Leaflet: information for the user

Bosentan SUN 62.5 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, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do 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.

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

2. What you need to know before you start taking Bosentan SUN

3. How to take Bosentan SUN

4. Possible side effects

5. Storage of Bosentan SUN

6. Contents of the pack and additional information

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

Bosentan SUN is used to treat:

•Pulmonary arterial hypertension (PAH):PAH is a serious 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 SUN is used to treat 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' implies marked limitation of physical activity. Some improvements have been observed in patients with PAH class II. 'Class II' implies mild limitation of physical activity. PAH for which Bosentan SUN 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 whichthere is abnormal growth of connective tissue that forms the support of the skin and otherorgans),

•caused by congenital heart defects (birth defects) with abnormal communications

(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 SUN reduces the number of new digital ulcers (on hands and feet) that appear.

Do not take Bosentan SUN:

•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 pregnantwithout using reliable contraceptive methods. Please read the information in the section “Contraceptives” and “Other medicines and Bosentan SUN”

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

If you have any of these conditions, inform your doctor.

Warnings and precautions

Consult 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 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 (low hemoglobin)

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 hemoglobin levels.

Please refer to the Patient Alert Card (inside the Bosentan SUN packaging) for these tests. It is essential to perform regular blood tests while taking Bosentan SUN. 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 treatment with Bosentan SUN. 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 SUN may develop anemia.

If these tests show abnormalities, 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 for pediatric patients with systemic sclerosis and active digital ulceration. See 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 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 medicine used after transplants and to treat psoriasis), which should not be taken with Bosentan SUN.

• sirolimus or tacrolimus, which are medicines used after transplants, and it is not recommended to take them with Bosentan SUN.

• glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), 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 with Bosentan SUN.

• other HIV infection medicines, 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 packaging, you will find a Patient Alert Card that you should read carefully. Your doctor and/or gynecologist will determine an alternative or additional reliable contraceptive method for you.

• other medicines for treating pulmonary hypertension: sildenafil and tadalafil;

• warfarin (an anticoagulant);

• simvastatin (used to treat high cholesterol).

Pregnancy, breastfeeding, and fertility

Pregnant women

Do not take Bosentan SUN if you are pregnant or plan to become pregnant.

Pregnancy tests

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

Contraceptives

If you may become pregnant, use a reliable contraceptive method while taking Bosentan SUN. Your doctor or gynecologist will advise you on reliable contraceptive methods while taking Bosentan SUN. Since Bosentan SUN 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 Bosentan SUN packaging, you will find a Patient Alert Card that you should read carefully. Your doctor and/or gynecologist will determine if you need an alternative or additional reliable contraceptive method. It is recommended to perform a pregnancy test monthly while taking Bosentan SUN and are fertile.

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

Breastfeeding

Bosentan SUN passes into breast milk. It is recommended to stop breastfeeding if you are prescribed Bosentan SUN, as it is not known if this medicine may harm your baby. Inform your doctor about this.

Fertility

If you are a man taking Bosentan SUN, 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. Discuss this with your doctor if you have any doubts or concerns.

Driving and operating machinery

Bosentan SUN has no influence or has a negligible influence on driving and operating machinery. However, Bosentan SUN may cause hypotension (low blood pressure) that may cause dizziness, affect vision, and affect the ability to drive and operate machinery. Therefore, if you feel dizzy or your vision is blurry while taking 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; it is essentially “sodium-free”.

Treatment with Bosentan SUN should only be initiated and monitored by a doctor experienced in the treatment of HAP or systemic sclerosis. Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Bosentan SUN with food and drink

Bosentan SUN can be administered 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 SUN.

Children and adolescents

The recommended dose in children is only for HAP. For children aged 1 year and over, treatment with Bosentan SUN usually starts with 2 mg per kg of body weight twice a day (morning and night); however, some bosentan doses are not possible in children with a body weight below 31 kg. For these patients, a lower-dose bosentan tablet is required. Your doctor will advise you on the dose.

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

How to take Bosentan SUN

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

If you take more Bosentan SUN than you should

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

If you forget to take Bosentan SUN

If you forget to take Bosentan SUN, 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 treatment with Bosentan SUN

If you suddenly stop treatment with Bosentan SUN, your symptoms may worsen. Do not stop taking Bosentan SUN 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 medication, ask your doctor or pharmacist.

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

The most serious side effects with Bosentan SUN 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 SUN

(see section 2). It is essential to have these analyses 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)

• Pseudo-gripal 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 10people):

• Headache

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

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

• Rubefaction (skin redness)

• Hypersensitivity reactions (including skin inflammation, itching, and rash)

• Gastroesophageal reflux (acid reflux)

• Diarrhea

• Syncope (fainting)

• Palpitations (rapid or irregular heartbeats)

• Low blood pressure

• Nasal congestion

Uncommon(can affect up 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 possible exacerbation of hepatitis and/or icterus (yellowish color of the skin or the white of the eyes)

Rare(can affect up to 1 in 1000people):

• 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)

Unknown frequency(cannot be estimated from available data):

• Blurred vision

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, 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:https://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 on the blister after "CAD". The expiration date is the last day of the month indicated.

Shelf life after first opening (only for the bottle): 50 days

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Bosentan SUN 62,5 mg film-coated tablets

• The active ingredient is bosentan. Each tablet contains 62.5 mg of bosentan.
• The other components are maize starch, pregelatinized maize starch, sodium starch glycolate, 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, yellow or light yellow, biconvex, marked with "62.5" on one face and smooth on the other face. The tablets have a diameter of approximately 5.9 mm.

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

Pre-cut single-dose blisters of PVC/PE/PVdC/Al containing 14 x 1 and 56 x 1 film-coated tablets

HDPE containers containing 56 and 100 film-coated tablets.

The HDPE containers are made of high-density polyethylene, white, opaque, with an induction line and a child-resistant cap, with a silica gel desiccant overpack. The contents of the overpack MUST NOT BE INGESTED.

Only some pack sizes may be marketed.

This medicinal product is authorized in the member states of the European Economic Area with 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 Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

Hoofddorp - 2132JH

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

Hoofddorp - 2132JH

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

Last review date of this leaflet:September 2024

Further information is available on the website of the Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/.