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This safety information outlines important considerations for the use of Riociguat (Adempas) and highlights potential risks, necessary precautions, and instructions for specific populations. Please read carefully and consult your healthcare provider if you have any questions or concerns.

• Pregnancy Precautions: Riociguat should not be used during pregnancy due to the risk of severe harm to an unborn baby. Women of childbearing potential must undergo a pregnancy test prior to starting treatment, monthly during treatment, and one month after treatment completion. Reliable birth control methods should be used throughout the treatment period and for one month afterward. Discuss with your doctor which birth control methods are appropriate. If you suspect pregnancy, inform your healthcare provider immediately. In the United States, Riociguat is only available through the REMS program due to these risks.

• Low Blood Pressure: Riociguat can cause significant drops in blood pressure, leading to dizziness, fatigue, and lightheadedness. Certain medications may exacerbate these effects. To minimize dizziness or fainting, sit or lie down when taking the medication, and change positions slowly. Seek emergency help if you experience severe symptoms such as fainting, irregular heartbeat, nausea, or chest pain.

• Bleeding Risks: Although uncommon, Riociguat may increase the risk of bleeding, especially if you are taking other blood-thinning medications. Report any unusual bleeding, blood in stools or urine, or excessive dizziness to your doctor. In case of falls or head injuries, seek immediate medical attention as there may be internal bleeding.

• Pulmonary Blockage: Rarely, Riociguat can cause fibrous tissue build-up in lung veins, leading to pulmonary veno-occlusive disease. If symptoms such as persistent coughing, shortness of breath, or chest pain occur, contact your healthcare provider promptly.

• Contraindications: Do not use Riociguat if you are pregnant, taking medications like nitrates, nitric oxide donors, other sGC stimulators, or phosphodiesterase inhibitors (e.g., Viagra), or have a history of idiopathic interstitial pneumonias. Discuss your medical history thoroughly with your healthcare provider to ensure the safe use of this medication.

When taking this medication, some common side effects may occur, but they are generally mild and manageable. These include headaches, indigestion or stomach irritation, dizziness, nausea, diarrhea, low blood pressure, vomiting, anemia, reflux or heartburn, constipation, and unusual tiredness. If any of these effects persist or worsen, it is advisable to consult your healthcare provider.

In addition to these common issues, some individuals may experience side effects such as stuffy nose, nosebleeds, difficulty swallowing, bloating, or fluid retention in the arms or legs. While these are less common, they should still be discussed with a healthcare provider if they occur.

It is crucial to be aware of more severe side effects, although they are rare. These include dangerously low blood pressure, characterized by symptoms like dizziness, lightheadedness, pale skin, and fainting. Serious bleeding may also occur, with signs such as vomiting blood, bloody or dark stools, and severe stomach pain. Another potential risk is a blockage in the lungs, which can cause dizziness, trouble breathing, irregular heartbeat, chest pain, sweating, and coughing. If you experience any of these serious symptoms, seek immediate medical attention.

A very serious allergic reaction to this medication is also rare, but if you notice symptoms such as rash, itching, swelling, severe dizziness, or trouble breathing, urgent medical help is required. Always be vigilant about any new or unusual symptoms and consult your healthcare provider for advice.