Medication info
Telmisartan/Amlodipine 40/5 mg

Telmisartan/Amlodipine 40/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Biconvex oval dual tablet in white and light blue color
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 202002376 · Approved 2020.04.05 · Insurance code 054800900

Summary

Main use
Improvement of blood pressure in essential hypertension not controlled by monotherapy with telmisartan or amlodipine
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet taken once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). In cases of severe kidney impairment, treatment should start at a lower dose, and the dose should be gradually increased. For patients with liver impairment, the daily dose of telmisartan should not exceed 40 mg. Elderly patients (75 years or older) should start with a lower dose.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Improvement of blood pressure in essential hypertension not controlled by monotherapy with telmisartan or amlodipine

  • Essential hypertension
View approved original text

This medicine is used in patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy of telmisartan or amlodipine. Hypertension is a persistent high blood pressure condition that increases the risk of cardiovascular disease, making proper blood pressure control crucial. This medication effectively lowers blood pressure, improving heart and vascular health. It is a therapeutic agent that helps to stably manage blood pressure according to the patient's condition.

How to take

Adult dose

The recommended dose of this medication is 1 tablet taken once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). In cases of severe kidney impairment, treatment should start at a lower dose, and the dose should be gradually increased. For patients with liver impairment, the daily dose of telmisartan should not exceed 40 mg. Elderly patients (75 years or older) should start with a lower dose.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Precautions

This drug can cause serious health issues to the fetus or newborn when taken during pregnancy, especially in the second and third trimesters, and therefore should not be taken by women who are pregnant or may become pregnant. This drug should not be administered to patients with specific diseases, such as those with severe liver or heart problems, severe hypotension, and certain genetic disorders. Patients with primary aldosteronism, heart valve disease, liver dysfunction, gastrointestinal disorders, kidney disease, the elderly, and others need special caution when using this drug. Common side effects such as dizziness or swelling may occur while taking this drug, and serious side effects can occur rarely; therefore, if any unusual symptoms arise, consult a healthcare professional immediately. This drug should not be used during pregnancy, and if pregnancy is confirmed, treatment should be discontinued as soon as possible, and alternative therapy should be sought. Hypotension may occur, so patients who are deficient in fluid or salt should adjust their condition before taking this drug and monitor their status carefully during treatment. Since there is a risk of elevated potassium levels in the blood, caution is needed if supplementing with potassium or taking medications containing potassium. Patients with decreased kidney function should have their kidney function and serum electrolyte levels monitored regularly while taking this drug. Patients with heart disease should be cautious as this drug may worsen symptoms of myocardial infarction or angina. This drug may cause drowsiness or dizziness, so extra care should be taken while driving or operating hazardous machinery during treatment. This drug may interact with other medications, so if you are taking any other medications, be sure to inform your healthcare provider. The elderly may be more sensitive to this drug, so it is safer to start at a lower dose and gradually increase. In cases of overdose, symptoms such as decreased blood pressure, dizziness, and abnormal heart rhythms may occur, and appropriate treatment should be sought immediately at a medical facility. This drug is not recommended for children as its safety and efficacy have not been established in this population. Store this medication away from children, and open the packaging immediately before taking.

Side effects and when to seek care immediately

Serious side effects

Severe swelling (angioedema), hives, difficulty breathing, interstitial lung disease, hepatitis, jaundice, myocardial infarction, ventricular tachycardia, arrhythmia, atrial fibrillation, vasculitis, sepsis, anaphylactic reaction, syncope, Stevens-Johnson syndrome, photosensitivity reaction, toxic epidermal necrolysis, renal impairment (including acute renal failure), congestive heart failure, cerebral infarction, intestinal vascular edema

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • mood changes
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • headache
  • paresthesia
  • dysgeusia
  • tremors
  • visual impairment
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • indigestion
  • nausea
  • vomiting
  • dry mouth
  • liver dysfunction
  • liver impairment
  • itching

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 container that protects against light and kept at room temperature between 1 and 30 degrees Celsius. Therefore, it is important to avoid direct sunlight and not to store it in excessively hot or cold places.

Appearance and packaging

Appearance

Biconvex oval dual tablet in white and light blue color

Package unit

30 tablets (10 tablets/PTP x 3)

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.