Medication info
Rozetelpin Tablet 40/10/10/5 Milligrams

Rozetelpin Tablet 40/10/10/5 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tabletAmlodipine Besylate›6.944mg / 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 202202189 · Approved 2022.05.23 · Insurance code 643606450

Summary

Main use
Additional control treatment for hypertension and dyslipidemia (such as hypercholesterolemia)
Who takes it
Adults
Adult dose
This medication is to be administered to adults only, taking 1 tablet once a day with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). This medication should be taken whole, without chewing, splitting, or crushing. The recommended dosage for the Telmisartan/Amlodipine combination is once daily, and it must be individualized per patient. The Rosuvastatin/Ezetimibe combination should start with 5/10 mg once daily.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Additional control treatment for hypertension and dyslipidemia (such as hypercholesterolemia)

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

This medication is used for patients who need to take both the combination of Telmisartan and Amlodipine, as well as the combination of Rosuvastatin and Ezetimibe. It is mainly prescribed for patients whose blood pressure and cholesterol levels need to be controlled at the same time, specifically for hypertension and dyslipidemia. The combination of Telmisartan and Amlodipine is effective for patients with essential hypertension who struggle to control their blood pressure with monotherapy. Additionally, the combination of Rosuvastatin and Ezetimibe helps to manage cholesterol and triglyceride levels in patients with primary hypercholesterolemia or familial and non-familial mixed dyslipidemia. This medication works to reduce total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol while increasing HDL cholesterol when used alongside dietary measures. Therefore, it is used to effectively improve hypertension and dyslipidemia.

How to take

Adult dose

This medication is to be administered to adults only, taking 1 tablet once a day with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). This medication should be taken whole, without chewing, splitting, or crushing. The recommended dosage for the Telmisartan/Amlodipine combination is once daily, and it must be individualized per patient. The Rosuvastatin/Ezetimibe combination should start with 5/10 mg once daily.

Precautions

This medication may pose a serious risk to the fetus if taken during pregnancy, especially in the second and third trimesters, so it must be discontinued immediately upon confirmation of pregnancy. If symptoms such as muscle pain or weakness appear, you must notify a healthcare professional immediately, and in some cases, discontinuation of the medication may be required. Patients with poor liver or kidney function must consult with healthcare professionals before taking this medication, and regular liver and kidney function tests are necessary. This medication should not be taken with certain liver diseases, muscle disorders, severe renal impairment, and it is necessary to inform the doctor before taking if there are any other medications. Low blood volume or sodium levels may cause hypotension for effective hypertension treatment, therefore caution is required, and should hypotensive symptoms appear, you must notify a healthcare professional immediately. This medication may increase blood potassium levels, so caution is needed with potassium supplements or potassium-containing drugs. In some patients, side effects such as angioedema, allergic reactions, liver dysfunction, gastrointestinal disturbances, and renal function decline may occur, and if these symptoms occur, you must notify a healthcare professional immediately. While taking this medication, avoid driving or operating machinery as dizziness or drowsiness may occur. Certain genetic factors, elderly patients, those with hypothyroidism, and diabetics may be at a higher risk for side effects, so it’s recommended to consult with a doctor before taking and to regularly monitor conditions during treatment. There may be interactions with other medications, so if currently taking any other medications, it’s essential to inform your healthcare provider, especially with diuretics, anticoagulants, some antibiotics, and grapefruit juice. This medication should be used alongside dietary measures, and regular blood tests and physical examinations should be conducted to check for adverse reactions during treatment.

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 fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, difficulty or shortness of breath, asthma attacks, respiratory distress with cough accompanied by fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urine

Mild side effects

  • Eyelid damage
  • head injury
  • urination difficulties
  • flushing
  • chronic gastritis
  • various gastrointestinal disturbances
  • hiatal hernia
  • dizziness
  • drowsiness
  • neurodegenerative disorders
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  • orthostatic dizziness
  • migraine
  • fatigue
  • headache
  • insomnia
  • anxiety
  • vomiting
  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal bloating
  • dry mouth
  • itching
  • rash
  • alopecia
  • dermatitis
  • skin burning sensation
  • skin disorders
  • urticaria
  • alopecia
  • sweating

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1°C to 30°C to ensure the effectiveness and safety 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.