Girodipine Sustained Release (Felodipine)

Adult dose

Swallow this medicine whole with water; do not divide, chew, or crush it. 1. Hypertension For felodipine, administer an initial dose of 5㎎ orally once daily in the morning, and a maintenance dose of 5-10㎎ per day. Do not exceed the maximum daily dose of 20㎎. This medicine may be coadministered with a β-blocker or diuretic, or used as monotherapy when other antihypertensive medicines are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina Administer an initial dose of 5㎎ once daily; the dose may be increased to 10㎎ if necessary. This medicine may be coadministered when an adequate effect is not achieved with a β-blocker. Adjust the dose according to the patient's response to treatment. 3. Older adults Consider administering an initial dose of 2.5㎎ once daily and use with caution while monitoring the patient's condition. 4. Patients with renal impairment Renal impairment does not affect felodipine plasma concentrations. No dose adjustment is necessary, but use with caution in patients with severe renal impairment (GFR<30ml/min). 5. Patients with hepatic impairment Felodipine plasma concentrations may increase in patients with hepatic impairment, and they may respond to treatment at lower doses. Therefore, use with caution in patients with hepatic impairment, considering an initial dose of 2.5㎎ once daily; do not administer to patients with severe hepatic impairment.

Child dose

The safety and efficacy in children have not been established.

This medicine should not be used by women who are pregnant or may become pregnant. It should also not be administered to patients with cardiogenic shock, severely impaired cardiac function, or severely compromised liver or kidney function. Patients with aortic or mitral valve stenosis, who are at risk of excessively low blood pressure, should also refrain from using this medication. Patients who have had an allergic reaction to this drug should avoid administration. It should be used cautiously in elderly patients or those with heart failure, hypotension, or liver dysfunction, especially those with severe kidney impairment. Patients with allergies or genetic issues related to the dyes or lactose contained in this medication should also be careful. When starting this medication or increasing the dose, side effects such as facial flushing, headaches, rapid heartbeat, dizziness, and fatigue may occur. These symptoms are usually temporary and dose-related. Rarely, palpitations, shortness of breath, chest tightness, ankle swelling, hypotension, and abnormal heart rhythms may occur. Gastrointestinal symptoms like headaches, dizziness, drowsiness, malaise, nausea, constipation, loss of appetite, diarrhea, and vomiting may also arise. Gingivitis or gingival hyperplasia has also been reported, so oral hygiene should be maintained. Regular check-ups are needed as liver function tests may increase or kidney function indicators may change. Allergic reactions such as skin rash, itching, and urticaria may occur, so if these symptoms appear, use should be discontinued immediately. Muscle pain, joint pain, elevated blood glucose, weight gain, peripheral edema, and sexual dysfunction have also been reported rarely. Abrupt discontinuation of this medication can worsen symptoms, so the dosage should be reduced slowly as directed by a physician, and caution should be taken to avoid stopping it arbitrarily. If blood pressure becomes too low, the dose may be reduced or administration stopped. Dizziness may occur upon intake, so it is advisable to avoid heights, driving, or operating dangerous machinery. It is preferable to take this medication on an empty stomach or after a light meal in the morning. This medication is metabolized by the enzyme CYP3A4 in the liver, so caution is needed when used in combination with drugs that inhibit or promote this enzyme. It may particularly interact with certain antibiotics, antifungals, antivirals, gastrointestinal medications, and anticonvulsants, so consultation with a doctor or pharmacist is advised. Grapefruit juice should be avoided, as it may increase drug concentrations. Safety has not been established during pregnancy, so pregnant women should not use it, and breastfeeding should be avoided or discontinued during treatment. Safety and efficacy have not been established for children, so it is best not to use it in pediatric patients. Elderly patients have a risk of excessively low blood pressure, so they should start with a low dose and be administered cautiously. In cases of overdose, severe symptoms such as low blood pressure, heart arrhythmias, altered consciousness, and seizures may occur, so immediate medical attention is required. Dizziness or fatigue may arise during treatment, so caution should be taken when driving or operating machinery.

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

This medication should be stored in a tightly sealed container that can block light, at room temperature between 1 degree and 30 degrees Celsius. Storing it this way can maintain its efficacy and prevent deterioration.

Appearance

Pink round film-coated tablet

Package unit

Domestic: 30 tablets/bottle, 100 tablets/bottle Export: 30 tablets (10 tablets/PTP*3), 100 tablets (10 tablets/PTP*10)