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Riociguat

Generic Name: Riociguat (rye oh SIG ue at)
Brand Name: Adempas

Warning

  • Do not take riociguat if you are pregnant. This medicine may cause harm to the unborn baby if you take it while you are pregnant. A pregnancy test will be done before starting this medicine to show that you are NOT pregnant. Pregnancy tests will also be done every month while you take riociguat and for 1 month after you stop taking it. If you get pregnant or plan on getting pregnant while taking this medicine, call your doctor right away.
  • Use 2 kinds of birth control that you can trust during care and for 1 month after care ends.
  • Females may only get riociguat through a special program. Talk with your doctor.

Uses of Riociguat:

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

What do I need to tell my doctor BEFORE I take Riociguat?

  • If you have an allergy to riociguat or any other part of this medicine.
  • 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 a health problem called pulmonary veno-occlusive disease (PVOD).
  • If you have pneumonia.
  • If you are taking any of these drugs: Amyl nitrate, avanafil, dipyridamole, a nitrate drug like nitroglycerin, sildenafil, tadalafil, theophylline, or vardenafil.
  • If you are breast-feeding. Do not breast-feed while you take riociguat.

This is not a list of all drugs or health problems that interact with this medicine.

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 riociguat 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 Riociguat?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how riociguat affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Very bad and sometimes deadly bleeding problems have happened with this medicine. Talk with the doctor.
  • If you start or stop smoking, talk with your doctor. How much drug you take may need to be changed.
  • Have your blood pressure checked often. Talk with your doctor.
  • Do not take riociguat within 24 hours of taking sildenafil. Do not take this medicine within 24 hours before or 48 hours after taking tadalafil.
  • 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.

How is this medicine (Riociguat) best taken?

Use riociguat as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • If you cannot swallow tablets, the tablet may be crushed and mixed with water or soft food like applesauce. Take the mixture right away. Do not store for future use.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not take antacids that have aluminum or magnesium in them within 1 hour of riociguat.
  • Your dose may be changed if you have side effects.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you miss 3 days of this medicine, call your doctor to find out what to do.

Dosage Information (comprehensive)

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Dizziness or passing out.
  • A heartbeat that does not feel normal.
  • Trouble swallowing.
  • Swelling of belly.
  • Swelling in the arms or legs.
  • Chest pain.
  • Pale skin.
  • Feeling very tired or weak.

What are some other side effects of Riociguat?

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.
  • Upset stomach or throwing up.
  • Heartburn.
  • Loose stools (diarrhea).
  • Hard stools (constipation).

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

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 Riociguat?

  • 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.
  • Check with your pharmacist about how to throw out unused drugs.

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.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time riociguat is refilled. If you have any questions about this medicine, 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.

This information should not be used to decide whether or not to take riociguat or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to riociguat. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017

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