Medication info

Telmisartan and Rosuvastatin Tablets 40/5 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 202001856 · 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This product's status changed to Approval withdrawn on 2024.04.09.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
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, the recommended dose for adults is 40 mg orally once daily, which may be effective at 20 mg once daily in some patients. If needed, the dose may be increased up to 80 mg once daily. For the purpose of reducing cardiovascular disease risk, 80 mg orally once daily is recommended. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Primary hypercholesterolemia...

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
View approved original text

This medicine is used for patients who need to take telmisartan and rosuvastatin simultaneously. Telmisartan helps treat essential hypertension and reduce the risk of cardiovascular diseases. In particular, it reduces the risk of myocardial infarction and stroke in high-risk cardiovascular patients where ACE inhibitors cannot be used. Rosuvastatin is effective in treating hypercholesterolemia and dyslipidemia and is used as an adjunct when dietary management and exercise are insufficient. Additionally, it helps reduce the risk of cardiovascular diseases and slow the progression of atherosclerosis, thereby reducing the risk of stroke and myocardial infarction. This medication is used to improve cardiovascular health and reduce risks.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended dose for adults is 40 mg orally once daily, which may be effective at 20 mg once daily in some patients. If needed, the dose may be increased up to 80 mg once daily. For the purpose of reducing cardiovascular disease risk, 80 mg orally once daily is recommended. Patients with liver impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Primary hypercholesterolemia...

Precautions

This medication can cause serious harm to the fetus and newborn if used during pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Individuals allergic to this medication or its components, women who are pregnant or may become pregnant, and breastfeeding individuals should avoid using it. Patients with severe liver function impairment or bile flow issues, those with muscle diseases, and patients with severe renal dysfunction should not use this medication. Elderly patients or those with high blood potassium levels, and patients with slightly impaired liver function should exercise special caution when using this medication. This medication can cause muscle pain, muscle weakness, and rarely severe muscle damage, so if any unusual symptoms occur in the muscles while taking this medication, consult a doctor immediately. As liver function abnormalities may occur, it is important to undergo liver function tests before and during treatment. This medication may interact with other drugs; thus, current medications should be disclosed to a doctor or pharmacist. Overdose may present with symptoms such as hypotension, dizziness, or acute renal failure, requiring immediate medical attention. Dizziness or drowsiness may occur while driving or operating machinery; caution is advised. Keep this medication out of reach of children and do not transfer it to another container.

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 oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • increased blood pressure
  • hypotension
  • ALT elevation
  • dysuria
  • rhinitis
  • discomfort in the pharynx
  • lung disease
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  • unspecified gastrointestinal disease
  • benign gastrointestinal neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • abdominal pain
  • diarrhea
  • stool

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and safety for prolonged use.

Appearance and packaging

Appearance

Bright pink 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.

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.