Medication info

Telmisartan/Esamlodipine Tablets 80/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletS-Amlodipine Besylate Dihydrate›7.38mg / 1 tablet
Manufacturer / importer
(주)비씨월드헬스케어
Appearance
Pale yellow and pale blue bi-layered oblong tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202203404 · Approved 2022.08.26

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Patients with renal impairment do not require dosage adjustment for mild to moderate renal impairment, but patients with severe renal impairment should start with a lower dose and gradually increase it. The daily dose for patients with liver impairment should not exceed 40 mg.
Child dose
Safety and efficacy in pediatric patients under the age of 18 have not been established, so the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)비씨월드헬스케어

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication effectively lowers blood pressure in patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with telmisartan or esamlodipine (amlodipine). It helps control blood pressure by dilating blood vessels and reducing cardiac workload. Consequently, it decreases the risk of cardiovascular complications and contributes to the overall health of patients. Therefore, this medication is used for the treatment of essential hypertension.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Patients with renal impairment do not require dosage adjustment for mild to moderate renal impairment, but patients with severe renal impairment should start with a lower dose and gradually increase it. The daily dose for patients with liver impairment should not exceed 40 mg.

Child dose

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

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus and newborn. If pregnancy is confirmed, this medication should be discontinued immediately, and alternative treatment methods should be sought. This medication should not be administered to patients with allergies to its active ingredients or related compounds, those with certain liver, heart, or kidney diseases, pregnant or nursing women, and patients with certain other conditions. Special caution is advised when using this medication in patients with specific heart valve diseases, impaired liver function, gastrointestinal diseases, kidney diseases, the elderly, etc., and it should be taken cautiously under the direction of a physician. While taking this medication, side effects such as headache, dizziness, edema, palpitations, gastrointestinal disturbances may occur, and if any abnormal symptoms appear, immediate consultation with medical personnel is required. Taking this medication during pregnancy can result in serious issues such as reduced fetal kidney function, decreased amniotic fluid, and skull formation disorders, so if planning pregnancy or already pregnant, it is essential to consult with a doctor. In nursing mothers, this medication may be transmitted through breast milk, so nursing should be discontinued or this medication should be avoided. It is not recommended for children as safety and efficacy have not been sufficiently established. When administered to the elderly, the dosage should be adjusted and carefully monitored as physical reactions may be more sensitive. In cases of overdose, severe hypotension, dizziness, and arrhythmias may occur, and it is necessary to visit a medical institution immediately for appropriate treatment. This medication may interact with other drugs, so if you are taking any other medications, be sure to inform your healthcare provider. Caution should be exercised as dizziness or drowsiness may occur when driving or operating machinery. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Severe allergic reactions: Angioedema (could result in fatal outcomes)
  • Severe skin adverse reactions: Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
  • Respiratory issues: Asthma, shortness of breath
  • Liver issues (jaundice): Yellowing of skin or eyes (jaundice), liver dysfunction and liver disease, increased jaundice and liver enzyme levels
  • Severe neurological symptoms: Seizures, confusion
  • Severe swelling or urination issues: Angioedema, decreased urine output

Mild side effects

  • Headache
  • peripheral edema
  • swelling
  • palpitations
  • dizziness
  • increased SGOT
  • nausea
  • increased platelets
  • facial flushing
  • local edema
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  • orthostatic hypotension
  • low back pain
  • upper respiratory infection
  • sinusitis
  • diarrhea
  • pharyngitis
  • influenza-like symptoms
  • dyspepsia
  • myalgia
  • urinary tract infection
  • abdominal pain
  • dizziness
  • pain
  • fatigue
  • cough
  • hypertension
  • chest pain
  • nausea
  • erectile dysfunction
  • increased sweating
  • flushing
  • fever
  • leg pain
  • lethargy
  • palpitations

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is recommended to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow and pale blue bi-layered oblong tablets

Package unit

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.