Medication info
Romitel Tablets 80/5mg (Telmisartan, Rosuvastatin Calcium)

Romitel Tablets 80/5mg (Telmisartan, Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
Light pink oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 202005523 · Approved 2020.07.29

Summary

Main use
Improvement of hypertension and hypercholesterolemia, 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 a day, which may be effective at 20 mg in some patients. If necessary, the dose may be increased to 80 mg once daily. For the purpose of reducing cardiovascular disease risk, an oral dose of 80 mg once daily is recommended. Patients with hepatic impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Primarily...

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Improvement of hypertension and hypercholesterolemia, reduction of cardiovascular disease risk

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

This medication is used for patients who need to take both telmisartan and rosuvastatin. Telmisartan is mainly used for the treatment of essential hypertension and helps reduce the risk of myocardial infarction, stroke, and cardiovascular mortality in patients at high risk for cardiovascular disease. Rosuvastatin is used to lower blood cholesterol levels in patients with hypercholesterolemia or dyslipidemia, slowing the progression of atherosclerosis and reducing the risk of cardiovascular disease. Since both medications play vital roles in the prevention and treatment of cardiovascular diseases, they are appropriate treatment options for patients at high risk for these conditions. In conclusion, this medication is used to improve the condition of patients at risk for cardiovascular disease associated with hypertension and dyslipidemia.

How to take

Adult dose

Telmisartan: For essential hypertension, the recommended dose for adults is 40 mg orally once a day, which may be effective at 20 mg in some patients. If necessary, the dose may be increased to 80 mg once daily. For the purpose of reducing cardiovascular disease risk, an oral dose of 80 mg once daily is recommended. Patients with hepatic impairment should not exceed 40 mg once daily. Rosuvastatin Calcium: Primarily...

Precautions

This medication may cause serious harm to the fetus and newborn if taken during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Individuals who are allergic to this medication or its components, women who are pregnant or may become pregnant, or those who are nursing should not take this medication. Patients with severely impaired liver function, obstructive biliary disease, or cholestasis should avoid taking this medication, as the components may not be excreted properly from the body. Patients with muscle diseases or those who have previously experienced muscle-related side effects, as well as individuals with severe renal impairment, should not take this medication. Individuals with genetic problems such as lactose intolerance should also refrain from taking this medication. Elderly patients or those with high potassium levels in their blood, as well as patients with mild liver impairment, should exercise caution when taking this medication and should have their liver function tests and potassium levels checked regularly. If symptoms of muscle pain or weakness occur, patients should consult a physician immediately, and muscle enzyme tests should be performed if necessary. This medication may interact with other antihypertensives, lipid-lowering agents, certain antibiotics, immunosuppressants, and so on, so patients should inform their doctor of all medications they are currently taking. Also, as this medication may affect liver and kidney function, it is important to have regular blood tests to monitor these functions. Caution is advised when driving or operating machinery, as dizziness or drowsiness may occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue all over the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • blood pressure increase
  • diastolic blood pressure decrease
  • hypotension
  • dysuria
  • rhinitis
  • oropharyngeal discomfort
  • pulmonary diseases
Show 23 more
  • unspecified gastrointestinal diseases
  • benign gastrointestinal tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • increased frequency of urination
  • tinnitus
  • hearing loss
  • halitosis
  • 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 should be stored in a tightly sealed container to prevent exposure to air or moisture, and it should be kept at room temperature, between 1 and 30 degrees Celsius. Therefore, it is advisable to avoid storage in excessively cold or hot places and to keep it in a cool place out of direct sunlight.

Appearance and packaging

Appearance

Light pink 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.