Medication info
Romitel Tablet 40/5 mg (Telmisartan, Rosuvastatin Calcium)

Romitel Tablet 40/5 mg (Telmisartan, Rosuvastatin Calcium)

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

MFDS item code 202005526 · Approved 2020.07.29

Summary

Main use
Treatment of hypertension and hyperlipidemia (reduction of cardiovascular disease risk)
Who takes it
Adults
Adult dose
Telmisartan 1. Essential Hypertension Adults: It is recommended to orally take 40 mg of Telmisartan once daily, which may be effective at 20 mg once daily depending on the patient. If necessary, the dosage can be increased up to 80 mg once daily. 2. Reduction of Cardiovascular Disease Risk Adults: It is recommended to orally take 80 mg of this medication once daily. 3. Patients with Liver Dysfunction For mild to moderate liver dysfunction

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

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

  • Essential hypertension
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • abnormal beta-lipoproteinemia
  • elevated 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. Telmisartan helps to reduce the risk of death from cardiovascular diseases such as myocardial infarction and stroke, primarily in patients with hypertension and those over 55 years of age at high risk of cardiovascular disease. Rosuvastatin is used in patients with hypercholesterolemia and dyslipidemia when diet and exercise alone are insufficient, lowering total cholesterol and LDL cholesterol levels to delay the progression of atherosclerosis. Additionally, Rosuvastatin helps to reduce the risk of stroke, myocardial infarction, and vascular reintervention in high-risk patients with cardiovascular disease. The combination of these two medications is effective in preventing and managing the occurrence of cardiovascular diseases.

How to take

Adult dose

Telmisartan 1. Essential Hypertension Adults: It is recommended to orally take 40 mg of Telmisartan once daily, which may be effective at 20 mg once daily depending on the patient. If necessary, the dosage can be increased up to 80 mg once daily. 2. Reduction of Cardiovascular Disease Risk Adults: It is recommended to orally take 80 mg of this medication once daily. 3. Patients with Liver Dysfunction For mild to moderate liver dysfunction

Precautions

This medication can cause serious harm or death to the fetus or newborn during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Individuals who are allergic to this medication or its components, pregnant or potentially pregnant women, breastfeeding women, and those with severe liver dysfunction or bile excretion disorders should not take this medication. Those at high risk of myopathy or rhabdomyolysis should avoid high doses of this medication, and caution is required in individuals with a family history of muscular diseases, alcohol abuse, or concomitant medications that pose risk factors. Elderly patients, patients with hyperkalemia, liver dysfunction, and cardiovascular disease must take this medication with caution, and regular monitoring of liver function and muscle status is essential. This medication can cause symptoms such as muscle pain, weakness, and cramps, so if these symptoms occur, immediate consultation with a doctor is advised. Interactions may occur with other antihypertensive agents, lipid-lowering medications, certain antibiotics, and immunosuppressants, so it is important to inform the physician of any other medications being taken. Women who are pregnant or breastfeeding should not use this medication, and women who could become pregnant should use appropriate contraception. Safety in children and adolescents has not been established, so it is not recommended for this population. In case of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, so immediate medical attention should be sought. This medication can cause dizziness or drowsiness, so caution is advised when driving or operating hazardous machinery. This medication should be kept out of reach of children, and it is recommended not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, high fever, severe rash, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes, severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output,

Mild side effects

  • Headache
  • orthostatic dizziness
  • sleep paralysis
  • elevated blood pressure
  • decreased diastolic blood pressure
  • hypotension
  • ALT elevation
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
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  • lung diseases
  • unspecified gastrointestinal diseases
  • benign gastrointestinal tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • polyuria
  • tinnitus
  • hearing loss
  • halitosis
  • 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 may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to keep the storage temperature between 1°C and 30°C to safely maintain the effectiveness of the medication.

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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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.