Procoralan Tablet 5mg (Ivabradine Hydrochloride)

Adult dose

1. Symptomatic treatment of chronic stable angina Adults: Initiation of treatment or dose escalation should preferably be determined based on the results of continuous heart rate measurement, electrocardiography, or ambulatory 24-hour monitoring. In patients younger than 75 years, the initial dose should not exceed 5 milligrams per dose, twice daily, and should be taken immediately after breakfast and dinner. If symptoms persist 3~4 weeks after starting treatment, the initial dose is tolerated, and the resting heart rate remains at least 60 beats per minute, the dose may be increased to the next higher dose in patients receiving 2.5 milligrams per dose twice daily or 5 milligrams per dose twice daily. The maintenance dose should not exceed 7.5 milligrams per dose twice daily. If there is no improvement in angina symptoms within 3 months of starting treatment, treatment with this medicine should be discontinued. In addition, discontinuation of treatment should be considered if there is no clinically meaningful reduction in resting heart rate within 3 months and only a limited symptomatic response. If the resting heart rate decreases to below 50 beats per minute or symptoms of bradycardia (e.g., dizziness, fatigue, or hypotension) occur during treatment with this medicine, the dose should be reduced and may be adjusted down to the lowest dose of 2.5 milligrams per dose twice daily (1/2 tablet of 5 milligrams per dose twice daily). Monitor the heart rate after dose reduction (see section ‘4. General Precautions’). If a heart rate below 50 beats per minute or symptoms of bradycardia persist despite dose reduction, treatment should be discontinued. In clinical trials, this medicine was administered in combination with a low dose of a beta-blocker (atenolol 50 milligrams once daily). 2. Chronic heart failure Treatment with this medicine should be initiated when the patient is in a stable condition without acute symptoms of heart failure. Adults: The recommended initial dose is 5 milligrams per dose twice daily, taken immediately after breakfast and dinner. If, 2 weeks after starting treatment, the resting heart rate remains consistently above 60 beats per minute, the dose may be increased to 7.5 milligrams per dose twice daily. If the resting heart rate decreases consistently to below 50 beats per minute or symptoms of bradycardia (e.g., dizziness, fatigue, or hypotension) occur, the dose may be reduced to 2.5 milligrams per dose twice daily. If the heart rate is 50~60 beats per minute, maintain the dose at 5 milligrams per dose twice daily. If, while taking 5 milligrams or 7.5 milligrams per dose twice daily, the resting heart rate consistently decreases to below 50 beats per minute or symptoms of bradycardia (e.g., dizziness, fatigue, or hypotension) occur, the dose should be reduced stepwise. If, while taking 2.5 milligrams or 5 milligrams per dose twice daily, the resting heart rate consistently exceeds 60 beats per minute, the dose may be increased stepwise. Treatment should be discontinued if a heart rate below 50 beats per minute or symptoms of bradycardia persist. 3. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment, but this medicine should be administered with caution in patients with moderate hepatic impairment. There is no experience with use in patients with severe hepatic impairment, and this medicine should not be administered because a substantial increase in systemic exposure is expected (see sections 1. Do not administer to the following patients and 2. Administer with caution to the following patients under Precautions for Use). 4. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance: 15mL/min or higher). Use of this medicine is not recommended in patients with severe renal impairment (creatinine clearance: below 15mL/min), because experience with its use is limited. 5. Older adults For older adults aged 75 years and over, administration of a low initial dose (2.5 milligrams per dose twice daily) should be considered.

Child dose

The safety and efficacy of this medicine for the treatment of chronic heart failure have not been established in pediatric patients under 18 years of age. Although data on pediatric use are available, administration of this medicine is not recommended.

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to this medication, have a heart rate that is too low, have severely compromised heart function, are suffering from acute myocardial infarction, have severe hypotension, or are dependent on a cardiac pacemaker. Additionally, patients with severely impaired liver function or specific genetic lactose intolerance should not take this medication. This medication has the potential to lower heart rate; therefore, if the heart rate falls excessively low or symptoms of bradycardia (such as dizziness, fatigue, hypotension, etc.) occur, the dose should be reduced or the medication should be discontinued. Patients with cardiac arrhythmias or atrial fibrillation should use this medication with caution, and regular monitoring of heart condition is required as there is a risk of developing atrial fibrillation. This medication should not be taken with certain antifungals, some antibiotics, and HIV therapies, and concomitant use with grapefruit juice should be avoided. Additionally, it should not be taken with calcium channel blockers like verapamil or diltiazem. Pregnant or nursing women should not take this medication, and women of childbearing age should use appropriate contraceptive methods. In case of overdose, heart rate may drop severely, requiring professional treatment. This medication can induce visual phenomena of temporary bright lights when light intensity changes abruptly, so caution is especially necessary during nighttime driving. Lastly, this medication should be kept out of reach of children and should not be transferred to other containers.

Luminescent phenomenon (photic phenomenon), bradycardia, headache, dizziness, syncope, blurred vision, diplopia, vertigo, first-degree atrioventricular block, ventricular premature contraction, atrial fibrillation, palpitations, ventricular ectopic contraction, second-degree atrioventricular block, third-degree atrioventricular block, sick sinus syndrome, uncontrolled blood pressure, hypotension, dyspnea, nausea, constipation, diarrhea, abdominal pain, angioedema, rash, erythema, pruritus, urticaria, muscle cramps, weakness, fatigue, malaise, elevated blood creatinine, QT interval prolongation, worsening heart failure, chest pain, blood in stool, asthenia, death, cardiomyopathy, cardiac arrest, sepsis, pleural effusion, exacerbation of chronic obstructive pulmonary disease, vomiting, cerebral infarction, diabetes, aneurysm, atrial tachycardia, ventricular tachycardia, pericardial effusion, dysphagia, gastrointestinal bleeding, hypokalemia, azotemia, asthma, pneumonia, pulmonary edema, pulmonary fibrosis, hematoma, worsening dyspnea, chest pain, dyspepsia, peripheral edema, gynecomastia, blepharitis, gastritis, hyponatremia, hemorrhoids, weight loss, oliguria, leg pain, leg weakness, thirst, sensory abnormalities, sensory loss, dry eye, hypertension, myalgia, arthralgia, tinnitus, cerebral infarction, back pain, viral infection, abdominal distension, anemia, pericarditis, atrial tachycardia, ventricular tachycardia, pericardial effusion, blepharitis, gynecomastia, dysphagia, gastritis, gastrointestinal bleeding, hyponatremia, asthma, hemorrhoids, weight loss, oliguria, pulmonary fibrosis, hematoma

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is essential to maintain the storage temperature between 1 and 30 degrees Celsius room temperature. By storing it this way, the efficacy of the medication can be well preserved.

Appearance

Oblong film-coated tablet with a cloudy yellow-orange color, engraved with the number '5' on one side

Package unit

56 tablets (14 tablets/PTP x 4)