GENEPRIFILM-coated tablet 100 milligrams (Sacubitril/Valsartan Sodium Hydrate)

Adult dosage

1. Adults 1) Initial dose: The recommended initial dose of this medicine is 100mg (equivalent to 48.6/51.4mg of sacubitril/valsartan) twice daily. For patients who are not taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), or who were previously taking these medicines at low doses, it is recommended to start with an initial dose of 50mg (equivalent to 24.3/25.7mg of sacubitril/valsartan) twice daily. 2) Maintenance dose: Depending on the patient's tolerability, double the dose of this medicine every 2-4 weeks until the target maintenance dose of 200mg (equivalent to 97.2/102.8mg of sacubitril/valsartan) twice daily is reached. If the patient has problems tolerating the medicine (e.g., symptomatic hypotension, hyperkalemia, or renal dysfunction), consider adjusting concomitant medicines or temporarily reducing the dose of this medicine. 2. Patients with renal impairment For patients with severe renal impairment (eGFR < 30 mL/min/1.73m2), an initial dose of 50mg (equivalent to 24.3/25.7mg of sacubitril/valsartan) twice daily is recommended. Experience with this medicine in patients with severe renal impairment is limited; therefore, use with caution in these patients. No dose adjustment is required in patients with mild (eGFR 60~90 mL/min/1.73m2) to moderate (eGFR 30~60 mL/min/1.73m2) renal impairment. 3. Patients with hepatic impairment For patients with moderate hepatic impairment (Child-Pugh B), an initial dose of 50mg (equivalent to 24.3/25.7mg of sacubitril/valsartan) twice daily is recommended. No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).

This medication can cause severe harm to the fetus and newborn during pregnancy, so it should not be used by women who are pregnant or planning to become pregnant. Women who are of childbearing age should avoid pregnancy for at least 1 week after the last dose of this medication. People allergic to any components of this medication or those with specific liver or kidney disorders should not use it. Severe allergic reactions such as angioedema may occur, so if swelling of the face, lips, or tongue occurs, the use of this medication should be stopped immediately and medical attention should be sought. This medication can lower blood pressure, so symptoms of hypotension may occur, especially in cases of fluid or sodium depletion, caution is necessary. It may affect kidney function, so regular blood tests should be done to monitor kidney function. Due to the risk of increased potassium levels, blood potassium levels should be tested periodically, and caution should be taken when combining with potassium-rich foods or medications. Drug interactions may occur when combining with other antihypertensives, certain diuretics, and analgesics, so it is essential to inform the doctor or pharmacist. Psychological symptoms such as hallucinations or paranoia and sleep disturbances may appear, so consult medical personnel if these symptoms occur immediately. In elderly patients, the effects of the medication may be stronger, so symptoms should be closely monitored and taken with caution. In case of overdose, blood pressure may drop too low, so contact a medical institution immediately for appropriate treatment.

• Renal failure
• hyperkalemia
• hypotension
• anemia
• hypersensitivity
• hypokalemia
• hypoglycemia
• dizziness
• headache
• syncope

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is recommended to keep it in a cool place below 30 degrees Celsius.

Appearance

Light yellow, oval, biconvex film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging × 3), 60 tablets (10 tablets/PTP packaging × 6)