Medication info
Romitel Tablets 80/10 mg (Telmisartan, Rosuvastatin Calcium)

Romitel Tablets 80/10 mg (Telmisartan, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
Bright blue oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 202005525 · Approved 2020.07.29

Summary

Main use
Treatment for reducing the risk of (hypertension, hyperlipidemia) and cardiovascular diseases
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension in adults, it is recommended to take 40 mg orally once daily; a 20 mg dose may be effective for some patients. If necessary, the dose can be increased to 80 mg once daily. For reducing cardiovascular disease risk, it is recommended to take 80 mg orally once daily. Patients with liver dysfunction: Caution should be taken to not exceed 40 mg once daily in patients with mild to moderate liver dysfunction.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Treatment for reducing the risk of (hypertension, hyperlipidemia) and cardiovascular diseases

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used for patients who need to take both Telmisartan and Rosuvastatin simultaneously. Telmisartan helps to lower blood pressure and reduces the risk of cardiovascular mortality, such as myocardial infarction and stroke, especially in elderly patients at high risk for cardiovascular diseases. Rosuvastatin helps control cholesterol levels in the blood, slowing the progression of atherosclerosis and reducing the risk of cardiovascular diseases. Therefore, the combination of these two medications is effective in improving cardiovascular health in patients with both hypertension and hyperlipidemia. This medication is used for the prevention and treatment of cardiovascular diseases.

How to take

Adult dose

Telmisartan: For essential hypertension in adults, it is recommended to take 40 mg orally once daily; a 20 mg dose may be effective for some patients. If necessary, the dose can be increased to 80 mg once daily. For reducing cardiovascular disease risk, it is recommended to take 80 mg orally once daily. Patients with liver dysfunction: Caution should be taken to not exceed 40 mg once daily in patients with mild to moderate liver dysfunction.

Precautions

This medication can cause serious harm to the fetus during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Pregnant women, nursing mothers, and women who may become pregnant should not take this medication, and appropriate contraceptive methods should be used. It should not be administered to patients with severe liver or kidney dysfunction, specific liver diseases, or muscle diseases. Special care is needed for the elderly, patients with hyperkalemia, and those with impaired liver or kidney function when using this medication. If symptoms such as muscle pain or weakness occur, it is essential to consult a doctor immediately, and in severe cases, discontinuation of the medication may be necessary. This medication may affect liver function, so regular liver function tests should be conducted. As a blood pressure-lowering agent, symptoms such as hypotension, dizziness, and syncope may occur, requiring caution. Interactions with other medications may occur, so it is crucial to inform the doctor or pharmacist of any other medications being taken. Caution is advised as dizziness or drowsiness may occur while driving or operating machinery. Keep 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, angioedema, 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, asthma attacks, respiratory distress associated with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances,

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleepiness
  • increased blood pressure
  • hypotension
  • elevated ALT
  • pain during urination
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary disease
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  • unspecified gastrointestinal disease
  • benign gastric tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath
  • fatty liver
  • depression
  • insomnia
  • anxiety
  • syncope
  • visual disturbances
  • dizziness
  • bradycardia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • abdominal pain

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture, and it is crucial to maintain storage temperatures between 1 to 30 degrees Celsius. Storing it this way will help preserve the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Bright blue 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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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.