Bosentan Oral Tablet (BOSENTAN - ORAL)

For high blood pressure in the lungs.

Brand Name(s): Tracleer

Generic Name: Bosentan

Instructions

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

Use effective birth control to avoid pregnancy.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

If you drink more than a few alcoholic beverages each day, ask your doctor whether you should be on this medicine.

Do not breastfeed while on this medicine.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

Women must use reliable forms of birth control while taking this medicine and for 1 month after stopping to prevent pregnancy.

Female patients of childbearing age should have monthly pregnancy tests during treatment to make sure they are not pregnant.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

This medicine may reduce sperm count.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • dizziness
  • feeling of heat or flushing
  • pain in the joints
  • stuffy nose

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • cough up blood
  • swelling of the legs, feet, and hands
  • fainting
  • fast or irregular heart beats
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • shortness of breath
  • sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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