Uses of Bosentan Tablets for Oral Suspension:

• It is used to treat high blood pressure in the lungs.

What do I need to tell my doctor BEFORE I take Bosentan Tablets for Oral Suspension?

• If you have an allergy to bosentan or any other part of bosentan tablets for oral suspension.
• If you are allergic to bosentan tablets for oral suspension; any part of bosentan tablets for oral suspension; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease or raised liver enzymes.
• If you are taking any of these drugs: Cyclosporine or glyburide.
• If you are breast-feeding. Do not breast-feed while you take bosentan tablets for oral suspension.

This is not a list of all drugs or health problems that interact with bosentan tablets for oral suspension.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bosentan tablets for oral suspension with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Bosentan Tablets for Oral Suspension?

For all patients taking bosentan tablets for oral suspension:

• Tell all of your health care providers that you take bosentan tablets for oral suspension. This includes your doctors, nurses, pharmacists, and dentists.
• Do not stop taking bosentan tablets for oral suspension all of a sudden without calling your doctor. Signs of high pressure in the lungs like shortness of breath, dizziness, or weakness may get worse. Talk with your doctor.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• This medicine may lower sperm counts in men. This may affect being able to father a child. Talk with the doctor.
• If you are a woman and you miss a period, have unprotected sex, or think that your birth control has not worked, call your doctor right away.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.

Children:

• If your child starts puberty while taking bosentan tablets for oral suspension, talk with your child's doctor. Your child may be able to get pregnant, even if she has not started her menstrual period.

How is this medicine (Bosentan Tablets for Oral Suspension) best taken?

Use bosentan tablets for oral suspension as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking bosentan tablets for oral suspension as you have been told by your doctor or other health care provider, even if you feel well.
• Mix with water as you have been told before drinking.
• The tablets may be broken in half. Do not break into quarters.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• Joint pain.
• This medicine may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.

What are some other side effects of Bosentan Tablets for Oral Suspension?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Flushing.
• Nose irritation.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Bosentan Tablets for Oral Suspension?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• If you have broken tablets, store the tablet pieces in the opened blister for up to 7 days.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time bosentan tablets for oral suspension is refilled. If you have any questions about bosentan tablets for oral suspension, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.