Medication info
Binex Pelodipine Tablet

Binex Pelodipine Tablet

Prescription medicationTabletOral
Ingredient · strength
Felodipine›5mg / 1 tablet
Manufacturer / importer
Binex Co., Ltd.
Appearance
Light pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200400538 · Notified 2004.08.09 · Insurance code 643100790

Summary

Main use
Treatment of hypertension and stable angina
Who takes it
Adults · Children
Adult dose
This medicine should be swallowed whole with water. Do not split, chew, or crush it before taking it. 1. Hypertension The initial dose of felodipine is 5 mg once daily, and the maintenance dose is 5-10 mg once daily, administered orally in the morning. Do not exceed the maximum daily dose of 20 mg. This medicine may be administered in combination with a β-blocker or diuretic, and may be administered as monotherapy if other antihypertensive agents are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina The initial dose is 5 mg once daily, which may be increased to 10 mg if needed. This medicine may be administered in combination with a β-blocker if it does not provide sufficient effect. Adjust the dose according to the patient's response to treatment. 3. Older adults Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5 mg once daily. 4. Patients with renal impairment Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but use with caution in 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 a lower dose. Therefore, administer with caution to patients with hepatic impairment; consider an initial dose of 2.5mg once daily. This medicine should 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
Binex Co., Ltd.

Efficacy & effects

Treatment of hypertension and stable angina

  • Hypertension
  • stable angina
View approved original text

This medication is used for hypertension and stable angina.

How to take

Adult dose

This medicine should be swallowed whole with water. Do not split, chew, or crush it before taking it. 1. Hypertension The initial dose of felodipine is 5 mg once daily, and the maintenance dose is 5-10 mg once daily, administered orally in the morning. Do not exceed the maximum daily dose of 20 mg. This medicine may be administered in combination with a β-blocker or diuretic, and may be administered as monotherapy if other antihypertensive agents are unsuitable. Adjust the dose according to the patient's response to treatment. 2. Stable angina The initial dose is 5 mg once daily, which may be increased to 10 mg if needed. This medicine may be administered in combination with a β-blocker if it does not provide sufficient effect. Adjust the dose according to the patient's response to treatment. 3. Older adults Administer with caution while monitoring the patient's condition; consider an initial dose of 2.5 mg once daily. 4. Patients with renal impairment Renal impairment does not affect the plasma concentration of felodipine. Dose adjustment is not necessary, but use with caution in 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 a lower dose. Therefore, administer with caution to patients with hepatic impairment; consider an initial dose of 2.5mg once daily. This medicine should 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 medication should not be used in women who are pregnant or may become pregnant. It is also not safe for patients with cardiogenic shock, severe liver dysfunction, or certain cardiac valve diseases. Patients who have had allergic reactions or a history of hypersensitivity to this medication should avoid its use. Additionally, patients with certain genetic metabolic disorders, such as lactose intolerance, should not take this medication due to the lactose component. In elderly patients or those with heart failure, low blood pressure, or impaired liver or kidney function, this medication must be administered with caution, and care is needed as it contains additives that can cause allergic reactions. When taking this medication for the first time or increasing the dosage, side effects such as flushing, headache, palpitations, dizziness, and fatigue may occur. These symptoms are generally temporary and depend on the dosage. Cardiac-related side effects may include chest tightness and ankle swelling, and in rare cases, dangerous side effects related to low blood pressure may arise, so caution is necessary. Neurological symptoms such as headache, dizziness, drowsiness, and anxiety may also occur, and gastrointestinal issues such as nausea, constipation, abdominal pain, and decreased appetite have been reported. Oral hygiene should be maintained as this medication can also impact dental and gum health, and immediate consultation with healthcare professionals is necessary if signs of liver or kidney dysfunction occur. Allergic reactions such as rashes or itching, and rarely urticaria, may appear on the skin, so if these symptoms are observed, use should be discontinued, and a doctor should be notified. Various symptoms such as muscular pain, joint pain, increased blood sugar, and weight gain may also occur, so if there are any unusual symptoms, consult a healthcare professional. Abrupt discontinuation of this medication may worsen symptoms, so the dosage should be gradually reduced according to a doctor's instructions, and if blood pressure becomes too low, the dosage may need to be adjusted or stopped. There is a risk of accident due to dizziness or drowsiness while driving or operating machinery, so caution is advised. It is recommended to take this medication before meals or after a light meal, preferably in the morning. Due to many drug interactions, especially with antihypertensive drugs, antibiotics, antifungals, anticonvulsants, and grapefruit juice, it is essential to consult with healthcare professionals before taking them together. It is safest for women who are pregnant or breastfeeding not to use this medication, and if necessary, breastfeeding should be discontinued. Safety for children has not been established, so it is advisable not to use this medication in children. In elderly patients, treatment should start at a low dose and carefully observe the patient's condition. In cases of overdose, serious cardiovascular symptoms and neurological symptoms may occur, so immediate hospital treatment is required. During the use of this medication, dizziness or fatigue may occur, so driving or operating dangerous machinery should be avoided.

Side effects

  • Facial flushing
  • headache
  • palpitations
  • dizziness
  • fatigue
  • tachycardia
  • feeling of suffocation
  • chest tightness
  • ankle edema
  • tachycardia causing angina
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  • hypotension
  • extrasystoles
  • heaviness in the head
  • dizziness
  • staggering
  • lethargy
  • drowsiness
  • anxiety
  • sensory disturbances
  • syncope
  • nausea
  • constipation
  • gastric discomfort
  • heartburn
  • abdominal pain
  • loss of appetite
  • diarrhea
  • thirst
  • vomiting
  • gingival hypertrophy
  • gingivitis
  • increased AST
  • increased ALT
  • increased ALP
  • increased LDH
  • increased BUN
  • increased 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
  • tremor of fingers
  • cough
  • pharyngeal discomfort
  • sweating
  • tearing
  • conjunctival injection
  • paresthesia
  • increased CPK
  • increased total cholesterol
  • increased triglycerides
  • decreased serum potassium
  • gynecomastia
  • erectile dysfunction
  • sexual dysfunction
  • polyuria
  • angioedema
  • fever
  • confusion
  • sleep disturbances
  • mild toxicity symptoms
  • significantly lowered blood pressure
  • bradycardia
  • AV block I-III
  • AV dissociation
  • ventricular extrasystoles
  • ineffective contractions
  • impaired consciousness
  • coma
  • seizures
  • dyspnea
  • pulmonary edema
  • apnea
  • adult respiratory distress syndrome
  • acidosis
  • hypocalcemia
  • hypothermia
  • nausea

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

Storage

This medication should be stored in a tightly closed container that can block light and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

Light pink round film-coated tablet

Package unit

30 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.