Medication info

New Statin TS Tablet 40/5/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
A round bilayer tablet composed of a white layer and a light blue layer
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202302813 · Approved 2023.09.25

Summary

Main use
Effectively improves hypertension and hypercholesterolemia and reduces the risk of cardiovascular diseases
Who takes it
Adults
Adult dose
This medication is to be taken once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The dosages of telmisartan/amlodipine combination and rosuvastatin should be individualized for each patient. The doses for the telmisartan/amlodipine combination are as follows: - 40/5 mg: For patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or 40 mg of telmisartan.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Effectively improves hypertension and hypercholesterolemia and reduces the risk of cardiovascular diseases

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated 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 prescribed to patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy using a combination of telmisartan and amlodipine. Additionally, rosuvastatin calcium serves as an adjunct to the diet in patients with hypercholesterolemia and dyslipidemia, lowering blood cholesterol and LDL levels, and delaying the progression of atherosclerosis. For patients at high risk for cardiovascular diseases, it helps reduce the risk of stroke, myocardial infarction, and vascular reconstruction. Therefore, this medication is effective for the treatment of patients with both hypertension and dyslipidemia and is used to improve cardiovascular health.

How to take

Adult dose

This medication is to be taken once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The dosages of telmisartan/amlodipine combination and rosuvastatin should be individualized for each patient. The doses for the telmisartan/amlodipine combination are as follows: - 40/5 mg: For patients whose blood pressure is not adequately controlled with 5 mg of amlodipine or 40 mg of telmisartan.

Precautions

This medication can cause serious harm to the fetus and newborn when taken during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Do not take if you are allergic to any of the ingredients in this medication or similar medications. It should not be administered to patients with severe impairment of liver or kidney function, certain heart diseases, or a history of angioedema. Elderly patients, those with hypotension, patients with mild liver impairment, and those with high potassium levels should take caution and may require regular monitoring. If symptoms such as muscle pain or weakness occur, consult a physician immediately, and in severe cases, discontinuation of the medication may be necessary. This medication can affect liver and kidney function, so regular blood tests and liver function tests are important. Since it may interact with other medications, inform your physician or pharmacist of any other medications you are taking. Women of childbearing potential should use appropriate contraception, and if breastfeeding, should either avoid taking this medication or discontinue breastfeeding. The safety of this medication has not been sufficiently confirmed for children; therefore, it is not recommended for patients under 18 years of age. In case of overdose, symptoms may include low blood pressure, dizziness, and renal impairment, and immediate medical attention should be sought. Store this medication out of reach of children and be cautious as transferring it to another container may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough+fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Dyspepsia
  • frequent bowel movement
  • diabetes
  • dizziness
  • dry rales
  • urticaria
  • peripheral edema
  • back pain
  • pharyngitis
  • diarrhea
Show 23 more
  • headache
  • leukopenia
  • myalgia
  • dysuria
  • rhinitis
  • pharyngeal discomfort
  • pulmonary diseases
  • unspecified gastrointestinal disorders
  • benign gastric neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory disturbance
  • movement disorders
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • fever
  • leg pain
  • fatigue
  • palpitations
  • drug-dependent edema

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

Storage

This medication is packed in a special package that protects it from light and air. Store the medication at room temperature between 1°C and 30°C. This will help maintain its effectiveness over time.

Appearance and packaging

Appearance

A round bilayer tablet composed of a white layer and a light blue layer

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle

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.