Bosentan Sun 62.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bosentan SUN 62.5 mg film-coated tablets EFG

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 you should not give it 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 they are adverse effects not listed in this leaflet.

Contents of the leaflet

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

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

Bosentan SUN tablets contain bosentan, which blocks a natural hormone called endothelin-1 (ET-1) that causes narrowing of the blood vessels. Bosentan therefore causes dilation of the blood vessels and belongs to a class of medicines known as "endothelin receptor antagonists".

Bosentan SUN 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 SUN is used for the treatment of patients with PAH 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 been observed in patients with PAH class II. 'Class II' indicates slight limitation of physical activity. The PAH for which Bosentan SUN 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 at birth) with shunts

(abnormal communications) causing abnormal blood flow between the heart and lungs.

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

2. What you need to know before taking Bosentan SUN

Do not take Bosentan SUN:

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

Tests your doctor will perform before starting treatment

• a blood test to assess liver function
• a blood test to detect anaemia (low haemoglobin)
• a pregnancy test if you are a woman of childbearing potential

Abnormal liver function tests and anaemia (low haemoglobin) have been observed in some patients taking Bosentan.

Blood tests your doctor will perform during treatment

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

For all these tests, please refer to the Patient Alert Card (included in the Bosentan SUN tablet pack). It is important that you have regular blood tests while taking Bosentan SUN. 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 treatment with Bosentan SUN. After a dose increase, an additional test should be performed 2 weeks later.

Blood tests for anaemia

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

If these tests are abnormal, your doctor may decide to reduce the dose or discontinue treatment with Bosentan SUN and perform additional tests to investigate the cause.

Children and adolescents

Bosentan SUN is not recommended in paediatric patients with systemic sclerosis and active digital ulceration. See also section 3. How to take Bosentan SUN.

Taking Bosentan SUN with other medicines

Inform 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 medicine used after transplantation and to treat psoriasis), which must not be taken together with Bosentan SUN.
• sirolimus or tacrolimus, medicines used after transplantation, which are not recommended to be taken together with Bosentan SUN.

•?glibenclamide (a medicine for diabetes), rifampicin (a medicine for tuberculosis), or fluconazole (an antifungal medicine), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as it is not recommended to take these medicines together with Bosentan SUN.

• other medicines for the treatment of HIV infection, which may require special monitoring when taken with Bosentan SUN.
• oral contraceptives, which are not effective as the sole method of contraception when taking Bosentan SUN. Inside the Bosentan SUN package, you will find a Patient Alert 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

Women of childbearing potential

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

Pregnancy tests

Bosentan SUN 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 treatment with bosentan, and regularly while taking bosentan.

Contraception

If you could become pregnant, use a reliable method of contraception (contraception) while taking Bosentan SUN. Your doctor or gynaecologist will advise you on reliable contraceptive methods while taking Bosentan SUN. Since Bosentan SUN 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 male condom). Inside the Bosentan SUN 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 gynaecologist can determine whether you need an alternative or additional reliable contraceptive method. A monthly pregnancy test is recommended while taking Bosentan SUN if you are of childbearing age.

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

Breast-feeding

Bosentan passes into breast milk. You are advised to stop breast-feeding if you are prescribed Bosentan SUN, as it is unknown whether this medicine could harm your baby. Inform your doctor about this.

Fertility

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

Driving and using machines

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

Bosentan SUN contains sodium

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

3. How to take Bosentan SUN

Treatment with Bosentan SUN 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.

Bosentan SUN with food and drink

Bosentan SUN may be taken with or without food.

Recommended dose:

Adults

Treatment in adults is usually started at 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 your response to Bosentan SUN.

Children and adolescents

The recommended dose in children is indicated only for PAH. For children aged 1 year and older, treatment with Bosentan SUN is usually initiated at 2 mg per kg of body weight twice daily (morning and evening). However, certain bosentan doses are not available for children weighing less than 31 kg. For these patients, a bosentan tablet with a lower dose is required. Your doctor will advise you on the appropriate dose.

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

How to take Bosentan SUN

Bosentan SUN 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 SUN than you should

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

If you forget to take Bosentan SUN

If you forget to take Bosentan SUN, take the missed dose as soon as you remember, 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 SUN

If you suddenly stop treatment with Bosentan SUN, your symptoms may worsen. Do not stop taking Bosentan SUN 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 SUN are:

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

Your liver and blood values will be tested during treatment with Bosentan SUN (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 (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)
• Pseudo-flu 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 (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 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 (serious impairment of liver function)

Frequency unknown (cannot be estimated from the available data):

• Blurred vision

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, 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: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bosentan SUN

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 the month indicated.

Validity period after first opening (for the bottle only): 50 days

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

6. Contents of the pack and other information

Composition of Bosentan SUN 62.5 mg film-coated tablets

• The active substance is bosentan. Each tablet contains 62.5 mg of bosentan.
• The other components are corn starch, pregelatinized corn starch, sodium glycolate starch from potato, povidone K-30, glyceryl behenate, magnesium stearate.

The film coating (Opadry yellow 21K520019) contains: hypromellose (E464), titanium dioxide (E171), triacetin, talc (E553b), ethylcellulose, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

Bosentan SUN 62.5 mg: film-coated tablets, round, peach or light peach in colour, biconvex, marked with "62.5" on one side and smooth on the other. The tablets have a diameter of approximately 5.9 mm.

PVC/PE/PVdC/Al blisters containing 14 and 56 film-coated tablets.

Single-dose perforated PVC/PE/PVdC/Al blisters containing 14 x 1 and 56 x 1 film-coated tablets.

HDPE bottles containing 56 and 100 film-coated tablets.

The HDPE bottles are made of white, opaque high-density polyethylene, with an induction seal and child-resistant cap, and include a silica gel desiccant sachet. THE CONTENTS OF THE SACHET MUST NOT BE INGESTED.

Only certain pack sizes may be marketed.

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

DE: BOSENTAN SUN 62,5 mg Filmtabletten
FR: BOSENTAN SUN 62,5 mg, comprimé pelliculé
IT: Bosentan Sun
ES: Bosentan SUN 62,5 mg comprimidos recubiertos con película EFG
RO: Bosentan Terapia 62,5 mg comprimate filmate
PL: Bosentan Ranbaxy 62,5 mg

Marketing Authorisation Holder:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
Hoofddorp - 2132JH
The Netherlands

Manufacturer responsible:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
Hoofddorp - 2132JH
The Netherlands

ALKALOIDA Chemical Company Zrt.
Kabay János u. 29
Tiszavasvári - H-4440
Hungary

Terapia SA
Str. Fabricii nr. 124
Cluj Napoca – 400632
Romania

Local representative:

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 Barcelona
Spain
Tel: +34 93 342 78 90

Date of the most recent revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios): http://www.aemps.gob.es/.