Medication info

Pelodic Extended Release 5 mg (Felodipine)

Prescription medicationTabletOralExpired
Ingredient · strength
Felodipine›5mg / 1 tablet
Manufacturer / importer
IKSU Pharmaceutical Co., Ltd.
Appearance
Pink round film-coated tablets
Packaging
Packaging unit - 30 tablets/bottle, Packaging unit - 100 tablets/bottle, Packaging unit - 500 tablets/bottle
Approval status
Expired

MFDS item code 201906837 · Approved 2019.09.26

This product's status changed to Expired on 2024.09.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension and stable angina
Who takes it
Adults · Children
Adult dose
Swallow this medicine whole with water. Do not divide, chew, or crush it. 1. Hypertension The initial dose of felodipine is 5㎎ once daily, and the maintenance dose is 5-10㎎ once daily, taken orally in the morning. Do not exceed the maximum daily dose of 20㎎. This medicine may be administered concomitantly with a β-blocker or diuretic. If other antihypertensive agents are unsuitable, it may be administered as monotherapy. Adjust the dose according to the patient's response to treatment. 2. Stable angina The initial dose is 5㎎ once daily and may be increased to 10㎎ as needed. This medicine may be administered concomitantly if a β-blocker does not provide adequate effect. Adjust the dose according to the patient's response to treatment. 3. Elderly patients Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5㎎ once daily. 4. 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). 5. Patients with hepatic impairment The plasma concentration 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; consider an initial dose of 2.5mg once daily. This medicine must not be administered to patients with severe hepatic impairment.
Child dose
The safety and efficacy of this medicine in children have not been established.

Ingredients

Manufacturer
IKSU Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hypertension and stable angina

  • Hypertension
  • stable angina
View approved original text

This medication is primarily used to treat hypertension and stable angina.

How to take

Adult dose

Swallow this medicine whole with water. Do not divide, chew, or crush it. 1. Hypertension The initial dose of felodipine is 5㎎ once daily, and the maintenance dose is 5-10㎎ once daily, taken orally in the morning. Do not exceed the maximum daily dose of 20㎎. This medicine may be administered concomitantly with a β-blocker or diuretic. If other antihypertensive agents are unsuitable, it may be administered as monotherapy. Adjust the dose according to the patient's response to treatment. 2. Stable angina The initial dose is 5㎎ once daily and may be increased to 10㎎ as needed. This medicine may be administered concomitantly if a β-blocker does not provide adequate effect. Adjust the dose according to the patient's response to treatment. 3. Elderly patients Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5㎎ once daily. 4. 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). 5. Patients with hepatic impairment The plasma concentration 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; consider an initial dose of 2.5mg once daily. This medicine must not be administered to patients with severe hepatic impairment.

Child dose

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

Precautions

This drug should not be used by women who are pregnant or may become pregnant. It should also not be administered to patients with very weak heart function, acute myocardial infarction, or unstable angina. Patients who have had allergic reactions to this medication or have certain heart valve diseases should also avoid it. Patients with severe liver or kidney impairment should use this medication with caution. Elderly patients, those with excessively low blood pressure, and patients with heart failure should use this drug carefully and adjust the dosage according to the physician's instructions. When starting or increasing the dosage of this medication, symptoms like facial flushing, headaches, palpitations, dizziness, and fatigue may occur. These symptoms are mostly temporary and related to dosage. Other side effects like ankle swelling, skin rashes, itching, indigestion, and nausea may also occur, so consult a physician if unusual symptoms appear. Due to its blood pressure-lowering effect, discontinuing this medication suddenly may worsen symptoms, so the dosage should be reduced gradually. If blood pressure drops too low, dizziness may occur, so precautions should be taken when driving or operating dangerous machinery. It is recommended to take this medication in the morning, either on an empty stomach or after a light meal. Since it is metabolized in the liver, taking it with certain drugs may change its blood concentration. Particularly, taking it with grapefruit juice may enhance its effects, so it is advisable to avoid it. During pregnancy, it should not be used as it may affect the fetus, and while breastfeeding, it should be avoided if possible, or breastfeeding should be discontinued. Safety for use in children has not been established and there is limited experience with it. In case of overdose, severe hypotension, heart rhythm abnormalities, and consciousness disturbances may occur, requiring immediate emergency treatment. Caution is advised when driving or operating machinery as dizziness or fatigue may occur.

Side effects

Facial flushing, headache, palpitations, dizziness, fatigue, tachycardia, feeling of suffocation, chest tightness, ankle swelling, hypotension accompanied by tachycardia causing angina, extrasystoles, heaviness in the head, dizziness, staggering, lethargy, drowsiness, anxiety, sensory disturbances, syncope, nausea, constipation, discomfort in the stomach, heartburn, abdominal pain, loss of appetite, diarrhea, thirst, vomiting, gingival hypertrophy, gingivitis, elevated AST, elevated ALT, elevated ALP, elevated LDH, elevated BUN, elevated creatinine, anemia, rash, itching, exfoliative dermatitis, skin erythema, urticaria, photosensitivity reactions, vascular edema, leukocytoclastic vasculitis, myalgia, arthralgia, hyperglycemia, weight gain, peripheral edema, leg cramps, shoulder stiffness, weakness, tremors of the fingers, cough, sore throat, sweating, tearing, conjunctival injection, paresthesia, elevated CPK, elevated total cholesterol, elevated triglycerides, decreased serum potassium, gynecomastia, erectile dysfunction, sexual dysfunction, frequent urination, angioedema, fever, confusion, sleep disorders, hypothermia, nausea

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container that can block light, at a temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

Packaging unit - 30 tablets/bottle, Packaging unit - 100 tablets/bottle, Packaging unit - 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.