Medication info

Telmisartan and Rosuvastatin Tablets 80/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
일양바이오팜(주)
Appearance
Pale orange oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Expired

MFDS item code 202101822 · Approved 2021.02.24

This product's status changed to Expired on 2026.02.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily; 20 mg once daily may be effective for some patients. It can be increased to a maximum of 80 mg once daily if necessary. For the purpose of reducing cardiovascular disease risk, the recommended oral dose is 80 mg once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: The initial dose is 5 mg once daily.

Ingredients

Manufacturer
일양바이오팜(주)

Efficacy & effects

Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)

  • Essential hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attacks
  • clinical evidence of end-organ damage
  • high-risk diabetes
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
View approved original text

This medication is used for patients who need to take telmisartan, an antihypertensive agent, and rosuvastatin, a hyperlipidemia treatment, simultaneously. Telmisartan helps treat essential hypertension and is particularly effective in reducing the risk of myocardial infarction, stroke, and death due to cardiovascular diseases in patients at high risk. Rosuvastatin is mainly used as an adjunct to diet therapy in patients with hypercholesterolemia and dyslipidemia, specifically contributing to the delay of atherosclerosis progression by lowering LDL cholesterol and reducing cardiovascular disease risk. Additionally, there are benefits in reducing the risk of stroke, myocardial infarction, and vascular revascularization procedures in high-risk patients with elevated high-sensitivity C-reactive protein levels. Therefore, this medication is used to improve cardiovascular health in patients with both hypertension and hyperlipidemia.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended oral dose is 40 mg once daily; 20 mg once daily may be effective for some patients. It can be increased to a maximum of 80 mg once daily if necessary. For the purpose of reducing cardiovascular disease risk, the recommended oral dose is 80 mg once daily. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: The initial dose is 5 mg once daily.

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. Women of childbearing potential must use appropriate contraceptive methods before taking this medication, and it should not be used during pregnancy or breastfeeding. Patients who are allergic to any ingredients in this medication or those with severely impaired liver and kidney function or certain genetic disorders should not receive this medication. Special caution is required for the elderly, patients with hyperkalemia, and those with liver impairments, and regular monitoring of liver function and muscle status should be conducted. If symptoms like muscle pain, muscle weakness, dizziness, or severe fatigue occur, consult a physician immediately and consider stopping the medication in severe cases. This medication may interact with other drugs; thus, if you are taking other medications, you must inform your doctor or pharmacist, especially regarding blood pressure medications, diuretics, and anticoagulants. Symptoms such as hypotension, dizziness, and acute renal failure may occur in case of overdose; immediate emergency treatment should be sought. Caution is advised when driving or operating machines as dizziness or drowsiness may occur. The safety and efficacy of this medication have not been established in children, and its use is not recommended. When storing, keep it out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin shedding, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination abnormalities

Mild side effects

  • Dyspepsia
  • oral dysesthesia
  • musculoskeletal stiffness
  • acne
  • itching
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
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  • pulmonary disease
  • unspecified gastrointestinal diseases
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory deficits
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • headache
  • facial spasms
  • sensory abnormalities
  • paralysis
  • cough
  • hyperventilation
  • pneumonia
  • flushing
  • erectile dysfunction
  • decreased appetite

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Doing so helps preserve the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Pale orange oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3]

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.