Dirofin Sustained Release 2.5 mg (Felodipine)

Adult dose

Swallow this medicine whole with water. Do not divide, chew, or crush it. Hypertension: The initial dose of felodipine is 5㎎ orally once daily, and the maintenance dose is 5-10㎎ orally once daily in the morning. Do not exceed a maximum daily dose of 20㎎. This medicine may be administered concomitantly with a β-blocker or diuretic, and may be administered as monotherapy when other antihypertensive agents are inappropriate. Adjust the dose according to the patient's response to treatment. Stable angina: Administer an initial dose of 5㎎ once daily; the dose may be increased to 10㎎ if needed. This medicine may be administered concomitantly when a β-blocker does not provide an adequate response. Adjust the dose according to the patient's response to treatment. Elderly patients: Administer with caution while monitoring the patient's condition, including consideration of an initial dose of 2.5㎎ once daily. Patients with renal impairment: Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but administer with caution to patients with severe renal impairment (GFR<30ml/min). Patients with hepatic impairment: Plasma concentrations of felodipine may increase in patients with hepatic impairment, and they may respond to treatment at lower doses. Therefore, administer with caution to patients with hepatic impairment, including consideration of an initial dose of 2.5mg once daily, and do not administer to patients with severe hepatic impairment.

Child dose

The safety and efficacy of this medicine in children have not been established.

This medication should not be used in women who are pregnant or may become pregnant. Patients with severely impaired cardiac function or serious liver dysfunction should also avoid this medication. Caution is needed in cases of heart problems or certain valvular diseases. Since this medication lowers blood pressure, patients with excessively low blood pressure or weak cardiac function should use it carefully. Elderly patients or those with severe kidney dysfunction should also be cautious when taking it. When starting this medication or increasing the dosage, symptoms such as facial flushing, headache, palpitations, dizziness, and fatigue may appear. These symptoms are mostly temporary and can vary depending on the dosage. Due to its blood pressure-lowering effect, it may sometimes cause ankle swelling, chest tightness, or shortness of breath. Rarely, excessively low blood pressure, arrhythmia, headache, dizziness, nausea, constipation, oral inflammation, liver dysfunction, skin rash, etc., may occur. Abruptly discontinuing this medication can worsen symptoms, so the dosage should be gradually reduced under medical guidance. Dizziness may occur during use; it is advisable to avoid driving or operating hazardous machinery. This medication is recommended to be taken on an empty stomach or after a light meal in the morning. It may interact with other drugs, especially antihypertensives, antibiotics, antifungals, anticonvulsants, and grapefruit juice. It is safest for pregnant or breastfeeding women not to take this medication; in unavoidable cases, breastfeeding should be stopped. The safety for children has not been established, so it is advisable not to use it in children. The elderly should start with a lower dosage and use it cautiously while monitoring their condition. In case of overdose, symptoms such as decreased blood pressure, heart rhythm abnormalities, and consciousness disturbances may occur, and immediate medical attention is required. If experiencing dizziness or fatigue during use, caution is advised when driving or operating machinery.

• Facial flushing
• headache
• palpitations
• dizziness
• fatigue
• tachycardia
• feeling of suffocation
• chest tightness
• ankle swelling
• angina

This medication is sensitive to light, so it should be stored in a tightly sealed container that protects it from light. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

For domestic use: 30 tablets/bottle, 100 tablets/bottle; for export: 100 tablets (10 tablets/PTP x 10)