Medication info
Rozetel Tablet 80/20/10 Milligrams

Rozetel Tablet 80/20/10 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [6 tablets/PTP X 5]
Approval status
Active

MFDS item code 202106686 · Approved 2021.09.29 · Insurance code 643606210

Summary

Main use
Reduction of hypertension and cardiovascular disease risk, improvement of dyslipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily, with one tablet to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g. in the morning) whenever possible. Telmisartan: - Essential hypertension: It is recommended to take 40 mg orally once daily. A dose of 20 mg once daily may also be effective for some patients. If necessary, the dose may be increased to 80 mg once daily. - Reduction of cardiovascular disease risk: It is recommended to take 80 mg orally once daily.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Reduction of hypertension and cardiovascular disease risk, improvement of dyslipidemia

  • Essential hypertension
  • cardiovascular disease
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attack
  • end-organ damage
  • high-risk diabetes
  • myocardial infarction
  • primary hypercholesterolemia
  • familial combined dyslipidemia
  • non-familial dyslipidemia
View approved original text

This medication is used for patients who need to take telmisartan and rosuvastatin/ezetimibe together. Telmisartan treats essential hypertension and reduces the risk of myocardial infarction, stroke, and death from cardiovascular disease in high-risk cardiovascular disease patients. It is particularly effective in cardiovascular disease high-risk patients over 55 years of age who cannot use ACE inhibitors. Rosuvastatin/ezetimibe lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while also increasing HDL, the good cholesterol. This medication is used as an adjunct to diet therapy to improve blood lipid levels. Therefore, this medication is used to manage both hypertension and dyslipidemia simultaneously to improve cardiovascular health.

How to take

Adult dose

This medication is taken once daily, with one tablet to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g. in the morning) whenever possible. Telmisartan: - Essential hypertension: It is recommended to take 40 mg orally once daily. A dose of 20 mg once daily may also be effective for some patients. If necessary, the dose may be increased to 80 mg once daily. - Reduction of cardiovascular disease risk: It is recommended to take 80 mg orally once daily.

Precautions

This medication can cause severe harm to the fetus or newborn if taken during pregnancy, so it must be stopped immediately if pregnancy is confirmed. Muscle-related side effects can occur, albeit rarely, and if symptoms such as muscle pain or weakness appear, a doctor should be consulted immediately. It can affect liver function, so it should not be used or should be used with caution in patients with liver disease or who have abnormal liver enzyme levels. It is contraindicated in patients with severe renal impairment or certain liver diseases. As this medication lowers blood pressure, symptoms of hypotension may occur, and patients with insufficient blood volume should be especially cautious. Interactions may occur when taken with other medications, so patients should inform their doctor or pharmacist about any medications they are taking. Caution is advised while driving or operating machinery as dizziness or drowsiness can occur. Patients with allergies to the components of this medication or specific genetic issues such as lactose intolerance should not take it. Elderly patients, diabetic patients, and those with reduced kidney function should use this medication especially carefully, and regular blood tests and physical examinations are necessary. While taking this medication, side effects such as muscle pain, fatigue, indigestion, headache, and dizziness may occur, and if symptoms are severe or persistent, medical advice should be sought.

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, peeling of skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough + fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Increased ALT
  • increased AST
  • increased Ɣ-GTP
  • increased ALP
  • abdominal pain
  • oral ulcers
  • vomiting
  • chest pain
  • palpitations
  • dizziness
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  • tinnitus
  • tympanic membrane perforation
  • hematuria
  • shingles
  • pneumonia
  • hair loss
  • painful urination
  • rhinitis
  • discomfort in the oropharynx
  • gastrointestinal disorders
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • increased urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • headache

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, and stored at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pink oval film-coated tablet

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.