Medication info
Eurowaset Tablets 10/5 mg

Eurowaset Tablets 10/5 mg

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

MFDS item code 202004558 · Approved 2020.06.23 · Insurance code 644503170

Summary

Main use
Improvement of lipid levels in primary hypercholesterolemia (familial, mixed) and dyslipidemia, and suppression of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. If more significant reduction of LDL cholesterol is required, the dosage can be adjusted. After starting administration or adjusting the dose, lipid levels should be checked at intervals of at least 4 weeks, and dosages will be adjusted accordingly, with a maximum daily dose of 10/20 mg.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Improvement of lipid levels in primary hypercholesterolemia (familial, mixed) and dyslipidemia, and suppression of the risk of atherosclerotic vascular diseases

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

This medication is used as an adjunct to diet to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to raise the good HDL cholesterol levels. It is particularly important to follow appropriate dietary therapy alongside lipid-lowering medication when there is a high risk of vascular disease due to atherosclerosis. This medication is administered in cases where non-pharmacological treatments, such as limiting saturated fats and cholesterol intake, have inadequate responses. Before treatment, it is essential to identify other causes of dyslipidemia, such as diabetes or hypothyroidism and treat them if necessary. Regular checks of cholesterol and triglyceride levels should be conducted during treatment for proper management, and the medication helps reduce cardiovascular disease risks through improvements in blood lipid levels.

How to take

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended. If more significant reduction of LDL cholesterol is required, the dosage can be adjusted. After starting administration or adjusting the dose, lipid levels should be checked at intervals of at least 4 weeks, and dosages will be adjusted accordingly, with a maximum daily dose of 10/20 mg.

Precautions

This medication can rarely cause severe muscle damage that may lead to kidney problems; therefore, if severe muscle pain or weakness occurs, immediate consultation with a physician is necessary. In particular, patients with severe infections, hypotension, major surgery or trauma, and serious metabolic abnormalities should stop or temporarily discontinue this medication. Patients allergic to any components of this medication, and those with liver disease, muscle disease, severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Additionally, patients with certain renal impairments, hypothyroidism, a family history of muscle disease, or a history of myotoxicity with other statins, alcoholics, and Asian patients who may be prone to muscle problems should use this medication with caution. This medication contains lactose, so it should not be administered to patients with lactose intolerance or related genetic disorders. Patients with impaired liver function or those who consume excessive alcohol should also exercise caution when using this medication. During the use of this medication, regular liver enzyme tests and muscle-related examinations should be conducted, and it is critical to report any abnormal symptoms to healthcare professionals immediately. This medication may interact with other drugs, so patients should inform their healthcare providers of any medications they are currently taking. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy is confirmed during treatment, it should be discontinued immediately. It is also advisable for breastfeeding women not to use this medication. Caution is needed for children and the elderly as the safety and efficacy of this medication have not been sufficiently established. In case of overdose, since there is no specific antidote, treatment should be based on symptoms, and monitoring of liver function and muscle condition is necessary. This medication should be kept out of the reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives, hypersensitivity reactions including angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • Severe rashes with high fever, blistering, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, eosinophilia, and drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin adverse reactions
  • Sudden and severe headaches, lightning headaches, seizures, confusion of consciousness

Mild side effects

  • Nasopharyngitis
  • indigestion
  • myalgia
  • headache
  • dizziness
  • itching
  • rash
  • weakness
  • fatigue
  • constipation
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  • nausea
  • abdominal pain
  • diarrhea
  • dry mouth
  • elevated blood lactate dehydrogenase
  • musculoskeletal discomfort
  • muscle weakness
  • arthralgia
  • limb pain
  • chest discomfort
  • chest pain
  • cough
  • loss of appetite
  • abdominal distension
  • vomiting
  • gastritis
  • tongue disorders
  • elevated blood pressure
  • thrombocytopenia
  • depression
  • tremor
  • drowsiness
  • paresthesia
  • cold sweat
  • alopecia
  • palpitations

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius. This helps to maintain the medication's efficacy and safety for a long time.

Appearance and packaging

Appearance

Pink rectangular 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.