Medication info
Novanel Tablet 5 mg (Amlodipine Besilate)

Novanel Tablet 5 mg (Amlodipine Besilate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
한국넬슨제약(주)
Appearance
Octagonal white tablet with NS engraved on the front and AB and 5 engraved on the back.
Packaging
300 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 201700906 · Approved 2017.02.21 · Insurance code 656701980

Summary

Main use
Effectiveness in improving myocardial ischemia due to hypertension and stable/variant angina as well as reducing the risk of hospitalization due to angina.
Who takes it
Adults
Adult dose
For adults, Amlodipine 5 mg is administered orally once daily, and it can be increased to a maximum of 10 mg daily depending on the patient's response. Adjust dosage based on age and symptoms.

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

Effectiveness in improving myocardial ischemia due to hypertension and stable/variant angina as well as reducing the risk of hospitalization due to angina.

  • Hypertension
  • fixed occlusion of coronary artery
  • coronary vasospasm
  • vasoconstriction
  • myocardial ischemia.
View approved original text

This medication is used to treat myocardial ischemia caused by hypertension and stable/variant angina. It also helps reduce the risk of hospitalization due to angina in patients with coronary artery disease confirmed by recent angiography who do not have heart failure or have a cardiac output of more than 40%. This medication is effective in improving heart health and preventing complications.

How to take

Adult dose

For adults, Amlodipine 5 mg is administered orally once daily, and it can be increased to a maximum of 10 mg daily depending on the patient's response. Adjust dosage based on age and symptoms.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to individuals with an allergy to this drug or similar types of medication, nursing women, patients with severe liver dysfunction, severe aortic stenosis, and those in a state of shock. There are cases where this medication should be used with caution. Special attention is needed in patients with severe hypotension, those requiring dialysis for renal failure, elderly patients, and women who are pregnant or may become pregnant. Side effects that may occur when taking this medication include flushing, fatigue, swelling, feelings of rapid heartbeat, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, reports have indicated that blood pressure may drop too low, neurological issues, gastrointestinal problems, skin rashes, and liver function abnormalities may occur. Patients with heart failure or impaired liver function need to be more cautious when taking this medication, as its effects may appear slowly and it is not suitable for acute heart problems. This medication may interact with other medications. Particularly, it is advised to avoid taking it with grapefruit juice as it may enhance drug effects. Additionally, when taken in combination with certain antibiotics or immunosuppressants, careful monitoring according to a physician’s guidance is necessary. Women who are pregnant or nursing should always consult their doctor before taking this medication, and nursing should be discontinued during the period of medication use if breastfeeding. In children, its use is recommended only for those aged 6 years and older, as safety and efficacy have not been established in children under 6. In case of overdose, blood pressure may drop too low, requiring immediate medical attention and close observation of heart and respiratory status. This medication is known not to significantly affect the ability to drive or operate machinery, but caution is advised as dizziness or drowsiness may occur depending on the individual.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • severe allergic reactions
  • liver abnormalities (jaundice)
  • jaundice
  • toxic epidermal necrolysis
  • severe skin adverse reactions
  • allergic reactions
  • angioedema.

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory loss/alteration
  • peripheral neuropathy
  • syncope
  • altered taste
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • indigestion
  • gingival hypertrophy
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myalgia

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

Storage

This medication is sensitive to light, so it should be stored in a well-protected container. Additionally, it is recommended to store it at a temperature between 1°C and 30°C at room temperature. Proper storage helps maintain the efficacy of the medication.

Appearance and packaging

Appearance

Octagonal white tablet with NS engraved on the front and AB and 5 engraved on the back.

Package unit

300 tablets/bottle, 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.