Medication info
Telmisartan/Amlodipine 40/10mg

Telmisartan/Amlodipine 40/10mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
White or whitish rectangular tablet
Packaging
30 tablets (10 tablets/Alu-Alu * 3), 30 tablets/bottle
Approval status
Active

MFDS item code 201606377 · Approved 2016.10.31 · Insurance code 665002190

Summary

Main use
Improvement in blood pressure control with the combination of amlodipine or telmisartan for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is one tablet once daily, to be taken with water regardless of meals. It is preferable to take it at the same time every day (e.g., in the morning). For patients with renal impairment, dosage adjustments are not necessary for mild to moderate renal impairment, but for severe renal impairment, treatment should start at a lower dose and be gradually increased. For patients with hepatic impairment, the daily dosage of telmisartan should not exceed 40 milligrams for mild or moderate hepatic impairment.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, so administration of this medication is not recommended.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Improvement in blood pressure control with the combination of amlodipine or telmisartan for essential hypertension

  • Essential hypertension
View approved original text

This medication effectively manages blood pressure through combination therapy for patients with essential hypertension who have difficulty controlling blood pressure with monotherapy using either amlodipine or telmisartan.

How to take

Adult dose

The recommended dosage for this medication is one tablet once daily, to be taken with water regardless of meals. It is preferable to take it at the same time every day (e.g., in the morning). For patients with renal impairment, dosage adjustments are not necessary for mild to moderate renal impairment, but for severe renal impairment, treatment should start at a lower dose and be gradually increased. For patients with hepatic impairment, the daily dosage of telmisartan should not exceed 40 milligrams for mild or moderate hepatic impairment.

Child dose

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

Precautions

This medication can cause serious harm to the fetus during pregnancy, especially in the second and third trimesters, and should not be used during pregnancy. If pregnancy is confirmed, this medication should be discontinued immediately. It is contraindicated in individuals with allergies to this medication or similar compounds, women who are pregnant or may become pregnant, nursing women, patients with cholestatic disease, severe hepatic impairment, certain heart conditions, severe hypotension, patients in shock, patients unstable after acute myocardial infarction, those with genetic issues related to the excipients of this medication, and those with diabetes or severe kidney disease. It should be administered cautiously in certain patients, including those with primary aldosteronism, specific heart valve diseases, liver impairments, gastrointestinal diseases, renal artery hypertension, patients on dialysis, the elderly, and patients taking other medications that affect the renin-angiotensin-aldosterone system. Dizziness and peripheral edema are commonly observed when taking this medication, and rare side effects such as severe fainting may also occur, thus requiring caution. This medication should not be initiated or continued during pregnancy, and if planning for pregnancy or confirmation of pregnancy occurs, it should be replaced with other antihypertensive treatments proven to be safe. Due to the risk of hypotension, careful monitoring is especially necessary in patients who are volume-depleted or have insufficient salt intake, and regular checks of serum potassium levels are necessary due to the risk of hyperkalemia. In patients with impaired kidney function, regular monitoring of renal function is required, and caution is warranted as symptoms may worsen in patients with myocardial infarction or angina. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating hazardous machinery. Interactions may occur when taken with other medications, especially digoxin, lithium, warfarin, non-steroidal anti-inflammatory drugs, simvastatin, and tacrolimus, so consultation with a specialist and periodic monitoring is necessary. It is recommended to avoid taking this medication while nursing. The safety and efficacy in patients under 18 years of age have not been well established, and therefore its use is not recommended. When administered to the elderly, careful observation and dosage adjustment are necessary as sensitive reactions may occur. In cases of overdose, symptoms such as hypotension, tachycardia, dizziness, and acute kidney failure may appear, requiring immediate contact with medical institutions for appropriate treatment. This medication should be kept out of reach of children and should be taken out of its sealed packaging immediately before administration.

Side effects and when to seek care immediately

Serious side effects

Severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever), liver issues (yellowing of skin or eyes, extreme fatigue), severe neurological symptoms (sudden and

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infections
  • urinary tract infections
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • sensory disturbances
  • taste disturbances
  • tremor
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • gingival enlargement
  • itching
  • sweating
  • rash
  • hair loss

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

Storage

This medication should be stored in a tightly sealed container that protects it from light, ideally at a temperature between 1°C and 30°C. Storing it this way maintains its efficacy and prevents degradation.

Appearance and packaging

Appearance

White or whitish rectangular tablet

Package unit

30 tablets (10 tablets/Alu-Alu * 3), 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.