Medication info
Romitel Tablet 40/10mg (Telmisartan, Rosuvastatin Calcium)

Romitel Tablet 40/10mg (Telmisartan, Rosuvastatin Calcium)

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

MFDS item code 202005528 · Approved 2020.07.29

Summary

Main use
Reduction of (hypertension, cardiovascular disease risk) and improvement of (hypercholesterolemia)
Who takes it
Adults
Adult dose
Telmisartan: For essential hypertension, an oral dose of 40 mg once daily is recommended, which may be effective at 20 mg in some patients. If necessary, the dose can 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 liver impairment: Caution is needed not to exceed 40 mg once daily for patients with mild to moderate liver impairment. Rosuvastatin Calcium: Primary

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

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

  • Essential hypertension
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used for patients who require both telmisartan and rosuvastatin at the same time. Telmisartan primarily helps manage high blood pressure and reduces the risk of cardiovascular disease. It plays a role in reducing the risk of myocardial infarction, stroke, and cardiovascular death, especially in patients over 55 years old who are at high risk for cardiovascular disease. Rosuvastatin manages hypercholesterolemia and dyslipidemia, and is used to slow the progression of atherosclerosis. Additionally, it has the effect of reducing the risk associated with stroke, myocardial infarction, and vascular interventions in adults at high risk for cardiovascular disease. Therefore, this medication is used effectively to improve the risk of cardiovascular disease.

How to take

Adult dose

Telmisartan: For essential hypertension, an oral dose of 40 mg once daily is recommended, which may be effective at 20 mg in some patients. If necessary, the dose can 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 liver impairment: Caution is needed not to exceed 40 mg once daily for patients with mild to moderate liver impairment. Rosuvastatin Calcium: Primary

Precautions

This medication can cause severe harm or even death to the fetus or newborn if taken during pregnancy, so it must be stopped immediately if pregnancy is confirmed. People who are allergic to this medication or its ingredients, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Patients with severely impaired liver function or problems with bile excretion, as well as those with unexplained elevations of liver enzymes, should also avoid this medication. Patients with muscle disorders or those who have previously experienced muscle-related side effects, severely impaired kidney function, or those taking specific immunosuppressants should avoid this medication. It is also not suitable for patients with genetic metabolic disorders such as lactose intolerance. Elderly patients, those with high potassium levels or impaired liver function, and patients with heart or kidney problems should take this medication with special caution and may require regular testing as directed by a physician. This medication can cause serious muscle-related side effects such as myalgia, muscle weakness, and rhabdomyolysis, so if muscle pain or weakness occurs during use, consult a doctor immediately. Various side effects such as liver function abnormalities, allergic reactions, low blood pressure, and gastrointestinal symptoms may occur; if any unusual symptoms develop, contact a healthcare professional. This medication may interact with other medications, so if the patient is taking other medicines, they must inform their doctor or pharmacist and seek consultation. It is safer for pregnant or breastfeeding women not to take this medication, and if planning to become pregnant, appropriate contraceptive measures should be employed. It is not recommended for children since safety and efficacy have not been established. In cases of overdose, symptoms such as low blood pressure, dizziness, and kidney function abnormalities may occur, so immediate medical attention should be sought. Drowsiness or dizziness may occur during use, so caution is needed when driving or operating dangerous machinery. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, difficulty or trouble breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowness of skin or eyes, jaundice, profound fatigue, liver abnormalities, sudden severe headache, thunderclap headache, seizures, confusion of consciousness,

Mild side effects

Headache, orthostatic dizziness, sleepiness, elevated blood pressure (systolic or diastolic), decreased diastolic blood pressure, hypotension, ALT elevation, painful urination, rhinitis, oral and pharyngeal discomfort, pulmonary disease, undetermined gastrointestinal disease, benign gastrointestinal neoplasm, hemorrhoids, skeletal pain, osteoporosis, sensory impairment, movement disorders, atherosclerosis, frequent urination, tinnitus, hearing loss, bad breath, fatty liver, depression, insomnia, anxiety, fainting, visual disturbances, dizziness,

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture, and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Light 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.