Bosentan Aurovitas 62.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bosentan Aurovitas 62.5 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 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. See section 4.

Leaflet contents:

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

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

Bosentan Aurovitas tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1) that causes narrowing of blood vessels. Therefore, bosentan produces 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 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:

? primary (where 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 communications) 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 reduces the number of new digital ulcers (in hands and feet) that develop.

2. What you need to know before taking Bosentan Aurovitas

Do not take Bosentan Aurovitas

• 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 (consult your doctor).
• if you are pregnant, or could be pregnant because you are not using reliable contraceptive methods. Read the information in the sections “Contraception” and “Other medicines and Bosentan Aurovitas”.
• if you are taking cyclosporine A (a medicine used after organ transplant or to treat psoriasis).

If any of the above applies to you, inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Bosentan Aurovitas.

Tests your doctor will perform before treatment

• a blood test to monitor 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.

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, also refer to the Patient Alert Card (included inside the Bosentan Aurovitas tablet packaging). It is important that you have these regular blood tests while taking bosentan. We recommend that you write down the date of your most recent test and the date of 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 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. See also section 3. How to take Bosentan Aurovitas.

Other medicines and Bosentan Aurovitas

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 to inform your doctor if you are taking:

• cyclosporine A (a medicine used after transplantation and for the treatment of psoriasis), which must not be taken together with bosentan.
• sirolimus or tacrolimus, medicines used after transplantation, which 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 co-administration with bosentan is not recommended.
• other medicines for HIV infection, which may require special monitoring when taken with bosentan.
• oral contraceptives, which are not effective as the sole method of contraception during bosentan treatment. Inside the Bosentan Aurovitas packaging, 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).

Taking Bosentan Aurovitas with food, drink and alcohol

Bosentan may be taken with or without food.

Pregnancy, breastfeeding and fertility

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 a pregnancy test before starting bosentan treatment and regularly during treatment.

Contraception

If there is any possibility 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 contraception, you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must use a condom). Inside the Bosentan Aurovitas tablet packaging, you will find the Patient Alert Card. You must complete this card and bring it to your doctor during your next visit so 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 plan to become pregnant in the near future.

Breastfeeding

Bosentan passes into breast milk. You are advised to discontinue 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 ability to father a child. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines

The effect of bosentan on the ability to drive and use machines is negligible or minor. However, bosentan 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 Aurovitas contains sodium

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

3. How to take Bosentan Aurovitas

Treatment with bosentan should only be initiated and monitored by a physician experienced in the treatment of PAH or systemic sclerosis. Always follow exactly the dosing instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults

Treatment in adults is usually started at 62.5 mg twice daily (morning and evening) for the first 4 weeks; thereafter, your doctor will usually advise you to increase to one 125 mg tablet twice daily, depending on your response to bosentan.

Children and adolescents

The recommended dose for children applies 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 evening). Your doctor will advise you on the appropriate dose.

Please remember that other formulations of bosentan are available, which may facilitate dosing in children, low-weight patients, or patients who have difficulty swallowing coated tablets.

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 Aurovitas

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

If you take more Bosentan Aurovitas 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, stating the medication and the amount ingested.

If you forget to take Bosentan Aurovitas

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

If you stop taking Bosentan Aurovitas

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 experiences 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 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 like vomiting).
• 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).
• Pseudoinfluenza 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 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 several months to years after starting treatment.

Blurred vision has also been reported with unknown frequency (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 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Bosentan Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the stated 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 the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to 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 Aurovitas

• The active substance is bosentan (as monohydrate). Each film-coated tablet contains 62.5 mg of bosentan (as monohydrate).
• The other components are:

Tablet core: pregelatinized corn starch, corn starch, sodium carboxymethyl starch (type A) (from potato), crospovidone (type B), povidone (K-90), glyceryl dibehenate, magnesium stearate.

Coating: hypromellose (E464), ethylcellulose, triacetin, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Orange-white, round (6.1 mm in diameter), biconvex, film-coated tablets marked with "K" on one side and "21" on the other.

Bosentan Aurovitas film-coated tablets are available in white opaque triple-layered PVC/PE/PVdC-Aluminum blister packs and in HDPE bottles with polypropylene caps.

Pack sizes:

Blister packs: 14, 28, 30, 50, 56, 60, 90, 98 and 112 film-coated tablets.

Bottles: 30, 100 and 1,000 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

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

Date of the most recent review of this leaflet: January 2026

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