Medication info
Combiroze Tablets 10/5 mg

Combiroze Tablets 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Pink oblong film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP×3]
Approval status
Active

MFDS item code 202004571 · Approved 2020.06.23 · Insurance code 657203600

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily, with or without food. For primary hypercholesterolemia, treatment is started at 10/5 mg once daily and can be increased to 10/20 mg once daily as needed. Check lipid levels in the blood after starting treatment or adjusting the dosage, with at least a 4-week interval before each measurement.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL-cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used to lower total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels, and to raise HDL-cholesterol levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial hypercholesterolemia, and mixed dyslipidemia. It is primarily taken in conjunction with dietary therapy and is an adjunctive treatment when non-drug therapies, such as dietary restriction of saturated fats and cholesterol intake, are ineffective. Additionally, this medication helps lower the risk of atherosclerotic vascular disease due to hypercholesterolemia. Before use, secondary causes of dyslipidemia must be confirmed, such as diabetes, hypothyroidism, liver disease, and renal failure, and treatment should be combined as necessary. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be periodically checked to assess the effectiveness of the medication. Overall, this medication improves the risk of cardiovascular disease through the management of dyslipidemia.

How to take

Adult dose

This medication is administered once daily, with or without food. For primary hypercholesterolemia, treatment is started at 10/5 mg once daily and can be increased to 10/20 mg once daily as needed. Check lipid levels in the blood after starting treatment or adjusting the dosage, with at least a 4-week interval before each measurement.

Precautions

This medication can rarely cause muscle problems; if symptoms such as muscle pain, muscle cramps, or muscle weakness occur, consult a doctor immediately. This medication may affect liver function, so liver function tests should be performed before treatment and liver health should be regularly monitored during treatment. This medication should not be used in patients with certain liver diseases or undetermined elevated liver enzyme levels. It is safe not to administer this medication to patients with severely impaired kidney function. Women who are pregnant or might become pregnant, as well as nursing mothers, should not use this medication, and women of childbearing age should employ adequate contraception while taking this medication. This medication may interact with other drugs, so you must inform your doctor or pharmacist of any current medications you are taking. Patients who consume alcohol excessively or have a history of liver disease should use this medication cautiously, and patients at risk of myopathy also require attention. The use of this medication is not recommended or should be approached with caution in children and the elderly, so this must be considered. Dizziness or fatigue may occur while taking this medication, so caution is necessary when driving or operating machinery. This medication contains lactose, so patients with lactose intolerance should not use it. In case of overdose, you should visit a healthcare facility immediately for appropriate treatment, and liver function tests and muscle enzyme levels should be checked according to the symptoms.

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 high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • pruritus
  • indigestion
  • dry mouth
  • elevated blood sugar
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  • chest pain
  • cough
  • diarrhea
  • fatigue
  • weakness
  • sensory disturbances
  • rash
  • alopecia
  • chest discomfort
  • vomiting
  • abdominal bloating
  • epigastric discomfort
  • belching
  • gastrointestinal disturbances
  • nasal congestion
  • bronchitis
  • rhinitis
  • cystitis
  • tinea of toenails
  • soft tissue infections
  • loss of appetite
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction

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 humidity. Additionally, it is best stored at room temperature between 1°C and 30°C. Avoid places that are too hot or too cold.

Appearance and packaging

Appearance

Pink oblong 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.