Medication info

Telmisartan and Rosuvastatin Tablets 40/10 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Bright blue oval film-coated tablets
Packaging
30 tablets/box[(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202001857 · Approved 2020.03.17

This product's status changed to Approval withdrawn on 2024.04.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of (hypertension, cardiovascular disease risk) and improvement of (hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: For the treatment of essential hypertension, a recommended oral dose is 40 mg once daily, and in some patients, 20 mg once daily may also be effective. If necessary, the dose may be increased up to 80 mg once daily. To reduce the risk of cardiovascular diseases, it is recommended to take 80 mg orally once daily. For patients with liver impairment, the dose should not exceed 40 mg once daily. Rosuvastatin Calcium: For primary hypercholesterolemia...

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Reduction of (hypertension, cardiovascular disease risk) and improvement of (hypercholesterolemia)

  • Essential hypertension
  • coronary artery disease
  • peripheral arterial disease
  • stroke
  • transient ischemic attack
  • 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 used for patients who require simultaneous administration of Telmisartan and Rosuvastatin. Telmisartan is primarily used to treat essential hypertension and plays a role in reducing the risk of myocardial infarction, stroke, and mortality due to cardiovascular diseases in patients at high risk for cardiovascular events. Rosuvastatin Calcium is used as an adjunct in patients with hypercholesterolemia and dyslipidemia when not controlled by diet and exercise, lowering total cholesterol and LDL cholesterol, and delaying the progression of atherosclerosis. It also helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in patients at high cardiovascular risk. By using these two medications together, both hypertension and cholesterol issues can be simultaneously improved.

How to take

Adult dose

Telmisartan: For the treatment of essential hypertension, a recommended oral dose is 40 mg once daily, and in some patients, 20 mg once daily may also be effective. If necessary, the dose may be increased up to 80 mg once daily. To reduce the risk of cardiovascular diseases, it is recommended to take 80 mg orally once daily. For patients with liver impairment, the dose should not exceed 40 mg once daily. Rosuvastatin Calcium: For primary hypercholesterolemia...

Precautions

This medication can cause serious harm to a fetus during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Patients with a history of allergic reactions to this drug, pregnant or breastfeeding women, and fertile women not using appropriate contraception should not take this medication. Caution is advised when prescribing this drug to patients with severe liver impairment, biliary excretion issues, muscle disorders, or severe renal dysfunction, as it may be dangerous. Elderly patients, those with high potassium levels, patients with mildly impaired liver function, and those with heart or vascular diseases should use this medication cautiously. This medication can cause muscle pain, muscle weakness, and, rarely, severe muscle damage (rhabdomyolysis), so patients should consult a doctor immediately if muscle pain or weakness occurs during use. Liver function tests should be performed regularly before and during use of this medication as liver function abnormalities may occur. There may be interactions with other medications, so it is essential to inform the doctor or pharmacist about any other medications currently being taken. Excessive alcohol consumption should be avoided while taking this medication, and it is important to regularly monitor health conditions. Caution should be exercised when driving or operating dangerous machinery, as drowsiness or dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory problems with cough and fever, yellowing of skin or eyes (jaundice), extreme tiredness, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

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

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. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. This will help to preserve the drug's effectiveness over time.

Appearance and packaging

Appearance

Bright blue oval film-coated tablets

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.

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.