Ezetimibe/Simvastatin 10/10 Tablets

Adult dose

This medicine is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with a generally recommended starting dose of 10/20 mg daily. Patients with less need for LDL-cholesterol reduction may start with 10/10 mg daily. For patients with homozygous familial hypercholesterolemia, the recommended dose is 10/40 mg daily.

This medicine may pose a risk of myopathy or rhabdomyolysis. This risk may be higher when taking higher doses of this medicine or in combination with other medications. It should not be administered to patients with any allergy to its components or severely impaired liver function, or to pregnant or breastfeeding women. During use, if symptoms such as muscle pain, muscle weakness, or unexplained muscle discomfort occur, medical personnel should be notified immediately. Additionally, this medicine may affect liver function; hence, patients with liver disease or elevated liver function test results should consult a physician before use. This medicine can interact with several other drugs; especially when taken with drugs that interfere with hepatic drug metabolism, the risk of muscle-related side effects may increase, so it is important to inform of any other medications being taken. Pregnant women or those who may become pregnant should not take this medicine, and if pregnancy is confirmed, use should be discontinued immediately. Nursing women should also not take this medicine and should discontinue breastfeeding if necessary. The safety and efficacy of this medicine have not been sufficiently proven in children and adolescents, hence caution is required during use. Elderly patients may respond differently to the medication, so caution is required during use. Regular blood tests to monitor liver function and muscle enzyme levels are recommended during use. There is no specific antidote for overdose, so it is crucial to avoid overdosing and consult medical staff immediately if problems arise.

Serious side effects

Urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in oral or ocular mucosa, yellowing of skin or eyes (jaundice), profound malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe swelling throughout the body accompanied by elevated blood pressure.

Mild side effects

• Headache
• diarrhea
• influenza
• upper respiratory tract infection
• muscle pain
• limb pain
• fatigue
• abdominal pain
• pharyngitis
• sinusitis

This medicine is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid storing in excessively hot or cold places, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White to pale yellow, biconvex, rectangular tablets

Package unit

30 tablets/PTP [(10 tablets/PTP X 3)]