Medication info
Telmisartan/Amlodipine/Rosuvastatin 40/5/10 mg

Telmisartan/Amlodipine/Rosuvastatin 40/5/10 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
Pink oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500557 · Approved 2025.03.13 · Insurance code 655404800

Summary

Main use
Reduction of cardiovascular disease risk through the control of blood pressure and cholesterol (hypertension, hypercholesterolemia)
Who takes it
Adults
Adult dose
This medication is taken once daily, one tablet, with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). When administering the telmisartan/amlodipine combination, the dosage should be individualized based on the patient's response and tolerance. - 40/5 mg: Administered to patients whose blood pressure is not adequately controlled on 5 mg amlodipine or 40 mg telmisartan. - 80/5 mg

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Reduction of cardiovascular disease risk through the control of blood pressure and cholesterol (hypertension, hypercholesterolemia)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not well controlled with a combination of telmisartan and amlodipine, while rosuvastatin is primarily used as an adjunct to diet in patients with hypercholesterolemia and hyperlipidemia. Rosuvastatin is effective for various lipid disorders such as primary hypercholesterolemia, familial hypercholesterolemia, and dysbetalipoproteinemia. Additionally, it helps reduce the risk of complications after stroke, myocardial infarction, and arterial revascularization in patients at high risk for cardiovascular diseases. This medication is used to improve cardiovascular health by simultaneously managing blood pressure and blood cholesterol levels.

How to take

Adult dose

This medication is taken once daily, one tablet, with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). When administering the telmisartan/amlodipine combination, the dosage should be individualized based on the patient's response and tolerance. - 40/5 mg: Administered to patients whose blood pressure is not adequately controlled on 5 mg amlodipine or 40 mg telmisartan. - 80/5 mg

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients who are allergic to this medication's active ingredients or related substances, those with specific genetic disorders, severe liver dysfunction, or severe renal impairment should not take it. Particularly, patients with a history of angioedema or those taking certain medications may be at risk, so it is essential to consult a physician. Elderly patients or those with specific health conditions like hypertension or hyperkalemia should use it with caution, and it is important to monitor liver and kidney function periodically. If symptoms related to muscles such as myalgia, muscle weakness, or cramping occur during treatment, notify medical personnel immediately, and blood tests should be conducted if necessary to check for muscle damage. This medication may cause liver dysfunction, and liver enzyme levels should be monitored regularly; it should be discontinued if liver function deteriorates significantly. Because of possible interactions with other medications, inform healthcare providers about any current medications being taken. If breastfeeding, it is recommended to stop nursing while on this medication as it can be excreted in breast milk. Safety and efficacy have not been established in children under 18 years, so it is not recommended. In case of overdose, symptoms such as hypotension, cardiac irregularities, or renal function decline may occur, and appropriate treatment should be sought immediately at a medical facility. It is advised to keep this medication out of reach of children and not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, angioedema, hypotension due to decreased blood volume, angioedema (including fatal outcomes), thrombocytopenia, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities associated with cough and fever, jaundice (yellowing of the skin or eyes)

Mild side effects

  • Headache
  • dizziness
  • lumbar pain
  • sinusitis
  • diarrhea
  • sore throat
  • flu-like symptoms
  • dyspepsia
  • myalgia
  • urinary tract infection
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  • abdominal pain
  • dizziness
  • pain
  • fatigue
  • cough
  • hypertension
  • chest pain
  • nausea
  • fever
  • leg pain
  • malaise
  • palpitations
  • rapid pulse
  • leg edema
  • insomnia
  • drowsiness
  • sensory disturbances
  • involuntary muscle contractions
  • sensory loss
  • flatulence
  • constipation
  • gastritis
  • vomiting
  • dry mouth
  • hemorrhoids
  • gastroenteritis
  • enteritis
  • gastroesophageal reflux

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 container that blocks light. It is also important to store it at a cool room temperature, specifically between 1 and 30 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

Pink oval film-coated 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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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.