Berkub Tablet 10 mg (Vericiguat (uncoated))

Adult dose

1. Adults The recommended starting dose of this medicine is 2.5mg once daily. Take with food. Depending on the patient's tolerability, double the dose approximately every 2 weeks until the target maintenance dose of 10mg once daily is reached. If the patient does not tolerate the medicine well (systolic blood pressure below 90 mmHg or symptomatic hypotension), reduce the dose or discontinue treatment. Do not initiate treatment with this medicine if systolic blood pressure is below 100 mmHg. For patients unable to swallow the tablet whole, this medicine may be crushed and mixed with water immediately before taking it. (See 11. Information for healthcare professionals, 2) Pharmacokinetic information) Missed dose: If a dose is missed, take it as soon as possible on the same day. Do not take this medicine twice on the same day. 2. Older adults No dose adjustment is necessary in older adults. (See 9. Use in older adults and 11. Information for healthcare professionals, 2) Pharmacokinetic information) 3. Patients with renal impairment No dose adjustment is necessary in patients with eGFR≥15mL/min/1.73m2 who are not receiving dialysis. This medicine has not been studied in patients with eGFR<15 mL/min/1.73m2 or in patients receiving dialysis at treatment initiation; therefore, it is not recommended for these patients. (See 11. Information for healthcare professionals, 2) Pharmacokinetic information) 4. Patients with hepatic impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment; therefore, it is not recommended for these patients. (See 11. Information for healthcare professionals, 2) Pharmacokinetic information)

This medication must not be administered to pregnant women as it may harm the fetus. Women of childbearing potential must confirm pregnancy before taking this medication, and during treatment and for one month after discontinuation, effective contraception must be used to prevent pregnancy. Patients with an allergy to any component of this medication, those who are taking specific other medications, and patients with genetic lactose-related disorders should not use this medication. Patients with low blood pressure or symptomatic hypotension should exercise particular caution when using this medication, and if blood pressure is very low, the dose may need to be reduced or administration stopped. It is not recommended to use this medication in patients with weak heart function in conjunction with certain other cardiac medications (e.g., PDE-5 inhibitors or long-acting nitrate preparations). Administration of this medication is not recommended in patients with severely impaired kidney function or those on dialysis, as well as in patients with severe liver disease. This medication may cause side effects such as dizziness, headache, nausea, vomiting, dyspepsia, gastroesophageal reflux disease, hypotension, and anemia, so if any unusual symptoms occur, immediate consultation with healthcare providers is necessary. This medication may cause symptomatic hypotension, thus patients with low blood pressure or a history of hypotension should be especially cautious. There are medications that cannot be used in conjunction with this one; therefore, if taking other medications, be sure to consult a professional. Pregnant or breastfeeding women should not take this medication, and if breastfeeding, they should stop nursing while taking this medication. In children, safety and efficacy have not been established, so its use is not recommended. Elderly patients can use this medication without special dose adjustments, but caution is required as some elderly patients may be more sensitive to side effects. In case of overdose, hypotension may occur; therefore, if an overdose is suspected, visit a medical institution immediately for appropriate treatment.

• Anemia
• nausea
• dyspepsia
• vomiting
• gastroesophageal reflux disease
• dizziness
• headache
• hypotension

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at a cool temperature between 2 to 30 degrees Celsius to maintain the drug's efficacy.

Appearance

Biconvex round film-coated tablet in yellow-orange color

Package unit

Domestic - 28 tablets/box [(14 tablets/blister x 2)]