Medication info

Romitel Tablets 80/20 mg (Telmisartan, Rosuvastatin Calcium)

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Expired

MFDS item code 202005524 · Approved 2020.07.29

This product's status changed to Expired on 2025.10.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypertension and hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
Telmisartan: The recommended oral dose is 40 mg once daily; however, 20 mg once daily may be effective for some patients. If necessary, the dose may be increased up to 80 mg once daily. For the purpose of reducing cardiovascular disease risk, the recommended oral dose is 80 mg once daily. Patients with liver impairment (mild to moderate): should not exceed 40 mg once daily. Rosuvastatin Calcium: The recommended oral dose is 5 mg once daily.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Improvement of hypertension and hypercholesterolemia and reduction of cardiovascular disease risk

  • Essential hypertension
  • hypercholesterolemia
  • dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medication is used for patients who require simultaneous treatment with Telmisartan and Rosuvastatin. Telmisartan is primarily used for the treatment of essential hypertension and helps reduce the risk of myocardial infarction, stroke, and mortality due to cardiovascular diseases in high-risk patients. Rosuvastatin is used as an adjunct to dietary therapy for hypercholesterolemia, particularly in familial hypercholesterolemia and mixed dyslipidemia, lowering LDL cholesterol and total cholesterol levels to delay the progression of atherosclerosis. Additionally, it contributes to reducing the risks of stroke, myocardial infarction, and peripheral vascular revascularization in middle-aged patients with elevated high-sensitivity C-reactive protein levels at high risk of cardiovascular disease. Thus, this medication effectively improves cardiovascular health through blood pressure and lipid management.

How to take

Adult dose

Telmisartan: The recommended oral dose is 40 mg once daily; however, 20 mg once daily may be effective for some patients. If necessary, the dose may be increased up to 80 mg once daily. For the purpose of reducing cardiovascular disease risk, the recommended oral dose is 80 mg once daily. Patients with liver impairment (mild to moderate): should not exceed 40 mg once daily. Rosuvastatin Calcium: The recommended oral dose is 5 mg once daily.

Precautions

This medication can cause serious harm to fetuses and newborns if given to pregnant women, so it should be discontinued immediately upon confirmation of pregnancy. Women with allergies to any components of this medication, those who are pregnant or nursing, or women of childbearing potential not using adequate contraception should not take this medication. Patients with severe liver impairment, bile obstruction, muscle diseases, severe renal impairment, or those taking certain concomitant medications should not use this medication. Elderly patients, those with high potassium levels, and patients with mild liver dysfunction should use this medication with caution and undergo regular liver function tests and muscle-related tests. This medication may cause symptoms such as myalgia, muscle weakness, or muscle cramps, so if such symptoms occur, consult a doctor immediately. During the use of this medication, liver function and muscle condition should be regularly monitored for abnormalities, and especially if muscle enzyme levels significantly increase above normal, medication should be discontinued. Interactions may occur when taken with other antihypertensives or lipid-lowering medications, so it is vital to inform your doctor about any other medications being taken. This medication can lower blood pressure, which may result in symptoms of hypotension, particularly in patients who are dehydrated or have low blood volume. It is recommended not to take this medication within 24 hours prior to surgery; patients at risk of acute renal deterioration should use this medication with caution. Women who may become pregnant should use adequate contraception while taking this medication and discontinue it immediately upon confirmation of pregnancy. This medication is not recommended for children as its safety and efficacy have not been established. In case of overdose, symptoms such as hypotension, dizziness, and arrhythmias may occur, and immediate medical attention is necessary. During the use of this medication, caution is advised in driving or operating machinery due to possible dizziness or drowsiness.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, exfoliative skin, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, decreased urination

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • elevated blood pressure
  • decreased blood pressure
  • hypotension
  • elevated ALT
  • painful urination
  • rhinitis
  • discomfort in the oral pharynx
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  • pulmonary diseases
  • gastrointestinal disorders
  • hemorrhoids
  • musculoskeletal pain
  • osteoporosis
  • sensory disturbances
  • movement disorders
  • atherosclerosis
  • increased urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • fainting
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • abdominal pain
  • diarrhea
  • gastrointestinal disturbances

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is essential to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP*3]

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.

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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.