ACT Bosentan; Mylan-Bosentan; PMS-Bosentan; Sandoz-Bosentan; Teva-Bosentan; Tracleer
- This drug may cause liver problems in some patients. Blood tests will be needed to watch for any liver problems. Talk with the doctor.
- Your child will be closely watched by the doctor.
- Only patients in the T.A.P. Program may get this drug. Talk with the doctor.
If your child is pregnant:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
- Do not let your child take this drug if she is pregnant. A pregnancy test will be done to show that your child is NOT pregnant before starting this drug.
If your child is or may be sexually active:
- A pregnancy test will be done every month during care.
- Have your child use 2 kinds of birth control to prevent pregnancy during care and for 1 month after care ends.
- It is used to treat high pressure in the lungs.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has liver disease.
- If your child is taking any of these drugs: Cyclosporine or glyburide.
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Do not stop giving this drug to your child all of a sudden. Signs of high pressure in the lungs like shortness of breath, dizziness, or weakness may get worse. Talk with the doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- This drug may lower sperm counts in males. Talk with the doctor.
If your child is or may be sexually active:
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Be sure your child uses some other kind of birth control also like a condom when taking this drug.
- If your child misses her period, has unprotected sex, or thinks that her birth control has not worked, call the doctor right away.
- If your child gets pregnant while taking this drug, call the doctor right away.
If your child is breast-feeding a baby:
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
- 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Feeling very tired or weak.
- Shortness of breath, a big weight gain, swelling in the arms or legs.
- Chest pain or pressure.
- Very bad dizziness or passing out.
- Fever or chills.
- Sore throat.
- A heartbeat that does not feel normal.
- Joint pain.
- Any bruising or bleeding.
- Nose and throat irritation.
- Give this drug at the same time of day.
- To gain the most benefit, do not miss giving your child doses.
- Give as you have been told, even if your child feels well.
- Give this drug with or without food.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.