Medication info
Telmisartan, Rosuvastatin Calcium, Ezetimibe, Amlodipine Besylate Tablets 80/5/10/5 mg

Telmisartan, Rosuvastatin Calcium, Ezetimibe, Amlodipine Besylate Tablets 80/5/10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Orange oval-shaped film-coated tablets
Packaging
30 tablets/box [6 tablets/PTP X 5]
Approval status
Active

MFDS item code 202203053 · Approved 2022.07.21 · Insurance code 645406190

Summary

Main use
Additional treatment for hypertension and dyslipidemia (hypercholesterolemia, etc.) management
Who takes it
Adults
Adult dose
This medication is administered only to adults, with a standard dose of 1 tablet once daily, regardless of meals, taken with water. It is recommended to take it at the same time every day if possible. The tablet should not be chewed, split, or crushed; it should be taken whole. The telmisartan/amlodipine combination is administered once daily, and the dosage should be individualized according to the patient's condition. Patients with liver impairment should not exceed a daily dose of 40 mg of telmisartan and, for those aged 75 and older...

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Additional treatment for hypertension and dyslipidemia (hypercholesterolemia, etc.) management

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is used for hypertensive patients who are taking a combination of telmisartan and amlodipine but have insufficient blood pressure control, as well as for patients who have hypercholesterolemia or dyslipidemia while taking a combination of rosuvastatin and ezetimibe. Specifically, it is effective in patients with essential hypertension who have difficulty controlling blood pressure with monotherapy, and it helps improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia or mixed dyslipidemia while increasing good cholesterol (HDL). This combined therapy is used to simultaneously manage blood pressure and lipid levels, thereby improving the overall cardiovascular health of patients.

How to take

Adult dose

This medication is administered only to adults, with a standard dose of 1 tablet once daily, regardless of meals, taken with water. It is recommended to take it at the same time every day if possible. The tablet should not be chewed, split, or crushed; it should be taken whole. The telmisartan/amlodipine combination is administered once daily, and the dosage should be individualized according to the patient's condition. Patients with liver impairment should not exceed a daily dose of 40 mg of telmisartan and, for those aged 75 and older...

Precautions

This medication can cause serious harm to the fetus, especially during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Muscle-related side effects may occur rarely; if muscle pain or weakness occurs, notify your doctor immediately. Patients with allergies to any of the ingredients in this medication or those with severely impaired liver and kidney function should not take it. Patients with mild liver impairment may require dosage adjustment, and caution should be exercised in those with a history of liver disease. As this medication lowers blood pressure, symptoms of hypotension may appear; consult your doctor if symptoms are severe. Hyperkalemia may occur, so it is important to regularly check serum potassium levels. This medication may interact with various other drugs; it is essential to inform the physician or pharmacist of any current medications being taken. Dizziness or drowsiness may occur while driving or operating machinery; caution is advised. In rare cases, serious skin reactions, liver function abnormalities, or worsening kidney function have been reported; consult healthcare professionals immediately if any abnormal symptoms arise. It is safe to monitor for any abnormal signs by regularly conducting blood tests and liver function tests while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rashes accompanied by high fever, blisters, skin peeling, oral/ocular mucosa pain, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Eyelid damage
  • head injuries
  • urinary difficulties
  • flushing
  • chronic gastritis
  • various gastrointestinal disorders
  • hiatal hernia
  • facial edema
  • unusual sensations
  • drug intolerance
Show 19 more
  • irritable bowel syndrome
  • esophagitis
  • dizziness
  • drowsiness
  • neurodegenerative disorders
  • positional dizziness
  • migraines
  • glucose tolerance disorders
  • depression
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis
  • soft tissue infections
  • hepatic steatosis
  • liver dysfunction
  • hepatic toxicity
  • acute hepatitis
  • toxicity

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

Storage

Keep this medication stored in a tightly sealed container to prevent air or moisture from entering. It is best to store it at room temperature, specifically between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Orange oval-shaped film-coated tablets

Package unit

30 tablets/box [6 tablets/PTP X 5]

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.