Adenpas Tablet 0.5 mg (Riociguat)

Adult dose

1) Adults o Initial dose Administer 1.0 mg 3 times daily for 2 weeks as the initial dose. This medicine should be taken 3 times daily at approximately 6-8-hour intervals, regardless of food intake. To minimize the potential for hypotension, the initial dose may be started at 0.5 mg 3 times daily. o Dose titration • If systolic blood pressure is ≥95 mmHg and there are no signs or symptoms of hypotension, increase the dose by 0.5 mg per dose up to a maximum of 2.5 mg; dose titration should be performed at 2-week intervals. • If systolic blood pressure is <95 mmHg and there are no signs or symptoms of hypotension, maintain the dose. • If systolic blood pressure is <95 mmHg and signs or symptoms of hypotension are observed, withhold the next 3 doses at any time, and after 24 hours, if clinically acceptable, resume treatment at a dose reduced by 0.5 mg per dose. o Maintenance dose The established maintenance dose for each patient should be maintained provided that no signs or symptoms of hypotension occur. The maximum daily dose of this medicine is 7.5 mg. If a dose is missed, continue with the next scheduled dose. If tolerability is poor, dose reduction may be considered at any time. o Discontinuation of treatment If treatment must be interrupted for 3 days or longer, restart at the initial dose, administered 3 times daily for 2 weeks, and then continue according to the dose titration method described above. o For patients unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or soft food such as applesauce, and administered orally. 2) Dosage in special populations (1) Elderly patients Exposure to this medicine was increased in patients aged 65 years or older; therefore, special caution is needed when individually titrating the dose. (2) Patients with hepatic impairment Exposure to this medicine was increased in patients with moderate hepatic impairment (Child-Pugh B); therefore, special caution is needed when individually titrating the dose. This medicine has not been studied in patients with severe hepatic impairment (Child-Pugh C) and should not be administered to them. (3) Patients with renal impairment Exposure to this medicine was increased in patients with mild, moderate, or severe renal impairment (creatinine clearance 15-80 mL/min); therefore, special caution is needed when individually titrating the dose. This medicine has not been studied in patients with creatinine clearance of 15 mL/min or in patients on dialysis and should not be administered to them. (4) Patients taking strong inhibitors of multiple CYP pathways and P-gp (P-glycoprotein)/BCRP (breast cancer resistance protein) When initiating this medicine in patients taking a stable dose of a strong inhibitor of multiple CYP pathways and P-gp/BCRP [e.g., azole antifungals (ketoconazole, itraconazole, etc.), HIV protease inhibitors (e.g., ritonavir)], consider a starting dose of 0.5 mg 3 times daily to reduce the risk of hypotension. Monitor for signs and symptoms of hypotension at treatment initiation and during treatment (see section “3. Patients requiring careful administration” under Precautions for Use). (5) Smokers Smoking cessation is recommended for smokers. Plasma concentrations of this medicine were lower in smokers than in nonsmokers. Dose adjustment may be necessary in patients who stop smoking or begin smoking during treatment. 3) Switching medications · Discontinue sildenafil at least 24 hours before administering this medicine. · Discontinue tadalafil at least 48 hours before administering this medicine. In patients at risk of hypotension, consider starting this medicine at an initial dose of 0.5 mg. When switching medications, observation for signs or symptoms of hypotension is recommended initially. · Discontinue this medicine at least 24 hours before administering a PDE-5 inhibitor. When switching medications, observation for signs or symptoms of hypotension is recommended initially.

This medication can be harmful to the fetus if administered to pregnant women, so women who may become pregnant must confirm their pregnancy status before, during, and after taking the medication. This medication should not be used by patients allergic to certain ingredients, pregnant women, breastfeeding women, patients with significantly low blood pressure, or those with severe liver or kidney dysfunction. Patients with pulmonary conditions or a high risk of bleeding, as well as those at risk of hypotension, should use this medication cautiously and should frequently monitor their blood pressure and condition while using it. This medication can dilate blood vessels and lower blood pressure; therefore, patients being treated for hypertension or those experiencing symptoms of hypotension should consult a doctor before using it. Patients with slightly impaired liver or kidney function and the elderly should require dosage adjustments and caution. Interactions may occur when taken with other medications, particularly with certain antifungals, antivirals, immunosuppressants, antacids, and antihypertensives, so it is essential to follow a doctor's instructions when taken together. The concurrent use of this medication with other vasodilators such as nitrates or PDE-5 inhibitors can be risky and is contraindicated. Side effects may include headaches, dizziness, dyspepsia, nausea, diarrhea, peripheral edema, etc., and if symptoms are severe, patients should inform their doctor. Smoking may reduce the effectiveness of this medication, so quitting smoking is recommended. Before driving or operating machinery, patients should assess their condition after taking this medication, remaining cautious if experiencing dizziness. Pregnant or breastfeeding women should not use this medication, and women planning pregnancy should use effective contraceptive methods. Safety in children has not been established; thus, it is not recommended for pediatric use. In case of overdose, serious symptoms such as hypotension may occur, and immediate medical attention is necessary, as this medication cannot be removed by dialysis, requiring appropriate care. Finally, this medication should be stored out of reach of children and not transferred to another container for safety.

• headache
• dizziness
• indigestion
• peripheral edema
• nausea
• diarrhea
• vomiting
• anemia
• palpitations
• hypotension

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. Additionally, it is best stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

A white, round, film-coated tablet with a convex shape on both sides, with “0.5” above “R” engraved on one side and the Bayer cross engraved on the other side.

Package unit

42 tablets (21 tablets/PTP packaging x 2)