Medication info
Bielnovas Tablet 5 mg (Amlodipine Besilate)

Bielnovas Tablet 5 mg (Amlodipine Besilate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
(주)씨엘팜
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201900229 · Approved 2019.01.17 · Insurance code 622600530

Summary

Main use
Effectiveness in treating myocardial ischemia caused by hypertension and stable or variant angina, and reducing the risk of hospitalization due to angina and the risks associated with vascular reconstruction.
Who takes it
Adults
Adult dose
Adults: Administer 5 mg orally once daily as amlodipine, and may increase up to 10 mg daily based on the patient's response. Adjust accordingly based on age and symptoms.

Ingredients

Manufacturer
(주)씨엘팜

Efficacy & effects

Effectiveness in treating myocardial ischemia caused by hypertension and stable or variant angina, and reducing the risk of hospitalization due to angina and the risks associated with vascular reconstruction.

  • Hypertension
  • fixed obstruction of coronary artery
  • vascular spasm
  • vasoconstriction
  • myocardial ischemia
  • angina
View approved original text

This medication is used in the treatment of hypertension and myocardial ischemia resulting from stable and variant angina. It also helps reduce the risk of hospitalization due to angina in patients with confirmed coronary artery disease without heart failure, or in those with an ejection fraction of 40% or more, as well as the risks associated with coronary angioplasty. Therefore, it is used to improve cardiovascular health and effectively manage angina symptoms.

How to take

Adult dose

Adults: Administer 5 mg orally once daily as amlodipine, and may increase up to 10 mg daily based on the patient's response. Adjust accordingly based on age and symptoms.

Precautions

This drug is not safe for use in certain patients. For example, it is contraindicated in patients who have had an allergic reaction to this medication or similar medications, nursing women, patients with severe liver dysfunction, severe aortic stenosis patients, and patients in shock. Additionally, caution is advised when administering this drug to patients with severe hypotension, those requiring dialysis due to renal failure, elderly patients, and women who are pregnant or may become pregnant. Taking this drug may cause side effects such as facial flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, various adverse reactions such as decreased blood pressure, allergic reactions, skin rash, myalgia, and dyspepsia have been reported. Patients with heart failure or liver impairment should carefully monitor the effects and side effects of this drug while taking it. Furthermore, this drug lowers blood pressure gradually, so it is not suitable for emergency situations such as acute angina. Generally, this drug does not significantly impact the ability to drive or operate machinery, but individual responses may vary, necessitating caution. When taken with other medications, interactions may occur, so caution is especially needed when used in conjunction with grapefruit juice, certain antibiotics, antihypertensives, and immunosuppressants. Women who are pregnant or nursing should consult a doctor before taking this medication, and it is recommended to avoid taking this drug while breastfeeding. The use in children is only recommended for those aged 6 years and older, as safety and effectiveness have not been established for younger ages. In case of overdose, blood pressure may drop too low, and the heart may race or enter a state of shock, requiring immediate medical assistance, and emergency treatments such as gastric lavage or administration of activated charcoal may be necessary.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • yellowing of the skin or eyes (jaundice)
  • severe drowsiness
  • toxic epidermal necrolysis

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • low blood pressure
  • vasculitis
  • tension
  • sensory loss/sensory abnormalities
  • peripheral neuropathy
  • fainting
  • taste abnormalities
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • lumbago
  • muscle cramps
  • myalgia

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White octagonal tablet

Package unit

30 tablets/bottle, 300 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.