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Ezetimibe 10mg · Simvastatin 10mg
Tablet · Prescription medication · Combination
Hana Pharmaceutical Co., Ltd.

MFDS item code 201601728 · Approved 2016.03.31 · Insurance code 657805810
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
This medication is used as an adjunct to dietary therapy to reduce elevated total cholesterol, LDL-cholesterol, Apo B, and triglycerides, and to increase HDL-cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. It is also prescribed as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia or used alone when other treatments are not effective. It is administered along with appropriate dietary therapy to reduce the risk of atherosclerotic vascular diseases due to hypercholesterolemia and is used when there is insufficient response to non-drug therapy. It is important to identify secondary causes such as diabetes and hypothyroidism and treat them if necessary before administration. Regular lipid testing should be conducted during treatment to monitor total cholesterol, LDL, HDL, and triglyceride levels. This medication aids in improving dyslipidemia and preventing cardiovascular diseases.
This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg daily, with the generally recommended initial dose being 10/20 mg daily. Patients with a low need for LDL-cholesterol reduction may start with 10/10 mg daily. After starting treatment or adjusting the dose, blood lipid levels should be checked after an interval of more than 4 weeks.
This medication may cause muscle-related side effects such as myopathy or rhabdomyolysis, so notify a doctor immediately if muscle pain, weakness, or any unusual symptoms occur. Caution is especially needed when taking high doses or in combination with other medications, as these risks can be increased. Patients allergic to any component of this medication, with poor liver function, pregnant or breastfeeding women, and those taking specific medications (e.g., strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol) should not use this medication. Patients with muscle weakness or a history of muscle problems due to statin medications should use this medication with caution. There may be liver function abnormalities during use of this medication, so regular liver function tests are necessary, and patients with a history of liver disease should be especially cautious. In addition, there are several medications that may interact with this drug, so consult a doctor or pharmacist if taking other medications. Women who are pregnant or plan to become pregnant should not take this medication, and if pregnancy occurs during use, it should be discontinued immediately. It is also recommended that breastfeeding women stop breastfeeding while taking this medication. Special attention is required when administering to children or the elderly, as the safety and efficacy in pediatric patients have not been sufficiently proven. In the case of overdose, there is no specific antidote, so general treatment based on symptoms is necessary. This medication helps in the prevention of cardiovascular diseases, but patients at risk of diabetes should regularly check their blood sugar levels.
Hives, severe swelling (edema), chest discomfort, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination
Headache, diarrhea, influenza, upper respiratory infection, myalgia, limb pain, fatigue, nausea, abdominal pain, constipation, dizziness, paresthesia, depression, cholelithiasis, cholecystitis, itching, alopecia, thrombocytopenia, increased serum creatine phosphokinase (CPK), weight loss, edema, thirst, facial swelling, syncope, insomnia, gastritis, atrophic gastritis, dyspepsia, mucus stool, irritable bowel syndrome, sore throat, nocturia, hematuria,
Not everyone experiences these, and they can vary from person to person.
Store this medication in a tightly closed container to prevent exposure to air or moisture. It is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's effectiveness and ensure safe use.
Biconvex rectangular tablets, white to light yellow
30 tablets (10 tablets/PTP x 3)
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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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.
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For anything that needs medical judgment, consult a doctor or pharmacist.
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.