Medication info
Rosetel Tablets 80/5/10 mg

Rosetel Tablets 80/5/10 mg

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

MFDS item code 202106688 · Approved 2021.09.29 · Insurance code 643606230

Summary

Main use
Reduces hypertension and cardiovascular disease risk, improves dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered only to adults, with a recommended dosage of 1 tablet once daily taken with water, regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Telmisartan 1. Primary Hypertension: It is recommended to administer 40 mg orally once a day, and according to patient response, 20 mg may be effective. If necessary, the dosage can be increased up to 80 mg. 2. Reducing the risk of cardiovascular disease: Administer 80 mg orally once daily.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Reduces hypertension and cardiovascular disease risk, improves dyslipidemia

  • Primary hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attack
  • clinical evidence of damage to peripheral organs
  • high-risk diabetes
  • primary hypercholesterolemia
  • heterozygous familial dyslipidemia
  • non-familial dyslipidemia
  • mixed dyslipidemia
  • elevated total cholesterol
View approved original text

This medication is used for patients who need to take Telmisartan and Rosuvastatin/Ezetimibe simultaneously. Telmisartan helps lower the risk of myocardial infarction, stroke, and death due to cardiovascular disease in high-risk patients, alongside the treatment of primary hypertension. It is especially recommended for patients over 55 years of age at risk of cardiovascular diseases who cannot use ACE inhibitors. Rosuvastatin/Ezetimibe is used as an adjunct to diet to improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol levels. Therefore, this medication is used to enhance cardiovascular health by managing both blood pressure and cholesterol simultaneously.

How to take

Adult dose

This medication is administered only to adults, with a recommended dosage of 1 tablet once daily taken with water, regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Telmisartan 1. Primary Hypertension: It is recommended to administer 40 mg orally once a day, and according to patient response, 20 mg may be effective. If necessary, the dosage can be increased up to 80 mg. 2. Reducing the risk of cardiovascular disease: Administer 80 mg orally once daily.

Precautions

This medication can cause serious harm to the fetus or newborn when taken during pregnancy, so it must be stopped immediately if pregnancy is confirmed. Muscle-related side effects, such as myalgia or rhabdomyolysis, may occur rarely, so if severe muscle pain or weakness is felt, consultation with a doctor should be sought immediately. Due to potential effects on liver function, this medication should not be taken by patients with liver disease or elevated liver enzyme levels, and liver function tests should be done regularly while taking this medication. Patients with impaired kidney function or certain cardiovascular diseases should consult a doctor before taking this medication and, if necessary, periodically check kidney function and blood pressure. Patients with allergies to any component of this medication or those with specific genetic metabolic disorders should not take it. There may be interactions with other medications, so if you are currently taking other medications, be sure to inform your healthcare provider. It is advisable to avoid or limit alcohol consumption while taking this medication, and caution should be exercised as dizziness or drowsiness may occur during driving or operating machinery. If symptoms such as muscle pain, rash, breathing difficulties, swelling of the face or lips occur, cease taking the medication immediately and consult your healthcare provider. This medication should be used in conjunction with a proper diet, and continuous lifestyle improvements are particularly necessary for controlling cholesterol levels. Elderly or diabetic patients may be at higher risk for adverse reactions and should be observed more carefully.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanying respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urinary changes

Mild side effects

  • Increased ALT
  • increased AST
  • increased Ɣ-GTP
  • increased ALP
  • abdominal pain
  • oral ulcers
  • vomiting
  • chest pain
  • palpitations
  • dizziness
Show 20 more
  • ear and labyrinth dysfunction
  • tympanic membrane perforation
  • hematuria
  • shingles
  • pneumonia
  • hair loss
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
  • lung disease
  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is best to maintain storage temperatures between 1°C and 30°C. This will help preserve the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Orange 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.