Medication info
Telmidipine Tablets 80/5/5 mg (Telmisartan, Amlodipine, Rosuvastatin)

Telmidipine Tablets 80/5/5 mg (Telmisartan, Amlodipine, Rosuvastatin)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets / bottle
Approval status
Active

MFDS item code 202500492 · Approved 2025.03.05 · Insurance code 657808360

Summary

Main use
(Hypertension, Hypercholesterolemia) Effect on blood pressure control and cholesterol improvement, reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
Take one tablet once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For the Telmisartan/Amlodipine combination, dose adjustments are necessary based on blood pressure control, with common dosages of 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg. The initial dose of Rosuvastatin is 5 mg once daily.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

(Hypertension, Hypercholesterolemia) Effect on blood pressure control and cholesterol improvement, reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factor
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used for patients with essential hypertension who are not adequately controlled with the combination of Telmisartan and Amlodipine, as well as for patients with hyperlipidemia requiring Rosuvastatin Calcium. The Telmisartan/Amlodipine combination aids in effectively lowering blood pressure. Rosuvastatin is utilized as an adjunct in various lipid disorders such as primary hypercholesterolemia or mixed dyslipidemia when dietary changes and exercise are insufficient, and it also applies to heterozygous familial hypercholesterolemia and dysbetalipoproteinemia. Furthermore, it helps lower cholesterol levels in patients with hypercholesterolemia, delays the progression of atherosclerosis, and reduces the risk of stroke, myocardial infarction, and revascularization surgeries in high-risk cardiovascular disease patients with elevated high-sensitivity C-reactive protein levels. Therefore, this medication is effective for controlling blood pressure and preventing cardiovascular diseases.

How to take

Adult dose

Take one tablet once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For the Telmisartan/Amlodipine combination, dose adjustments are necessary based on blood pressure control, with common dosages of 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg. The initial dose of Rosuvastatin is 5 mg once daily.

Precautions

This medication can cause serious harm to the fetus and newborn if administered to pregnant women, so its use must be discontinued immediately upon confirmation of pregnancy. Patients allergic to any of the active ingredients or related components, those with certain hereditary angioedema, and patients with severe liver or kidney dysfunction should not take this medication. Elderly patients, those with hypotension, compromised liver function, and patients with high serum potassium levels must use this medication cautiously and may require regular check-ups as necessary. If symptoms such as muscle pain, weakness, or cramps occur during treatment, consult a doctor immediately, and muscle enzyme tests may be necessary. This medication may affect liver function; therefore, it is important to periodically conduct liver function tests before and during treatment. Interactions may occur when taken with other medications, so inform healthcare professionals of any other medications being taken. This medication is not recommended for breastfeeding women, and if it must be taken, breastfeeding should be discontinued. In case of overdose, severe hypotension, dizziness, or arrhythmias may occur; seek medical attention immediately. It is not recommended for use in children and adolescents under 18, as safety and effectiveness have not been sufficiently confirmed. Store this medication out of reach of children and avoid transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Angioedema, severe swelling (edema), difficulty breathing, asthma, vascular swelling, dyspnea, jaundice, liver dysfunction, sudden and very severe headache, seizures, confusion, visual disturbances, paralysis, significant reduction in urine output, severe generalized edema with elevated blood pressure, anaphylaxis, thrombocytopenia, acute renal failure, rhabdomyolysis, Stevens-Johnson syndrome, severe cutaneous adverse reactions, toxic epidermal necrolysis.

Mild side effects

Headache, dizziness, weakness, cough, nausea, fatigue, malaise, lower limb edema, angioedema, itching, increased sweating, erythema, chest pain, atrial fibrillation, congestive heart failure, worsened hypertension, hypotension (including orthostatic hypotension), diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps, myalgia, bradycardia, thrombocytopenia, increased uric acid, halitosis, fatty liver, chronic gastritis, hiatal hernia, sensory disturbances, movement disorders

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

Storage

This medication should be stored in a tightly sealed container that blocks light, safely kept at a temperature between 1°C and 30°C. This storage method will maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

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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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.