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(rye'' oh sig' ue at)Do not take riociguat if you are pregnant or plan to become pregnant. Riociguat may harm the fetus. If you are sexually active and able to become pregnant, you should not begin taking riociguat until a pregnancy test has shown that you are not pregnant. You must use reliable methods of birth control during treatment and for one month after stopping riociguat. Do not have unprotected sex. Talk to your doctor about birth control methods that are effective and will work for you. Call your doctor immediately if you miss a menstrual period or think you may be pregnant while you are taking riociguat. If you are a parent or guardian of a female who had not yet reached puberty, check your child regularly to see if she is developing any signs of puberty (breast buds, pubic hair )and let her doctor know about any changes. Your child may reach puberty before having her first menstrual period. Because of the risk of birth defects, riociguat is available only through a special restricted distribution program. A program called Adempas Risk Evaluation and Mitigation Strategies (REMS) Program has been set up for all female patients to make sure that they are tested for pregnancy every month during treatment and for 1 month after stopping riociguat.Female patients can get riociguat only if they are registered with Adempas REMS Program. During enrollment you will choose a certified specialty pharmacy that will ship your medication to you. Ask your doctor if you have any questions about how you will receive your medication. Talk to your doctor about the risks of taking riociguat.
Before taking riociguat,
- tell your doctor and pharmacist if you are allergic to riociguat, any other medications, or any of the ingredients in riociguat tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor if you are taking or have recently taken a nitrate such as isosorbide dinitrate (Isordil, in BiDil), isosorbide mononitrate (Monoket), or nitroglycerin (Nitro-Dur, Nitromist, Nitrostat, Minitran, Rectiv, others),; phosphodiesterase inhibitors (PDE-5) such as avanafil (Stendra), sildenafil (Revatio, Viagra), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn); or if you are taking dipyridamole (Persantine, in Aggrenox), or theophylline (Theo-24, Theochron, Theolair, others). Your doctor will probably tell you not to take riociguat if you are taking this one or more of these medications. Do not take riociguat within 24 hours before or after taking sildenafil or within 24 hours before or 48 hours after taking tadalafil.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole (Extina, Nizoral, Xolegel); HIV protease inhibitors including ritonavir (Norvir, in Kaletra); certain medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol, others), phenobarbital, and phenytoin (Dilantin, Phenytek); and medications for high blood pressure. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others), take them 1 hour before or 1 hour after taking riociguat.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have a pulmonary hypertension with idiopathic interstitial pneumonia (PH-IIP; lung disease). Your doctor will probably tell you not to take riociguat.
- tell your doctor if you currently smoke or start or stop smoking during treatment. Also tell your doctor if you have recently had diarrhea, vomiting, or sweating a lot which may have caused dehydration (loss of a large amount of body fluids); any bleeding from your lung(s); if you have had a procedure to stop you from coughing up blood; if you have low blood pressure, pulmonary veno-occlusive disease (a blockage of veins in the lungs); or heart, kidney, or liver disease.
- tell your doctor if you are breastfeeding. Do not breastfeed while you are taking riociguat.
- you should know that riociguat can cause dizziness and lightheadedness. Do not drive a car or operate machinery until you know how this medication affects you.
- upset stomach
- swelling of your hands, legs, feet, and ankles
- coughing up pink, frothy sputum or blood
- chest pain
- shortness of breath