Geneprefilm Coated Tablet 200mg (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 should not be administered to pregnant women or women of childbearing age as it can cause serious harm to the fetus and newborn, or even result in death. Women of childbearing potential are advised to use contraception for up to one week after taking this medication and must discontinue use immediately if pregnancy is confirmed during treatment. This medication is not to be administered to patients with allergies to certain components, those recently taking ACE inhibitors, those with a history of angioedema, severe liver impairment, or severe kidney impairment. Serious side effects such as hyperkalemia, hypotension, and renal dysfunction may occur; hence, caution is required for patients who exhibit these symptoms or are at high risk. If angioedema occurs, discontinue use of this medication immediately and seek appropriate medical treatment. Patients with a history of angioedema should not use this medication again. This medication can lower blood pressure, so if hypotensive symptoms appear, dosage adjustments for diuretics or other antihypertensives may be necessary. Patients with reduced kidney function should undergo frequent renal function tests. Care should be taken when combining with NSAIDs due to the increased risk of worsening renal function. This medication may elevate serum potassium levels, so serum potassium concentrations should be regularly monitored when taken with potassium-sparing diuretics or potassium supplements. Moreover, this medication can interact with other antihypertensives, certain diuretics, statins, lithium, PDE5 inhibitors, among others, requiring caution when taken with other medications. Generally, elderly patients do not require dosage adjustments, but they should be observed closely due to the risk of excessive blood pressure lowering which may lead to strokes or other complications. In cases of overdose, hypotension is the most common symptom, and appropriate symptomatic treatment is necessary. This medication is difficult to remove through hemodialysis; therefore, consult medical staff immediately in case of overdose.

• Kidney failure
• hyperkalemia
• hypotension
• hypokalemia
• hypoglycemia
• dizziness
• headache
• syncope
• orthostatic dizziness
• vertigo

Store this medication in a tightly closed container to protect it from air and moisture, and it is advisable to keep it in a cool place below 30 degrees Celsius. Storing it this way will help maintain its effectiveness and prevent degradation.

Appearance

Film-coated tablet that is oval-shaped, pink, and biconvex on both sides

Package unit

60 tablets (10 tablets/PTP packaging × 6)