Medication info

Telosetin Tablet 40/20 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202001837 · Approved 2020.03.17

This product's status changed to Approval withdrawn on 2024.12.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Treatment of hypertension and hyperlipidemia (reducing cardiovascular disease risk)

  • Essential hypertension
  • coronary artery disease
  • peripheral artery disease
  • stroke
  • transient ischemic attack
  • damage to peripheral organs
  • high-risk diabetes
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
View approved original text

This medication is used for patients who need to take telmisartan and rosuvastatin simultaneously. Telmisartan helps treat essential hypertension and reduce the risk of cardiovascular diseases, especially in high-risk patients with a high risk of myocardial infarction, stroke, or death due to cardiovascular diseases. Rosuvastatin is used as an adjunct therapy for individuals whose hypercholesterolemia and dyslipidemia are difficult to control with diet and exercise. It also slows the progression of atherosclerosis and reduces the risk of certain cardiovascular diseases, thereby lowering the risk of myocardial infarction or stroke. Therefore, this medication effectively manages hypertension and hyperlipidemia simultaneously to improve the risk of cardiovascular diseases.

How to take

Adult dose

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

Precautions

This medication can cause serious harm to the fetus and newborn, especially during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Individuals allergic to this drug or its components, pregnant or potentially pregnant women, and nursing mothers should not take this medication. Patients with severe liver damage or problems with bile secretion should not take this medication, and caution is required in patients with liver function abnormalities. Patients with muscle diseases or hereditary angioedema, those with severe kidney dysfunction, and those taking certain immunosuppressants are prohibited from using this medication. Elderly patients, those with high serum potassium levels, or patients with mild liver impairment should use this medication cautiously and undergo regular liver enzyme tests. This medication may cause skeletal-related side effects such as myalgia, muscle weakness, and rhabdomyolysis; therefore, immediate consultation with a physician is required if unusual symptoms occur. There is a risk of dangerously low blood pressure; hence, patients with cardiovascular or cerebrovascular diseases should be cautious when taking it. During the use of this medication, liver and kidney function, serum potassium levels, and muscle-related indicators should be regularly monitored, and treatment should be discontinued immediately if abnormalities are detected. When used in combination with certain medications, the risk of side effects can increase due to interactions; therefore, consult healthcare professionals if there are other medications being taken. This medication may cause drowsiness or dizziness; thus, caution is needed when driving or operating machinery. Store out of reach of children and do not transfer to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice, liver abnormalities, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, serious neurological symptoms, changes in urine output

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • increased blood pressure
  • decreased diastolic blood pressure
  • hypotension
  • elevated ALT
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
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  • pulmonary disease
  • nonspecific gastrointestinal diseases
  • benign gastrointestinal tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • pollakiuria
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature to retain its efficacy for as long as possible.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*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.

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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.