Adempas 2 mg Tablet (Riociguat)

Adult dose

1) Adults o Initial dose The initial dose is 1.0 mg per dose, 3 times daily for 2 weeks. 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 0.5mg 3 times daily. o Dose titration • If systolic blood pressure is 95 mmHg or higher 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 less than 95 mmHg and there are no signs or symptoms of hypotension, maintain the dose. • If systolic blood pressure is less than 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 individualized maintenance dose established 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 Interruption of treatment If treatment must be interrupted for 3 days or more, restart at the initial dose, administered 3 times daily for 2 weeks, and then continue treatment according to the dose titration method described above. o For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or soft food such as applesauce, and administered orally. 2) Administration in special populations (1) Elderly patients Exposure to this medicine is increased in elderly patients aged 65 years or older; therefore, special care is needed when individually titrating the dose. (2) Patients with hepatic impairment Exposure to this medicine is increased in patients with moderate hepatic impairment (Child Pugh B); therefore, special care 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 is increased in patients with mild, moderate, or severe renal impairment (creatinine clearance 15-80 mL/min); therefore, special care is needed when individually titrating the dose. This medicine has not been studied in patients with a creatinine clearance of 15 mL/min or in patients on dialysis and should not be administered to them. (4) Patients taking strong dual or multiple pathway CYP and P-gp (P-glycoprotein) / BCRP (Breast cancer resistance protein) inhibitors When initiating this medicine in patients taking a stable dose of strong dual or multiple pathway CYP and P-gp/BCRP inhibitors [e.g., azole antifungals (ketoconazole, itraconazole, etc.), HIV protease inhibitors (e.g., ritonavir, etc.)], consider a starting dose of 0.5mg 3 times daily to reduce the risk of hypotension. Monitor for signs and symptoms of hypotension at the start of treatment and during treatment (see section ‘3. Patients for whom administration requires caution’ under Precautions for Use). (5) Smokers Smoking cessation is recommended for smokers. Blood concentrations of this medicine were lower in smokers than in nonsmokers. Dose adjustment of this medicine may be necessary in patients who stop smoking or start smoking during treatment. 3) Switching medications · Discontinue sildenafil at least 24 hours before starting this medicine. · Discontinue tadalafil at least 48 hours before starting this medicine. For patients at risk of hypotension, consider starting this medicine at an initial dose of 0.5mg. 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 should not be administered to pregnant women, and women of childbearing potential should confirm their pregnancy status before, during, and after treatment with this medication. Additionally, effective contraceptive methods should be used to prevent pregnancy during treatment and for one month after completing treatment. Patients who are allergic to any ingredients in this medication, pregnant women, women of childbearing potential, and nursing mothers should not take this medication. Particularly, it is very dangerous to take this medication in combination with certain drugs such as nitrate preparations, nitric oxide donors, and PDE-5 inhibitors, and such combinations should be avoided. Patients with excessively low blood pressure, severely impaired liver and kidney function, severe liver disease, and specific lung diseases should also not take this medication. Patients with pulmonary venous obstructive disease, those at high risk of respiratory bleeding, those at risk of hypotension, those with impaired liver or kidney function, and elderly patients should use this medication with caution, and dosage adjustments may be necessary under a doctor's guidance. This medication has a vasodilatory effect that may cause hypotension, so if dizziness or symptoms of low blood pressure occur during use, the patient should consult a doctor immediately. Moreover, this medication may commonly cause side effects such as headaches, dizziness, dyspepsia, nausea, diarrhea, vomiting, and peripheral edema, so if these symptoms persist or worsen, the patient should inform a healthcare professional. Smokers are advised to quit smoking as it may reduce the effectiveness of this medication, and they should carefully check their condition after taking this medication before driving or operating machinery. This medication may interact with certain antifungal agents, antiviral drugs, immunosuppressants, etc., so patients taking other medications should inform their doctor or pharmacist. In cases of overdose, serious hypotension may occur, requiring immediate medical attention, and this medication is not eliminated by hemodialysis, so caution is required. When storing, keep this medication out of reach of children and do not transfer it to other containers to maintain the quality of the medication.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the safe preservation of the medication's effectiveness.

Appearance

A round, film-coated tablet that is light orange, convex on both sides, with 'R 2' engraved on one side and the Bayer cross engraved on the other side.

Package unit

42 tablets (21 tablets/PTP packaging x 2)