Medication info

Telmisartan and Rosuvastatin Tablets 40/10 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Light orange oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Expired

MFDS item code 202101731 · Approved 2021.02.22

This product's status changed to Expired on 2026.02.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypertension and dyslipidemia improvement and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
Telmisartan: For the treatment of essential hypertension, an oral dose of 40 mg once daily is recommended, which may be effective at 20 mg once daily depending on the patient. If necessary, the dose may be increased to 80 mg once daily. For the purpose of reducing the risk of cardiovascular disease, an oral dose of 80 mg once daily is recommended. Patients with hepatic impairment (mild to moderate) should not exceed 40 mg once daily. Rosuvastatin Calcium: Primarily for

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Treatment for hypertension and dyslipidemia improvement and reduction of cardiovascular disease risk

  • Essential hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attacks
  • clinical evidence of end-organ damage
  • high-risk diabetes
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
View approved original text

This medication is suitable for patients who require the combined use of telmisartan and rosuvastatin. Telmisartan treats hypertension and reduces the risk of myocardial infarction, stroke, and mortality due to cardiovascular diseases in patients at high risk. Rosuvastatin aids in treating hypercholesterolemia and dyslipidemia, slowing the progression of atherosclerosis and effectively reducing the risk of stroke and myocardial infarction in certain high-risk groups. The two medications can be used together to improve both blood pressure control and cholesterol management, thereby overall reducing the risk of cardiovascular diseases.

How to take

Adult dose

Telmisartan: For the treatment of essential hypertension, an oral dose of 40 mg once daily is recommended, which may be effective at 20 mg once daily depending on the patient. If necessary, the dose may be increased to 80 mg once daily. For the purpose of reducing the risk of cardiovascular disease, an oral dose of 80 mg once daily is recommended. Patients with hepatic impairment (mild to moderate) should not exceed 40 mg once daily. Rosuvastatin Calcium: Primarily for

Precautions

This medication should not be taken during pregnancy. Taking this medication during pregnancy can cause serious harm to the fetus, and in severe cases, may lead to fetal death. If pregnancy is confirmed, discontinue use immediately. This medication should not be administered to individuals allergic to its components, pregnant women or those who may become pregnant, or breastfeeding women. Particularly, women of childbearing potential should only take this medication if they are aware of the potential risks to the fetus. It is safe to avoid use in patients with severe liver impairment, problems with bile excretion, active liver disease, muscle disorders, history of vascular swelling, severe renal dysfunction, or when combined with specific immunosuppressants. Elderly patients, those with high serum potassium levels, mild liver dysfunction, cardiovascular or vascular disorders, gastrointestinal disorders, or renal vascular disorders should use this medication cautiously, and regular blood tests and liver function tests should be conducted during treatment. This medication may cause muscle-related adverse effects such as myalgia, muscle weakness, or cramps; consult a physician immediately if these symptoms occur, particularly to assess muscle damage through creatine kinase (CK) testing. Adverse effects such as liver function abnormalities, hypotension, dizziness, dyspepsia, and pruritus may occur, so report any unusual symptoms to healthcare professionals. When taking this medication with others, be mindful of interactions, particularly when combined with antihypertensives, certain lipid-lowering agents, diuretics, and potassium supplements; blood pressure, renal function, and electrolyte levels should be monitored frequently. Pregnant or breastfeeding women should not take this medication, and women planning to become pregnant should use appropriate contraception. Safety and efficacy in pediatric populations have not been established, so avoiding administration in children is advisable. In cases of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur; seek appropriate treatment immediately at a medical facility. Lastly, keep this medication out of the reach of children, and avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthmatic attack, respiratory distress accompanied by cough and fever, skin or eye yellowing (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, vision disturbances, paralysis, urination

Mild side effects

  • Dyspepsia
  • oral paresthesia
  • muscular stiffness
  • acne
  • pruritus
  • dizziness
  • nasopharyngitis
  • dysuria
  • rhinitis
  • oral discomfort
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  • pulmonary diseases
  • unspecified gastrointestinal diseases
  • benign gastrointestinal neoplasms
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • abdominal pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the medication's efficacy.

Appearance and packaging

Appearance

Light orange oval film-coated tablet

Package unit

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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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.