Aprocitentan Oral Tablet (APROCITENTAN - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

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.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

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

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

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.

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

Cautions

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

Do not use the medication any more than instructed.

Do not breastfeed while on this medicine.

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

Women of childbearing age should have a negative pregnancy test before starting this medicine.

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

Women of childbearing age should have monthly pregnancy tests while using this medicine and for 1 month after stopping 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.

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

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

• swelling of the legs, feet, and hands
• rapid heartbeat
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• shortness of breath
• unusual or unexplained tiredness or weakness
• 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.