Medication info

Rometel Tablet 40/20 mg (Telmisartan, Rosuvastatin Calcium)

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›40mg / 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 202005527 · 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
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)
Who takes it
Adults
Adult dose
Telmisartan: Take 20–80 mg orally once daily. For essential hypertension, 40 mg is recommended. For the purpose of reducing the risk of cardiovascular disease, 80 mg once daily is recommended. Patients with liver dysfunction should not exceed 40 mg once daily. Rosuvastatin Calcium: Initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily, with a possible maximum increase to 20 mg once daily. It can be taken regardless of meals.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

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

  • Essential hypertension
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medication is used for patients requiring both Telmisartan and Rosuvastatin. Telmisartan helps reduce the risk of myocardial infarction, stroke, and cardiovascular death in patients with essential hypertension, especially those at high risk of cardiovascular disease. On the other hand, Rosuvastatin is used to improve dyslipidemia such as hypercholesterolemia, slow the progression of atherosclerosis, and also effectively reduce the risk of cardiovascular disease. The combination of these two drugs helps to control blood pressure and blood lipids simultaneously, effectively managing cardiovascular health.

How to take

Adult dose

Telmisartan: Take 20–80 mg orally once daily. For essential hypertension, 40 mg is recommended. For the purpose of reducing the risk of cardiovascular disease, 80 mg once daily is recommended. Patients with liver dysfunction should not exceed 40 mg once daily. Rosuvastatin Calcium: Initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily, with a possible maximum increase to 20 mg once daily. It can be taken regardless of meals.

Precautions

This medication can cause severe harm or death to a fetus or newborn if used during pregnancy; therefore, it must be discontinued immediately if pregnancy is confirmed. People allergic to this medication or its components, pregnant or potentially pregnant women, nursing mothers, and women of childbearing age who are not using adequate contraception should not use this medication. Patients with severe liver or kidney impairment, certain liver diseases, muscle diseases, and those taking certain other medications should avoid or use this medication with caution. Particular caution is advised for the elderly, patients with hyperkalemia, liver dysfunction, and cardiovascular disease; regular liver function tests and muscle-related evaluations should be conducted. This medication can cause serious muscle-related adverse effects such as myalgia, myopathy, and, rarely, rhabdomyolysis; if symptoms such as muscle pain or weakness occur, immediate consultation with a healthcare provider is necessary. Additionally, it may lead to excessively low blood pressure, and if symptoms of hypotension occur, appropriate measures should be taken. It is important to regularly monitor serum potassium levels and kidney function. This medication can interact with other drugs; therefore, be sure to inform your healthcare provider about all medications currently being taken, especially if using specific diuretics, potassium supplements, anticoagulants, or immunosuppressants. It is safe not to use this medication during pregnancy or while nursing, and women planning to become pregnant should use appropriate contraception. Safety and efficacy in children have not been established, so it is not recommended for pediatric use. In cases of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, necessitating immediate medical treatment, as there is no specific antidote and appropriate symptomatic treatment is required. While taking this medication, caution should be exercised as drowsiness or dizziness may occur while driving or operating machinery. Finally, this medication should be kept out of reach of children, and transferring it to other containers should be avoided as it may lead to deterioration of quality and cause accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory symptoms accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, paralysis, urine retention

Mild side effects

Headache, orthostatic dizziness, sleep paralysis, increased blood pressure, hypotension, elevated ALT, dysuria, rhinitis, discomfort in the oral cavity and pharynx, respiratory diseases, unspecified gastrointestinal diseases, benign gastrointestinal tumors, hemorrhoids, skeletal pain, osteoporosis, sensory disturbance, movement disorder, atherosclerosis, frequent urination, tinnitus, hearing loss, bad breath, fatty liver, depression, insomnia, anxiety, fainting, visual disturbance, dizziness, bradycardia, tachycardia, hypotension, orthostatic hypotension, abdominal pain

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

Storage

This medication is sensitive to air and moisture; therefore, it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1°C and 30°C room temperature to preserve the effectiveness and safety of the medication.

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.

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.