosporine A (a medicine used after transplantation 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 Normon.

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.

Abnormalities in liver function tests and anemia have been observed in some patients taking Bosentan Normon.

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 in the Bosentan Normon 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.

Liver function blood tests

These tests must be performed monthly throughout the entire duration of bosentan treatment. After a dose increase, an additional test should 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 thereafter, as patients taking bosentan may develop anemia.

If these tests show abnormal results, your doctor may decide to reduce the dose or discontinue treatment with Bosentan Normon and perform 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 Normon.

Other medicines and Bosentan Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. It is especially important that you inform your doctor if you are taking:

• cyclosporine A (a medicine used after transplantation and to treat psoriasis), which must not be taken together with bosentan.
• sirolimus or tacrolimus, which are medicines used after transplantation, and are not recommended to be taken together with bosentan.
• glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), fluconazole (an antifungal medicine), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be taken together with bosentan.
• other medicines for HIV infection, which when taken together with bosentan may require special monitoring.
• oral contraceptives, which are not effective as the sole contraceptive method when taking bosentan. Inside the Bosentan Normon 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 pulmonary hypertension: sildenafil and tadalafil.
• warfarin (an anticoagulant).
• simvastatin (used to treat hypercholesterolemia).

Pregnancy, breastfeeding, and fertility

Women of childbearing potential

DO NOT take Bosentan Normon 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 have a pregnancy test before starting bosentan treatment, and regularly while taking bosentan.

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 bosentan. 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 Bosentan Normon 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. Monthly pregnancy testing is recommended while taking bosentan if you are of childbearing potential.

Inform your doctor immediately if you become pregnant while taking bosentan, or if you 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 unknown whether this medicine passes into breast milk.

Fertility

If you are a man taking bosentan, this medicine may reduce your sperm count. A possible effect on fertility cannot be ruled out. 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 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 Normon 125 mg film-coated tablets EFG contains sodium

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

3. How to take Bosentan Normon

Treatment with Bosentan Normon should only be initiated and monitored by a physician experienced in the treatment of PAH or systemic sclerosis. Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Use of Bosentan Normon with food and drink

Bosentan Normon 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 take one 125 mg tablet twice daily, depending on how you respond 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 bosentan is too strong or too weak, consult your doctor to determine whether a dose adjustment is needed.

How to take Bosentan Normon

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

If you take more Bosentan Normon than you should

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

If you forget to take Bosentan Normon

If you forget to take Bosentan Normon, 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 Normon

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 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 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 sick).
• Vomiting.
• Fever (high 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).
• Pseudoflu 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 (reddening of the skin).
• Hypersensitivity reactions (including skin inflammation, itching, and skin rash).
• Gastro-oesophageal reflux (acid reflux).
• Diarrhoea.
• Syncope (fainting).
• Palpitations (rapid or irregular heartbeat).
• 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 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, 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 several months to years after starting treatment.

Cases of blurred vision have also been reported with unknown frequency (frequency cannot be estimated from the 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, pharmacist or nurse, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bosentan Normon

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 pack following "EXP.:". The expiry date refers to the last day of the indicated month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bosentan Normon 125 mg film-coated tablets

• The active substance is bosentan monohydrate. Each tablet contains 125 mg of bosentan (as monohydrate).

• The other components are: pregelatinized maize starch, sodium carboxymethyl potato starch type A, colloidal anhydrous silica, povidone, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Bosentan Normon 125 mg are elongated, biconvex, film-coated tablets of whitish-orange color.

Bosentan Normon 125 mg film-coated tablets are available in packs of 14, 56 or 112 tablets in aluminum/aluminum-polyamide-PVC or aluminum/PVDC-PE blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
C/ Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Bosentano Normon 125 mg coated tablets

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/