Bosentan Ranbaxi

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

Bosentan Ranbaxycontains bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), causing blood vessels to constrict. As a result, bosentan causes blood vessels to dilate; this medicine belongs to a group of medicines called "endothelin receptor antagonists".
Bosentan Ranbaxyis used to treat:
Pulmonary arterial hypertension(PAH): PAH is a disease characterized by severe constriction of blood vessels in the lungs, leading to high blood pressure in the blood vessels of the lungs (pulmonary arteries) that carry blood from the heart to the lungs. This high pressure reduces the amount of oxygen that can enter the blood in the lungs, making physical activity difficult. Bosentan dilates the pulmonary arteries, making it easier for the heart to pump blood. As a result, the pressure decreases, and the symptoms subside.
Bosentan Ranbaxyis used to treat patients with PAH class III to improve exercise capacity (ability to perform physical activity) and alleviate symptoms. The "class" reflects the severity of the disease. Class III is associated with significant limitation of physical activity. Some improvement has also been shown in patients with PAH functional class II. Class II is associated with mild limitation of physical activity. PAH, for which Bosentan Ranbaxyis indicated, may be:

• primary (without a known cause or familial);
• caused by scleroderma (also known as systemic sclerosis, a disease in which there is abnormal growth of connective tissue supporting the skin and other organs);
• caused by congenital heart defects associated with shunts (abnormal blood flow) through the heart and lungs.

Ulcers on the fingertips: (sores on the fingers and toes) in adult patients with systemic scleroderma. Bosentan Ranbaxyreduces the number of new ulcers on the fingers and toes.
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2. Important information before taking Bosentan Ranbaxy

When not to take Bosentan Ranbaxy

• if the patient is allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
• in case of liver disease (consult your doctor)
• if the patient is pregnant or may become pregnant, as they are not using effective contraception; refer to the information in sections "Contraceptives" and "Bosentan Ranbaxy and other medicines".
• if the patient is taking cyclosporine A (a medicine used after transplantation or for the treatment of psoriasis)

If any of the above applies to the patient, they should inform their doctor.

Warnings and precautions

Before starting treatment with Bosentan Ranbaxy, the patient should discuss it with their doctor or pharmacist.

Tests that the doctor will perform before starting treatment

• blood test to determine liver function
• blood test to rule out anemia (low hemoglobin level)
• pregnancy test in women of childbearing age

In some patients taking bosentan, abnormal liver function test results and anemia (low hemoglobin level) have been observed.

Tests that the doctor will perform during treatment

During treatment with Bosentan Ranbaxy, the doctor will order regular blood tests to monitor changes in liver function and hemoglobin levels.
A description of all tests can also be found in the Patient Alert Card (inside the packaging of Bosentan Ranbaxytablets). It is essential to perform regular blood tests while taking Bosentan Ranbaxy. The patient is advised to record the date of the last and next scheduled blood test (according to the doctor's instructions) on the Patient Alert Card to avoid missing it.

Liver function tests

Tests will be performed once a month during treatment with Bosentan Ranbaxy. After a dose increase, an additional test will be performed after 2 weeks.

Blood tests to rule out anemia

Tests will be performed once a month for the first 4 months of treatment, then every 3 months, as anemia may occur in patients taking Bosentan Ranbaxy. If the results are abnormal, the doctor may decide to reduce the dose or discontinue treatment with Bosentan Ranbaxyand perform additional tests to determine the cause.

Children and adolescents

Bosentan Ranbaxyis not recommended for children and adolescents with systemic scleroderma and digital ulcers. See also section 3, "How to take Bosentan Ranbaxy".

Bosentan Ranbaxy and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those obtained without a prescription. In particular, the patient should inform their doctor about taking:

• cyclosporine (a medicine used after transplantation or for the treatment of psoriasis), which should not be taken at the same time as Bosentan Ranbaxy

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• sirolimus or tacrolimus, medicines used after transplants, which are not recommended to be taken at the same time as Bosentan Ranbaxy
• 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 (a medicine for HIV infection), which are not recommended to be taken at the same time as Bosentan Ranbaxy
• other medicines for HIV infection, which may require special monitoring if taken at the same time as Bosentan Ranbaxy
• hormonal contraceptives, which are ineffective as the only method of contraception during treatment with Bosentan Ranbaxy. The Patient Alert Card is included in the packaging of Bosentan Ranbaxytablets. The patient should read it carefully. The doctor or gynecologist will determine the most suitable method of contraception for the patient.
• other medicines used to treat pulmonary hypertension: sildenafil and tadalafil
• warfarin (an anticoagulant medicine)
• simvastatin (a medicine used to treat high cholesterol)

Pregnancy, breastfeeding, and fertility

Women of childbearing age

Bosentan Ranbaxyshould not be taken if the patient is pregnant or plans to become pregnant.

Pregnancy tests

Bosentan Ranbaxymay be harmful to the fetus. If the patient may become pregnant, the doctor will ask for a pregnancy test before starting treatment with Bosentan Ranbaxyand will also ask for regular tests during treatment with Bosentan Ranbaxy.

Contraceptives

If the patient may become pregnant, they should use effective contraception during treatment with Bosentan Ranbaxy. The doctor or gynecologist will recommend effective methods of contraception during treatment with Bosentan Ranbaxy. Bosentan Ranbaxymay reduce the effectiveness of hormonal contraceptives (e.g., oral, injectable, implant, or transdermal patch), so using only this method of contraception is ineffective. Therefore, when using hormonal contraceptives, a mechanical method (e.g., female condom, diaphragm, contraceptive sponge, or the patient's partner should also use a condom) should also be used.
The Patient Alert Card is included in the packaging of Bosentan Ranbaxytablets. The patient should fill it out and bring it to their next doctor's visit, so the doctor or gynecologist can assess whether additional or other effective methods of contraception are needed. During treatment with Bosentan Ranbaxy, it is recommended to perform monthly pregnancy tests in women of childbearing age.
The patient should immediately inform their doctor if they become pregnant while taking Bosentan Ranbaxyor plan to become pregnant in the near future.

Breastfeeding

Bosentan passes into breast milk. After prescribing Bosentan Ranbaxy, breastfeeding should be discontinued, as it is not known whether bosentan in breast milk can harm the child. The patient should discuss this with their doctor.

Fertility

If a male patient takes Bosentan Ranbaxy, it is possible that the medicine may reduce the number of sperm in the semen. It cannot be excluded that this may affect the ability to father a child. If the patient has any questions or concerns about this, they should consult their doctor.

Driving and using machines

Bosentan Ranbaxyhas no or negligible influence on the ability to drive and use machines. However, Bosentan Ranbaxymay cause hypotension (low blood pressure), which can lead to dizziness, blurred vision, and affect the ability to drive and use machines. Therefore, if the patient experiences dizziness or blurred vision while taking Bosentan Ranbaxy, they should not drive, use tools, or operate machines.

Bosentan Ranbaxy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Bosentan Ranbaxy

Treatment with Bosentan Ranbaxyshould be started and supervised by a doctor with experience in treating PAH or systemic scleroderma. This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Taking Bosentan Ranbaxy with food and drink

Bosentan Ranbaxycan be taken with or without food.

Recommended dose

Adults

In adult patients, treatment usually starts with a dose of 62.5 mg twice a day (morning and evening) for the first 4 weeks, then the doctor usually recommends a dose of 125 mg twice a day, depending on the patient's response to Bosentan Ranbaxy.

Children and adolescents

The recommended dose for children applies only to the treatment of PAH. In children aged 1 year and older, treatment with Bosentan Ranbaxyusually starts with a dose of 2 mg/kg body weight twice a day (morning and evening); however, in children with a body weight below 31 kg, some doses of bosentan cannot be administered. The doctor will decide on the dose.

How to take Bosentan Ranbaxy

Bosentan Ranbaxyshould be taken in the morning and evening, with water. The tablets can be taken with or without food.

Taking a higher dose of Bosentan Ranbaxy than recommended

If the patient takes more tablets than recommended, they should immediately consult their doctor.

Missing a dose of Bosentan Ranbaxy

If the patient forgets to take Bosentan Ranbaxy, they should take the missed dose as soon as they remember, and then continue taking the tablets at the usual times. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Bosentan Ranbaxy

Suddenly stopping treatment with Bosentan Ranbaxymay worsen symptoms. The patient should not stop treatment with Bosentan Ranbaxyunless their doctor advises them to do so. The doctor may recommend reducing the dose over a few days before completely stopping the medicine.
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In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bosentan Ranbaxycan cause side effects, although not everybody gets them. The most serious side effects of Bosentan Ranbaxyare:

• Abnormal liver function, which may occur in more than 1 in 10 patients.
• Anemia (low red blood cell count), which may occur in up to 1 in 10 patients. In anemia, blood transfusion may sometimes be necessary.

Liver function and blood morphology parameters will be monitored during treatment with Bosentan Ranbaxy(see section 2). It is essential to perform these tests as recommended by the doctor.
Symptoms of abnormal liver function are:

• nausea (feeling sick),
• vomiting,
• fever (high temperature),
• abdominal pain (stomach pain),
• jaundice (yellowing of the skin or whites of the eyes),
• dark urine,
• itching of the skin,
• lethargy or fatigue (excessive tiredness or exhaustion),
• flu-like symptoms (muscle and joint pain and fever).

If the patient notices any of these symptoms, they should immediately inform their doctor.

Other side effects:

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

• headache
• edema (swelling of the legs and ankles or other signs of fluid retention in the body) Common(may affect up to 1 in 10 people):
• flushing (sudden warmth or redness of the skin)
• hypersensitivity reactions (including skin inflammation, itching, and rash)
• gastroesophageal reflux disease (regurgitation of stomach contents)
• diarrhea
• fainting
• palpitations (rapid or irregular heartbeat)
• low blood pressure
• nasal congestion

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

• thrombocytopenia (low platelet count)
• neutropenia/leukopenia (low white blood cell count)
• elevated liver function test results with hepatitis (including possible exacerbation of existing hepatitis) and/or jaundice (yellowing of the skin or whites of the eyes)

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

• anaphylaxis (generalized allergic reaction), angioedema (swelling that occurs most commonly around the eyes, lips, tongue, or throat)

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• liver cirrhosis (scarring of the liver), liver failure (severe liver dysfunction)

Frequency not known(frequency cannot be estimated from the available data).

• blurred vision

Side effects in children and adolescents

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie
181C 02-222
Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bosentan Ranbaxy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or bottle and carton after "EXP". The expiry date refers to the last day of the month.
Shelf life after first opening (only for bottles): 50 days
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bosentan Ranbaxy contains

• The active substance is bosentan. Each tablet contains 125 mg of bosentan.
• The other ingredients are: cornstarch, cornstarch paste, sodium carboxymethylcellulose, povidone K-30, glycerol dibehenate, magnesium stearate.

The tablet coating (Opadry 21K520019 Yellow) contains: hypromellose, titanium dioxide (E 171), triacetin, talc, ethylcellulose, yellow iron oxide (E 172), red iron oxide (E 172).

What Bosentan Ranbaxy looks like and contents of the pack

Bosentan Ranbaxy125 mg is a film-coated tablet, light orange to orange, oval, biconvex, with "125" embossed on one side and smooth on the other, approximately 11.0 mm long and 5.0 mm wide.
Blisters of PVC/PE/PVDC/Aluminum in a cardboard box containing:
14, 56, and 120 film-coated tablets.
Perforated unit dose blisters of PVC/PE/PVDC/Aluminum in a cardboard box containing:
14 x 1, 56 x 1, and 120 x 1 film-coated tablets
Bottles of HDPE in a cardboard box containing 56 and 100 tablets.
Non-transparent white HDPE bottles with a high-density polyethylene cap and a desiccant sachet containing silica gel
DO NOT SWALLOW the contents of the sachet.
Not all pack sizes may be marketed.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: BOSENTAN BASICS 125 mg Filmtabletten
France: BOSENTAN SUN 125 mg comprimé pelliculé
Italy: Bosentan Sun
Spain: Bosentan Sun 125 mg comprimidos recubiertos con película EFG
Romania: Bosentan Terapia 125 mg comprimate filmate

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer/Importer

Terapia S.A.
Str. Fabricii nr. 124
400632 Cluj-Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29
4440 Tiszavasvári
Hungary
Date of last revision of the leaflet:18.09.2024