SPL MEDGUIDE SECTION

Acceptable birth control options

Bosentan tablets 32 mg dispersible tablets contain Aspartame. Phenylketonurics: Contains Phenylalanine 1.87 mg per 32 mg dispersible tablet.   See “What are the possible side effects of bosentan tablets for oral suspension?” for more information about side effects.

What are bosentan tablets for oral suspension?    Bosentan tablets for oral suspension is a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.  Bosentan can improve your ability to exercise and can slow the worsening of your physical condition and symptoms. Bosentan lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.     Bosentan tablets for oral suspension are only:     Prescribed by healthcare providers who are enrolled in the Bosentan REMS Program.  Available to people who understand and agree to enroll in the Bosentan REMS Program.

Who should not take bosentan tablets for oral suspension?    Do not take bosentan tablets for oral suspension if you:   are pregnant, plan to become pregnant, or become pregnant during bosentan treatment. Bosentan can cause serious birth defects. All females should read the birth defects section of “What is the most important information I should know about bosentan tablets for oral suspension?” take any of these medicines:   cyclosporine A used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of heart, liver, and kidney transplants glyburide used to treat diabetes  are allergic to bosentan or any of the ingredients in bosentan tablets for oral suspension. See the end of this Medication Guide for a complete list of the ingredients in bosentan tablets for oral suspension. If you have a rash, hives or your lips swell after taking bosentan tablets for oral suspension, it may be a sign of allergy. You should stop taking your bosentan tablets for oral suspension and talk to your healthcare provider.

What should I tell my healthcare provider before taking bosentan tablets for oral suspension?     Bosentan tablets for oral suspension may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:   have liver problems. are breast-feeding or plan to breast feed. Bosentan passes into your breast milk. It is not known if bosentan in breast milk can harm your baby. You and your healthcare provider should decide if you will take bosentan or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bosentan and other medicines may affect how each other works and cause side effects. Especially tell your healthcare provider if you take:   hormone-based birth control, such as pills, shots, patches, and implants. These birth control methods may not work as well when taken with bosentan tablets for oral suspension. simvastatin or other “-statin” medicines used to lower cholesterol rifampin used for tuberculosis ketoconazole, fluconazole, itraconazole, or voriconazole used for fungal infections warfarin sodium used to prevent blood clots ritonavir used to treat HIV  There may be more than one brand name medicine. Ask your healthcare provider if you are not sure if your medicine is one that is listed above.     Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.

How should I take bosentan tablets for oral suspension?     Your healthcare provider will give you detailed information about the Bosentan REMS Program.   Bosentan tablets for oral suspension are only available through certified pharmacies. You will only receive a 30-day supply of bosentan tablets for oral suspension at one time. Take bosentan tablets for oral suspension exactly as prescribed. Your healthcare provider will tell you how much bosentan tablets for oral suspension to take and when to take it. In most cases, you will take 1 tablet in the morning and 1 in the evening. You can take bosentan tablets for oral suspension orally with or without food. If you take more than the prescribed dose of bosentan tablets for oral suspension, call your healthcare provider right away. If you miss a dose of bosentan tablets for oral suspension, take your tablet as soon as you remember. Do not take 2 doses at the same time. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not stop taking bosentan tablets for oral suspension unless your healthcare provider tells you to. Suddenly stopping your treatment may cause your symptoms to get worse. If you need to stop taking bosentan tablets for oral suspension, speak with your healthcare provider about the right way to stop. If necessary, the 32 mg dispersible tablet can be divided into halves by breaking along a line cut into the surface. Hold the tablet between the thumb and index finger on either side of the line, with the line facing upwards, and break the tablet along the line (see figure below). The dispersible tablet should not be broken into quarters. Each 32 mg dispersible tablet, or tablet part, can be dispersed in a minimal amount of water to make a liquid medicine immediately before administration. When the tablet has fully dispersed, the liquid should be administered to the patient.

What are the possible side effects of bosentan tablets for oral suspension?     Bosentan tablets for oral suspension can cause serious side effects, including:   See “What is the most important information I should know about bosentan tablets for oral suspension?” Fluid retention and swelling of your ankles and legs. Bosentan tablets for oral suspension can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this. Lower Sperm Count. Some men who take bosentan tablets for oral suspension may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is a concern for you. Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with bosentan tablets for oral suspension.     The most common side effects of bosentan tablets for oral suspension include:   respiratory tract infection headache fainting flushing low blood pressure inflamed nose passages (sinusitis) joint pain irregular heart beats     Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of bosentan tablets for oral suspension. For more information, ask your doctor or pharmacist.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effect to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

How should I store bosentan tablets for oral suspension?      Store bosentan tablets for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). Dispersible tablets that have been broken to adjust the dose of medicine can be stored at room temperature, between 68°F to 77°F (20°C to 25°C) and should be used within 7 days of having been broken. Tablet pieces may be returned to the opened blister and stored there out of reach of children for up to 7 days.  Keep bosentan tablets for oral suspension and all medicines out of the reach of children.

General information about bosentan tablets for oral suspension     Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bosentan tablets for oral suspension for a condition for which it was not prescribed. Do not give bosentan tablets for oral suspension to other people, even if they have the same symptoms that you have. It may harm them.     This Medication Guide summarizes the most important information about bosentan tablets for oral suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about bosentan tablets for oral suspension that is written for health professionals.

What are the ingredients in bosentan tablets for oral suspension?     Active ingredient: bosentan     Inactive ingredients in 32 mg dispersible tablets: microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, tutti frutti flavor, aspartame, acesulfame potassium and magnesium stearate.    Manufactured by: Natco Pharma Limited Parawada – 531019, India.   Distributed by: Lupin Pharmaceuticals, Inc. Naples FL 34108 United States

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: October 2025