Medication info
Rozetel Tablets 40/5/10 Milligrams

Rozetel Tablets 40/5/10 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Yellow oval film-coated tablets
Packaging
30 tablets/box [6 tablets/PTP X 5]
Approval status
Active

MFDS item code 202106690 · Approved 2021.09.29 · Insurance code 643606250

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, one tablet per day, with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. For telmisartan, a daily oral dosage of 40 mg is recommended for the treatment of essential hypertension, and 20 mg may be effective depending on the patient. If necessary, the dose may be increased to 80 mg. For the purpose of reducing the risk of cardiovascular disease, a daily oral dosage of 80 mg is recommended.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Reduction of hypertension and cardiovascular disease risk, improvement of dyslipidemia

  • 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 hyperlipidemia
  • non-familial hyperlipidemia
  • mixed dyslipidemia
  • elevated total cholesterol
View approved original text

This medication is only used for patients who must be treated with a combination of telmisartan and rosuvastatin/ezetimibe. Telmisartan is primarily used for the treatment of essential hypertension and reduces the risk of myocardial infarction, stroke, and death from cardiovascular disease in patients over the age of 55 who are at high risk for cardiovascular disease. Rosuvastatin/ezetimibe helps control cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia. Specifically, it reduces total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol, thereby supporting cardiovascular health. This medication is effectively used in the treatment of these two conditions.

How to take

Adult dose

This medication is taken once daily, one tablet per day, with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. For telmisartan, a daily oral dosage of 40 mg is recommended for the treatment of essential hypertension, and 20 mg may be effective depending on the patient. If necessary, the dose may be increased to 80 mg. For the purpose of reducing the risk of cardiovascular disease, a daily oral dosage of 80 mg is recommended.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Serious muscle issues may occur, so if muscle pain or weakness arises, consult a physician immediately. Individuals with liver dysfunction or a history of liver disease should consult healthcare professionals before taking this medication. This medication should not be used in patients with severely impaired kidney function or certain liver diseases. When combined with other medications, interactions may occur, so it is important to inform healthcare professionals about all medications taken. If a significant amount of alcohol is consumed or there is a history of liver disease, frequent liver function tests are required while taking this medication. This medication can lower blood pressure, so caution is needed if symptoms of dizziness or hypotension occur during treatment. There may be drowsiness or dizziness when driving or operating machinery, so caution is advised. There is a risk of hyperkalemia, so regular monitoring of serum potassium levels is essential. This medication may cause allergic reactions, so if symptoms such as rash, itching, or difficulty breathing occur, discontinue use immediately and notify healthcare professionals. Particularly, if liver enzyme levels are elevated in blood tests or muscle enzyme levels increase, treatment may need to be discontinued. The risk of muscle damage increases when used concurrently with fibrates, so co-administration should be avoided. Women of childbearing age should use appropriate contraceptive methods to avoid pregnancy while taking this medication. This medication contains lactose, so it should not be taken by patients with lactose intolerance. Adverse reactions reported include liver dysfunction, myalgia, gastrointestinal disturbances, headache, and dizziness; consult a healthcare professional if symptoms persist or worsen.

Side effects and when to seek care immediately

Serious side effects

Hives, Severe swelling (edema), Chest tightness, Difficulty breathing, Cold sweat, Pallor, Severe rash accompanied by high fever, Blisters, Skin peeling, Pain in the mucous membranes of the mouth/eyes, Shortness of breath or difficulty breathing, Asthma attack, Abnormal breathing 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

Mild side effects

  • Increased ALT
  • Increased AST
  • Increased Ɣ-GTP
  • Increased ALP
  • Abdominal pain
  • Oral ulceration
  • Vomiting
  • Chest pain
  • Palpitations
  • Dizziness
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  • Dyspnea
  • Dysfunction of eustachian tube
  • Tympanic membrane perforation
  • Acute kidney injury
  • Hematuria
  • Herpes zoster
  • Pneumonia
  • Hair loss
  • Dysuria
  • Rhinitis
  • Discomfort in the oropharynx
  • Pulmonary disease
  • Unspecified gastrointestinal disease
  • Benign gastrointestinal neoplasm
  • Hemorrhoids
  • Skeletal pain
  • Osteoporosis
  • Sensory loss
  • Movement disorders

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow oval film-coated tablets

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.