Medication info
Rozetelpin Tablets 80/10/10/5 Milligrams

Rozetelpin Tablets 80/10/10/5 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tabletAmlodipine Besylate›6.944mg / 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 202202192 · Approved 2022.05.23 · Insurance code 643606420

Summary

Main use
Additional control treatment for hypertension and dyslipidemia (cholesterol, etc.)
Who takes it
Adults
Adult dose
This medication is to be administered only to adults, and the dosage must be individualized for each patient. The recommended dosage is one tablet once a day, taken with water, regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). Do not chew, split, or crush this medication; take it whole. The recommended dosage for the telmisartan/amlodipine combination is once daily. For patients with liver impairment, the daily dosage of telmisartan should not exceed 40 milligrams.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Additional control treatment for hypertension and dyslipidemia (cholesterol, etc.)

  • Essential hypertension
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
View approved original text

This medication is used for patients who are treated simultaneously with a combination of telmisartan/amlodipine and rosuvastatin/ezetimibe. It is primarily prescribed when additional treatment is needed to control hypertension and dyslipidemia. Telmisartan and amlodipine are used for the treatment of essential hypertension and assist when blood pressure cannot be adequately controlled with monotherapy. Rosuvastatin and ezetimibe play a role in improving cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. This medication, in conjunction with a diet, reduces total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol, thereby improving vascular health. Therefore, it is used for the effective treatment of hypertension and dyslipidemia.

How to take

Adult dose

This medication is to be administered only to adults, and the dosage must be individualized for each patient. The recommended dosage is one tablet once a day, taken with water, regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). Do not chew, split, or crush this medication; take it whole. The recommended dosage for the telmisartan/amlodipine combination is once daily. For patients with liver impairment, the daily dosage of telmisartan should not exceed 40 milligrams.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, particularly in the second and third trimesters. Therefore, if pregnancy is confirmed, the medication should be stopped immediately. If muscle problems or symptoms such as muscle pain, cramps, or weakness occur, inform a doctor immediately and get tested. Patients with poor liver function or liver disease should consult healthcare professionals before taking this medication and should undergo regular liver function tests. Patients with severely reduced kidney function or specific kidney diseases should not take this medication. Do not administer this medication to individuals who are allergic to any of its components or have had hypersensitivity reactions to similar medications in the past. Drug interactions may occur if taken with certain other medications; therefore, inform healthcare professionals about all currently taken medications. Since this medication lowers blood pressure, symptoms of hypotension (dizziness, fainting, etc.) may appear, and if symptoms occur, inform healthcare professionals immediately. During the use of this medication, regular blood tests and liver function tests should be conducted, and if any abnormal symptoms arise, consultations should be sought immediately. Caution is advised when driving or operating dangerous machinery, as dizziness or drowsiness may occur. This medication contains specific colorants, so patients allergic to these components should consult healthcare professionals before use. Patients with serious heart or vascular issues, especially those with severe hypotension, congestive heart failure, or unstable conditions following acute myocardial infarction, should be cautious with the usage of this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin reactions, asthma attacks, respiratory abnormalities accompanied by cough and fever, difficulty breathing or shortness of breath, jaundice (yellowing of the skin or eyes), extreme malaise, liver abnormalities (jaundice), sudden and severe reactions

Mild side effects

  • Eyelid damage
  • head injury
  • urination difficulties
  • flushing
  • chronic gastritis
  • various gastrointestinal disorders
  • hiatus hernia
  • dizziness
  • drowsiness
  • neurodegenerative disorders
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  • postural dizziness
  • migraine
  • fatigue
  • musculoskeletal stiffness
  • musculoskeletal discomfort
  • muscle weakness
  • dermatitis
  • skin burning
  • skin disorders
  • alopecia
  • oropharyngeal pain
  • nasal congestion
  • pelvic pain
  • breast cysts
  • drooping eyelids
  • diabetic retinopathy
  • ear discomfort
  • benign esophageal neoplasm

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

Storage

Store this medication in a sealed container to protect it from air and moisture. Additionally, it is advisable to store the medication at room temperature between 1°C and 30°C. Avoid excessively hot or cold conditions to maintain 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.