Dosage form:

• Film coated tablet 10 mg

What is this drug used for?

• It is used to treat high blood pressure in the lungs (pulmonary hypertension).

Important notes before taking Macitentan:

• If you have an allergy to macitentan or any other part of this drug.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have anemia.
• If you have a health problem called pulmonary veno-occlusive disease (PVOD).
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
• If you are breast-feeding. Do not breast-feed while you take this drug.
• 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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Important notes while taking Macitentan:

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Low red blood cell levels have happened with this drug. Sometimes, this has led to anemia and the need for a blood transfusion. If you have anemia or have been told that you have a low red blood cell level, talk with your doctor.
• Swelling and extra fluid in the body have happened with this drug. Some people have had to take other drugs to treat this. Sometimes, people have had to go to the hospital to be treated for heart failure. Talk with the doctor.
• This drug may affect sperm 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 get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away.
• If your child started taking this drug before puberty, talk with the doctor. Call the doctor right away if breast buds or pubic hair begin to develop or if your child starts her menstrual period.

Side effects of Macitentan

• 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.
• 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.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Feeling very tired or weak.
• Trouble breathing that is new or worse.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Cough.
• Headache.
• Stuffy nose.
• Sore throat.
• Flu-like signs.
• Irritation of the airways (bronchitis).
• 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.

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.

How do I store and/or throw out this drug?

• 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.