Medication info
Rosetelpin Tablets 40/20/10/5 mg

Rosetelpin Tablets 40/20/10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›20.8mg / 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 202202190 · Approved 2022.05.23 · Insurance code 643606440

Summary

Main use
Additional treatment for hypertension and dyslipidemia (cholesterol, etc.) control
Who takes it
Adults
Adult dose
This medication is administered only to adults, and dosages should be individualized for each patient. The recommended dose is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). Do not chew or split the tablet; swallow it whole. The recommended dose for the telmisartan/amlodipine combination is once daily. - 40/5 mg: Amlodipine 5 mg

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

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

  • 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 treat both hypertension and dyslipidemia simultaneously. It provides assistance to patients with essential hypertension who do not achieve sufficient blood pressure control with monotherapy using telmisartan and amlodipine. Additionally, the combination of rosuvastatin and ezetimibe is effective in improving blood cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Taking this medication helps lower bad fat levels like LDL cholesterol while raising good fat levels like HDL cholesterol, thereby reducing the risk of cardiovascular disease. Therefore, this medication is used to comprehensively control blood pressure and blood lipid levels.

How to take

Adult dose

This medication is administered only to adults, and dosages should be individualized for each patient. The recommended dose is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). Do not chew or split the tablet; swallow it whole. The recommended dose for the telmisartan/amlodipine combination is once daily. - 40/5 mg: Amlodipine 5 mg

Precautions

This medication can pose serious risks to the fetus if used during pregnancy; therefore, it should not be used by women who are pregnant or may become pregnant. If symptoms of muscle pain or weakness occur, you must notify your doctor immediately, as there is a risk of severe muscle damage (rhabdomyolysis). Liver function abnormalities may occur, so liver function tests should be conducted regularly during treatment. Patients with liver disease must consult their doctor before taking this medication. Patients with reduced kidney function should be aware of the potential risk of worsening kidney function while taking this medication; renal status should be monitored regularly through blood tests. As blood pressure may drop too low, report any signs of hypotension to healthcare professionals immediately, and patients who are deficient in fluids or sodium should correct those conditions before taking this medication. There may be interactions with other medications, so any current medications should be reported to your doctor or pharmacist, particularly precautions are necessary when used in conjunction with potassium supplements or diuretics. It is advisable to avoid alcohol consumption while taking this medication, and caution should be exercised when driving or operating machinery due to the possibility of dizziness or drowsiness. Individuals with a history of hypersensitivity or allergy should not use this medication; if symptoms such as skin rash, itching, or difficulty breathing occur after taking the medication, discontinue it immediately and consult a healthcare professional. Elderly patients, individuals with liver disease or kidney disease should use this medication with caution, as dose adjustments and regular monitoring may be necessary. Since this medication contains multiple components, it should be taken strictly in accordance with a doctor's prescription and instructions. Altering or discontinuing the dosage without medical advice is prohibited.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, angioedema (potentially fatal), toxic epidermal necrolysis, liver function abnormalities/liver failure, jaundice, kidney dysfunction including acute renal failure, kidney impairment, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, severe muscle weakness or ophthalmoplegia, heart

Mild side effects

Eyelid damage, head injury, difficulty urinating, flushing, chronic gastritis, various gastrointestinal disorders, hiatal hernia, upper respiratory tract infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), headache, dizziness, cough, hyperventilation, pneumonia, itching, rash, hair loss, dermatitis, skin burning sensation, skin disorders, hives, weakness, fatigue, lethargy, pain, weight gain/loss, anxiety, sensory loss/paresthesia,

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is best stored at room temperature between 1°C and 30°C.

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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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.