Medication info
Rostel Plus Tablets 40/5/10 milligrams

Rostel Plus Tablets 40/5/10 milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Oval, bicolored tablets consisting of a white layer and a light blue layer
Packaging
For domestic use - 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202302007 · Approved 2023.06.29 · Insurance code 651206080

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)
Who takes it
Adults
Adult dose
This medication should be taken once daily as one tablet irrespective of meals, and it is recommended to take it at the same time every day (e.g., in the morning). The dosage of the telmisartan/amlodipine combination should be individualized based on the patient, with the following administration based on blood pressure control: - 40/5 milligrams: for patients whose blood pressure is not properly controlled with amlodipine 5 milligrams or telmisartan 40 milligrams. - 80

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure even with the administration of telmisartan and amlodipine. Additionally, rosuvastatin is used as an adjunctive treatment for patients with hypercholesterolemia and dyslipidemia when dietary control and exercise are insufficient. This medication helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delays the progression of atherosclerosis, and reduces the risk of cardiovascular diseases. Particularly, it is effective in reducing the risk of stroke, myocardial infarction, and vascular revascularization in middle-aged or older patients with cardiovascular disease risk factors. This medication is effectively used for the treatment of hypertension and dyslipidemia.

How to take

Adult dose

This medication should be taken once daily as one tablet irrespective of meals, and it is recommended to take it at the same time every day (e.g., in the morning). The dosage of the telmisartan/amlodipine combination should be individualized based on the patient, with the following administration based on blood pressure control: - 40/5 milligrams: for patients whose blood pressure is not properly controlled with amlodipine 5 milligrams or telmisartan 40 milligrams. - 80

Precautions

This medication can cause severe harm to the fetus and newborn and should be discontinued immediately upon confirmation of pregnancy. Avoid taking if allergic to any ingredients in this medication or similar drugs. Administration should be avoided in patients with severe liver or kidney dysfunction, certain heart diseases, and those with a history of angioedema. Special caution is required for elderly patients, patients with impaired liver function, and patients with excessively low blood pressure. If symptoms such as muscle pain, muscle weakness, or muscle cramps occur, consult a physician promptly, and discontinue use if severe. The risk of side effects may increase when taking this medication with other specific drugs, so patients should inform their doctor or pharmacist if they are taking any other medications. Women of childbearing potential should use appropriate contraceptive methods while taking this medication, and it is advised not to take it while breastfeeding. The safety and efficacy of this medication have not been sufficiently established for children and adolescents under 18, and it is not recommended in these populations. In case of overdose, symptoms such as hypotension, dizziness, and arrhythmias may occur, so medical assistance should be sought immediately. This medication should be stored in a cool, dry place away from direct sunlight and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blistering, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormality (jaundice)

Mild side effects

  • Dyspepsia
  • frequent bowel movements
  • diabetes
  • dizziness
  • dry pruritic rash
  • urticaria
  • peripheral edema
  • dyspepsia
  • dizziness
  • headache
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  • unstable angina
  • onychomycosis
  • lumbar spinal stenosis
  • ear discharge
  • vertigo
  • chronic gastritis
  • hiatal hernia
  • various gastrointestinal disturbances
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary disease
  • unspecified gastroenteritis
  • benign gastric tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis

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

Storage

This medication is sensitive to light and should be stored in a light-protective, tightly closed container. It is recommended to maintain a storage temperature between 1°C and 30°C. Proper storage can help maintain the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

Oval, bicolored tablets consisting of a white layer and a light blue layer

Package unit

For domestic use - 30 tablets/box [10 tablets/PTP x 3]

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.