Riociguat

Warning

Riociguat must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 1 month after treatment. Therefore, female patients must use reliable birth control during treatment and for 1 month after the end of treatment. Ask your doctor which forms of birth control to use while taking this medication. Female patients must take a pregnancy test before starting treatment, take a monthly pregnancy test during treatment, and take a pregnancy test 1 month after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

To receive this medication, all doctors, pharmacists, and female patients must understand, agree to, and carefully follow the requirements of the Adempas REMS program developed by the FDA. These requirements apply to female patients in the United States only. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Precautions

Before taking riociguat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking or history of smoking, low or high blood pressure, other lung conditions (such as pulmonary veno-occlusive disease), a severe loss of body water (dehydration), a severe blockage of blood flow out of the heart.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. See also Warning section.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Side Effects

Headache, dizziness, lightheadedness, fainting, unusual tiredness, heartburn, indigestion, nausea, vomiting, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication has rarely caused serious bleeding. If you notice any of the following unlikely but serious signs of bleeding, tell your doctor right away: unusual bleeding from the vagina, coughing up blood, bleeding around catheter site, signs of stomach/intestinal bleeding (such as black/bloody stools, vomit that contains blood or looks like coffee grounds), signs of bleeding in the brain (such as severe headache, weakness on one side of the body, vision problems, slurred speech, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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