Medication info
Telmisartan and Amlodipine Tablets 40/5 mg

Telmisartan and Amlodipine Tablets 40/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
제일헬스사이언스(주)
Appearance
White oval biconvex tablet
Packaging
30 tablets (10 tablets/PTP X 3), 30 tablets/bottle
Approval status
Active

MFDS item code 201907043 · Approved 2019.10.04 · Insurance code 054301130

Summary

Main use
Improvement of essential hypertension blood pressure control with the combination of Amlodipine or Telmisartan
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is 1 tablet once daily, 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: no dose adjustment is needed for mild to moderate renal impairment; however, for severe renal impairment, treatment should begin at a lower dose, with a gradual increase in dosage. For patients with hepatic impairment: for mild or moderate hepatic impairment, the daily dose of Telmisartan should not exceed 40 mg.
Child dose
The safety and efficacy in pediatric patients under the age of 18 have not been established, and thus the administration of this medication is not recommended.

Ingredients

Manufacturer
제일헬스사이언스(주)

Efficacy & effects

Improvement of essential hypertension blood pressure control with the combination of Amlodipine or Telmisartan

  • Essential hypertension
View approved original text

This medication is used to effectively control blood pressure in patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with Amlodipine or Telmisartan.

How to take

Adult dose

The recommended dose for this medication is 1 tablet once daily, 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: no dose adjustment is needed for mild to moderate renal impairment; however, for severe renal impairment, treatment should begin at a lower dose, with a gradual increase in dosage. For patients with hepatic impairment: for mild or moderate hepatic impairment, the daily dose of Telmisartan should not exceed 40 mg.

Child dose

The safety and efficacy in pediatric patients under the age of 18 have not been established, and thus the administration of this medication is not recommended.

Precautions

This drug should not be used during pregnancy, especially in the second and third trimesters, as it can pose serious risks to the fetus. If pregnancy is confirmed, this medication should be discontinued as soon as possible. This drug is contraindicated in persons allergic to the active substance or any excipients, women who are pregnant or may become pregnant, nursing mothers, and patients with severe liver or biliary disease. Patients with significant heart problems or low blood pressure, and those in an unstable condition after acute myocardial infarction, should also not take this medication. Patients with certain heart diseases or liver function disorders, gastrointestinal diseases, renal vascular problems, those undergoing dialysis, and the elderly should use this drug with caution. While taking this medication, side effects such as dizziness or edema may occur, and serious side effects may infrequently arise, so caution is required. During treatment, blood pressure may drop too low, leading to issues such as hyperkalemia or renal function abnormalities; thus, regular monitoring is necessary. This medication may interact with other drugs, so it is important to inform healthcare professionals if you are taking other medications. Pregnant or nursing women should not take this medication, and if planning a pregnancy, it is advisable to switch to a safer antihypertensive drug. The safety and efficacy in children have not been established, so this drug is not recommended for them. In case of overdose, symptoms such as hypotension, dizziness, and cardiac arrhythmias may occur, requiring immediate medical attention. This medication should be kept out of reach of children, and it is important to store it sealed until just prior to administration.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory failure with cough and fever, respiratory issues, jaundice, yellowing of the skin or eyes, severe systemic malaise, liver abnormalities, sudden and severe reactions

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • headache
  • paresthesia
  • tremor
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • pruritus
  • hyperhidrosis
  • rash
  • alopecia
  • purpura
  • skin changes

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 tightly closed container that blocks light. It is advisable to store it at room temperature between 1 to 30 degrees Celsius to maintain its efficacy and safety.

Appearance and packaging

Appearance

White oval biconvex tablet

Package unit

30 tablets (10 tablets/PTP X 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.