Medication info
Enpistar Tablets 40/5mg

Enpistar Tablets 40/5mg

Prescription medication경구
Ingredient · strength
Telmisartan Powder 23.9%›167.36mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
This is a biconvex, oval double tablet that is white and light gray.
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201605822 · Approved 2016.09.30 · Insurance code 669906990

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients with renal impairment, no dose adjustment is necessary for mild to moderate cases, but for severe renal impairment, it is advised to start with a lower dose and gradually increase. For patients with liver impairment, the daily dosage should not exceed 40 milligrams. Elderly patients (75 years old and over) should start treatment with smaller doses and increase gradually, and their condition monitored carefully.
Child dose
Safety and efficacy have not been established in patients under 18 years of age, so the use of this medication is not recommended.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively manage essential hypertension when blood pressure is not sufficiently controlled with telmisartan or amlodipine monotherapy.

How to take

Adult dose

The recommended dosage is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients with renal impairment, no dose adjustment is necessary for mild to moderate cases, but for severe renal impairment, it is advised to start with a lower dose and gradually increase. For patients with liver impairment, the daily dosage should not exceed 40 milligrams. Elderly patients (75 years old and over) should start treatment with smaller doses and increase gradually, and their condition monitored carefully.

Child dose

Safety and efficacy have not been established in patients under 18 years of age, so the use of this medication is not recommended.

Precautions

This drug may pose serious risks to the fetus or newborn during pregnancy, especially in the second and third trimesters, and should not be taken by women who are pregnant or may become pregnant. People allergic to the active ingredients or similar substances, those with severe liver impairment, hypotension, or heart function issues should not take this medication. Patients with impaired liver or kidney function, the elderly, or patients with certain heart diseases should use this drug more cautiously and be monitored carefully according to a physician's instructions. When taking this medication, side effects such as dizziness, swelling, or hypotension may occur; if symptoms are severe, immediate consultation with a healthcare professional is necessary. It is crucial to monitor blood pressure and heart conditions regularly during treatment, especially since the medication can lower blood pressure too much or cause heart problems. This drug may interact with other medications, so inform your doctor or pharmacist about any current medications you are taking. Women who are pregnant or breastfeeding should not take this medication and should stop taking it immediately and consult a physician if pregnancy is planned or confirmed. The safety and efficacy have not been established for use in children, so its use is not recommended in this age group. In case of overdose, there is a risk of hypotension, dizziness, or heart function decline, requiring immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions (urticaria, angioedema), severe skin reactions (angioedema, urticaria, Stevens-Johnson syndrome), respiratory issues (dyspnea), liver abnormalities (jaundice), severe neurological symptoms (syncope), severe edema or urination abnormalities (kidney dysfunction, acute renal failure), sepsis, leukopenia, thrombocytopenia, anaphylactic reactions, myocardial infarction, ventricular tachycardia, arrhythmias, atrial fibrillation, vasculitis, hepatitis, jaundice, liver dysfunction.

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • depression
  • insomnia
  • anxiety
  • drowsiness
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  • headache
  • sensory disturbance
  • fainting
  • visual impairment
  • dizziness
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • liver function abnormalities
  • liver impairment
  • itching
  • rash
  • hair loss
  • eczema
  • erythema
  • angioedema
  • urticaria
  • joint swelling
  • muscle cramps

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

Storage

This medication is sensitive to light and should be stored in a special container that does not allow light in. Additionally, it should be stored at room temperature, between 1 to 30 degrees Celsius, away from extremes of heat or cold to maintain effectiveness.

Appearance and packaging

Appearance

This is a biconvex, oval double tablet that is white and light gray.

Package unit

30 tablets (10 tablets/PTPX3)

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

No questions yet.

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.