Prospect: Information for the User

Bosentan Aurovitas 125 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must 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 not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Bosentan Aurovitas

3.How to take Bosentan Aurovitas

4.Possible adverse effects

5.Storage of Bosentan Aurovitas

6.Contents of the package and additional information

The Bosentan Aurovitas tablets contain bosentan, which blocks a natural hormone called endothelin-1 (ET-1) and causes narrowing of blood vessels. Therefore, bosentan produces dilation of blood vessels and belongs to the class of medications known as "endothelin receptor antagonists".

Bosentan is used to treat:

?Pulmonary arterial hypertension(PAH): PAH is a severe narrowing of the blood vessels in the lungs resulting in an increase in 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 reach 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 of physical activity. Some improvements have been observed in patients with PAH class II. The "class II" implies slight limitation of physical activity. The PAH for which bosentan is indicated may be:

?primary (in which the cause or hereditary is not identified);

?caused by scleroderma (also known as systemic sclerosis, a disease in which there is abnormal growth of connective tissue that forms the support of the skin and other organs);

?caused by congenital heart defects (birth defects) with shunts (abnormal communications) that cause abnormal blood flow between the heart and lungs.

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

Do not take Bosentan Aurovitas

-if you are allergic to bosentanor 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 pregnantas you are not using reliable contraceptive methods. Read the information in the section “Contraceptives” and “Other medicines andBosentan Aurovitas”.

-if you are taking ciclosporin A(a medicine used after a transplant or to treat psoriasis).

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

Warnings and precautions

Consult your doctor orpharmacist before starting to takeBosentanAurovitas.

Tests your doctor will do before starting treatment

-a blood test to check liver function.

-a blood test to check for anemia (low hemoglobin).

-a pregnancy test, if you are a fertile woman.

Abnormalities in liver function tests and anemia have been found in some patients taking bosentan.

Tests your doctor will do during treatment

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

For all these tests, see also the Patient Alert Card (inside the Bosentan Aurovitas packaging). It is essential to have these blood tests regularly while taking bosentan. We recommend that you write the date of the most recent test and also the date of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next appointment is.

Liver function blood test

These tests must be done monthly throughout the duration of treatment with bosentan. After a dose increase, an additional test must be done after 2 weeks.

Anemia blood test

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

If these tests show abnormalities, your doctor may decide to reduce the dose or stop treatment with bosentan and perform additional tests to investigate the cause.

Children and adolescents

Bosentan is not recommended for 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 taken recently, or may need to take any other medicine, including those purchased without a prescription. It is especially important to inform your doctor if you are taking:

-ciclosporin A (a medicine administered after transplants and to treat psoriasis) which should not be administered with bosentan.

-sirolimus or tacrolimus, which are medicines administered after transplants, and it is not recommended to administer them with bosentan.

-glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (an antifungal medicine), ketoconazole (a medicine used to treat Cushing's syndrome) or nevirapine (an HIV medicine), as it is not recommended to administer these medicines with bosentan.

-other HIV infection treatment medicines, which administered with bosentan may require special monitoring.

-oral contraceptives, which are not effective as a single method of contraception when taking bosentan. 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 suitable contraceptive method for you.

-other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil.

-warfarin (an anticoagulant).

-simvastatin (used to treat hypercholesterolemia).

Taking Bosentan Aurovitas with food, drinks, and alcohol

Bosentan can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Fertile women

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

Pregnancy tests

Bosentan may affect unborn babies conceived before or during treatment. If you are a fertile woman, your doctor will ask you to have a pregnancy test before starting treatment with bosentan, and regularly while taking it.

Contraceptives

If you may become pregnant, use a reliable contraceptive method (contraception) while taking bosentan. Your doctor or gynecologist will advise you on suitable contraceptive methods while taking bosentan. Since bosentan may make hormonal contraception ineffective (e.g., oral, injection, implant, or skin patch), this method alone is not reliable. Therefore, if you use hormonal contraceptives, you must also use a barrier method (e.g., female condom, diaphragm, spermicide, or your partner must also use a condom). Inside the Bosentan Aurovitas packaging, you will find a Patient Alert Card that you must complete and bring to your doctor's next visit so that your doctor or gynecologist can determine if you need an alternative or additional reliable contraceptive method. It is recommended to have a pregnancy test monthly while taking bosentan and are fertile.

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. It is recommended to stop breastfeeding if you are prescribed bosentan, as it is unknown if the presence of bosentan in breast milk may harm your baby. Talk to your doctor about it.

Fertility

If you are a man taking bosentan, it is possible that this medicine may decrease 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 doubts or concerns about it.

Driving and using machines

The influence of bosentan on the ability to drive and use machines is negligible or insignificant. However,bosentanmay cause hypotension (low blood pressure) that may cause dizziness, affect your vision, and affect your ability to drive and use machines. Therefore, if you feel dizzy or see blurry while takingbosentan, 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; it is essentially “sodium-free”.

The treatment with bosentan should only be initiated and controlled by a doctor who has experience in the treatment of HAP or systemic sclerosis. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

The treatment in adults is usually started with 62.5 mg twice a day (morning and night) for the first 4 weeks; afterwards, your doctor will normally advise you to take one 125 mg tablet twice a day, depending on how you react to bosentan.

Children and adolescents

The recommended dose in children is only for HAP. For children from 1 year of age, the treatment with bosentan is usually started with 2 mg per kg of body weight twice a day (morning and night). Your doctor will advise you about the dose.

Remember that there are other bosentan formulations available, which may facilitate dosing in children and patients with low weight or difficulties swallowing coated tablets.

If you feel that the effect of this medication is too strong or too weak, consult with your doctor to verify if you need a dose adjustment.

How to take Bosentan Aurovitas Bosentan Aurovitas

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

If you take more Bosentan Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bosentan Aurovitas

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

If you interrupt the treatment with Bosentan Aurovitas

If you interrupt the treatment with bosentan, your symptoms may worsen. Do not stop taking bosentan unless your doctor tells you to. Your doctor may indicate that you reduce the dose for a few days before stopping it completely.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

The most serious side effects with bosentan are:

-Abnormal liver function, which can affect more than 1 in 10 people.

-Anemia (decreased blood count), which can affect more than 1 in 10 people. Anemia may occasionally require blood transfusions.

Your liver and blood values will be monitored during treatment with bosentan (see section 2). It is essential that these analyses are done as prescribed by your doctor.

The signs that your liver may not be functioning correctly include:

-Nausea (need to vomit).

-Vomiting.

-Fever (elevated temperature).

-Abdominal pain.

-Jaundice (yellowish discoloration of the skin or white of the eyes).

-Dark-colored urine.

-Itching.

-Fatigue or lethargy (unusual tiredness or exhaustion).

-Pseudogripal syndrome (joint and muscle pain with fever).

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

Other side effects:

Very common(may affectmore than 1 in 10people):

-Headache.

-Edema (swelling of the legs and ankles or other signs of fluid retention).

Common(may affectup to 1 in 10people):

-Redness of the skin.

-Hypersensitivity reactions (including skin inflammation, itching, and skin rash).

-Gastroesophageal reflux (acid reflux).

-Diarrea.

-Syncope (fainting).

-Palpitations (rapid or irregular heartbeats).

-Low blood pressure.

-Conjunctivitis (nasal congestion).

Uncommon(may affectup to 1 in 100people):

-Thrombocytopenia (decreased platelet count in the blood).

-Neutropenia/leucopenia (decreased white blood cell count).

-Elevated liver function tests with hepatitis (inflammation of the liver), including a possible exacerbation of hepatitis and/or jaundice (yellowish discoloration of the skin or white of the eyes).

Rare(may affectup to 1 in 1,000people):

-Anaphylaxis (generalized allergic reaction), angioedema (swelling, often around the eyes, lips, tongue, or throat).

-Cirrhosis (fibrosis) of the liver, liver failure (severe alteration of liver function).

Blurred vision has also been reported with unknown frequency (the frequency cannot be estimated from the available data).

Side effects in children and adolescents

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bosentan Aurovitas

-The active ingredient is bosentan (as monohydrate). Each film-coated tablet contains 125 mg of bosentan (as monohydrate).

-The other components are:

Core tablet:pregelatinized cornstarch, cornstarch, sodium carboxymethylcellulose (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 product and contents of the package

Film-coated tablets of orange-white color, oval, biconvex, with the mark “K” on one side and “22” on the other, separated by a groove. The tablet can be divided into equal doses. The size is 11.2 mm × 5.2 mm.

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

Packaging sizes:

In blister pack: 14, 28, 30, 50, 56, 60, 90, 98, 112, and 120 film-coated tablets.

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).