Leaflet: information for the user

Bosentan Kern Pharma 62.5 mg film-coated tablets

Bosentan Kern Pharma 125 mg film-coated tablets

Read 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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. Storage of Bosentan Kern Pharma

6. Contents of the pack and additional information

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 the class of medications called “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 to treat 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 a marked limitation of physical activity. Some improvements have been observed in patients with PAH class II. The ‘class II’ implies a 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 systemic sclerosis (also known as scleroderma, 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 (at birth) with 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 with a disease called systemic sclerosis. Bosentan reduces the number of new digital ulcers (on hands and feet) that appear.

Do not take Bosentan Kern Pharma

-if you areallergic to bosentanor to any of the other ingredients of this medication (listed in section 6)

-if you have liver problems(ask your doctor)

-if you are pregnant, or could become pregnantwhile not using reliable contraceptive methods. Please read the information in the section “Contraceptives” and “Other Medications and Bosentan Kern Pharma”

-if you are taking ciclosporin A(a medication used after a 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 the treatment

• a blood test to assess liver function
• a blood test to detect 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 perform during treatment

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

Please refer to the Patient Alert Card (inside the bosentan packaging) for these tests. It is essential to perform regular blood tests while taking this medication. We recommend that you write the date of the most recent test and your next test date (ask your doctor for the date) on the Patient Alert Card to help you remember when your next visit is.

Liver function tests

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

Anemia tests

These tests will be performed 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 discontinue bosentan treatment 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 Kern Pharma.

Other Medications and Bosentan Kern Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. It is especially important to inform your doctor if you are taking:

• ciclosporin A (a medication used after transplants and to treat psoriasis), which should not be administered with bosentan.
• sirólimus or tacrólimus, which are medications used after transplants, and are not recommended to be administered with bosentan.
• glibenclamida (a medication for diabetes), rifampicina (a medication for tuberculosis), fluconazol and ketoconazol (medications for fungal infections), or nevirapina (a medication for HIV) as they are not recommended to be administered with bosentan.
• other medications for HIV treatment, which when administered 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 medication, you will find a Patient Alert Card that you must read carefully. Your doctor and/or gynecologist will establish an alternative or additional reliable contraceptive method for you.
• other medications for pulmonary hypertension: sildenafilo and tadalafilo.
• warfarina (an anticoagulant).
• simvastatina (used to treat hypercholesterolemia).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Fertile Women

DO NOT TAKE BOSENTAN IF YOU ARE PREGNANT OR PLANNING 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 undergo a pregnancy test before starting bosentan treatment and regularly while taking this medication.

Contraceptives

If you may become pregnant, use a reliable contraceptive method (contraception) while taking bosentan. Your doctor or gynecologist will advise you on reliable contraceptive methods while taking this medication. Since bosentan may make hormonal contraceptives ineffective (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, spermicide, or your partner must also use a condom). Inside the packaging of this medication, 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 perform 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

Inform your doctorimmediately if you arebreastfeeding. We recommend that you discontinue breastfeeding if you are prescribed bosentan, as it is not known if this medication passes into breast milk.

Fertility

If you are a man taking bosentan, it is possible that this medication may decrease your sperm count. It cannot be ruled out that it may affect your ability to father a child. Discuss any concerns or doubts with your doctor.

Driving and Operating Machinery

Bosentan has no influence or this is insignificant on driving and operating machinery. However, this medication may cause hypotension (low blood pressure) that may cause dizziness, affect your vision, and affect your ability to drive and operate machinery. Therefore, if you feel dizzy or see blurry while taking bosentan, do not drive or operate tools or machinery.

Bosentan Kern Pharma contains sodium

This medication 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 PAH 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.

Use of Bosentan Kern Pharma with food and beverages

This medication can be taken with or without food.

The recommended dose is

Adult

The treatment in adults usually starts with 62.5 mg twice a day (morning and night) for the first 4 weeks, after which 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 PAH. For children from 1 year of age, the treatment with bosentan usually starts with 2 mg per kg of body weight twice a day (morning and night). Your doctor will advise you on the dose.

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

How to Take Bosentan Kern Pharma

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

If you take more Bosentan Kern Pharma 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 forgot to take Bosentan Kern Pharma

If you forgot to take this medication, take the dose as soon as you remember and then continue taking it in your usual schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Bosentan Kern Pharma

If you suddenly stop taking this medication, your symptoms may worsen. Do not stop taking bosentan unless your doctor tells you to. Your doctor may advise you to reduce the dose over a few days before stopping it completely.

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

Like all medicines, Bosentan Kern Pharma can cause side effects, although not everyone will experience them.

The most serious side effects with bosentan are:

• Abnormal liver function that can affect more than 1 in 10 people
• Anemia (decreased blood count) that can affect more than 1 in 10 people. Anemia may occasionally require blood transfusions.

Your liver and blood values will be analyzed 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 (stomach pain)
• Icterus (yellowish color of the skin or the white of the eyes)
• Dark-colored urine
• Itching (pruritus)
• Lethargy or fatigue (unusual or excessive tiredness)
• Pseudogripal syndrome (joint and muscle pain with fever)

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

Other side effects:

Very common(can affect more than 1 in 10 people):

• Headache
• Edema (swelling of the legs and ankles or other signs of fluid retention)

Common(can affect up to 1 in 10 people):

• Rubefaction (skin redness)
• Hypersensitivity reactions (including skin inflammation, itching, and rash)
• Gastroesophageal reflux (acid reflux)
• Dyspepsia (diarrhea)
• Syncope (fainting)
• Palpitations (rapid or irregular heartbeats)
• Low blood pressure
• Nasal congestion

Uncommon(can affect up to 1 in 100 people):

• Trombocytopenia (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 underlying hepatitisand/or jaundice (yellowish color of the skin or the white of the eyes)

Rare(can affect up to 1 in 1,000 people):

• Anaphylaxis (generalized allergic reaction), angioedema (swelling, most often around the eyes, lips, tongue, or throat)
• Cirrhosis (fibrosis) of the liver, hepatic failure (severe alteration of liver function)

Side effects in children and adolescents

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

Cases of blurred vision have also been reported with unknown frequency (cannot be estimated from available data).

Reporting of side effects

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

Keepthis medicationout ofsight and reach of children.

No special storage conditions are required.

Do not use this medicationafter the expiration date that appears on the packagingafter“EXP”.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Dispose of the packaging and unused medicines at the SIGRE collection pointofthepharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.This will help protect the environment.

Composition of Bosentan Kern Pharma

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

-Bosentan Kern Pharma 125 mg:The active ingredient is bosentan. Each tablet contains 125 mg of bosentan (as monohydrate).

-The other componentsare maize pregelatinized starch, povidone, carboxymethylcellulose sodium type A (from potato), magnesium stearate, and opadry orange 03K93638 (a mixture consisting of hydroxypropyl methylcellulose, iron oxide red (E-172), iron oxide yellow (E-172), titanium dioxide (E-171), and triacetin).

Appearance of the product and content of the packaging

Bosentan Kern Pharma 62.5 mg:round tablets, orange-white in color, coated with a film.

PVC/PCTFE/Aluminum blisterscontaining 56 tablets.

Bosentan Kern Pharma 125 mg:oval-shaped tablets, orange-white in color, coated with a film.

PVC/PCTFE/Aluminum blisterscontaining 56tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:May 2024

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