Simvastatin/Ezetimibe Tablet 10/20 mg

Adult dose

This medicine is taken 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. The generally recommended initial dose is 10/20 mg once daily. For patients who need less reduction in LDL cholesterol, treatment may begin with 10/10 mg daily. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of more than 4 weeks.

This medicine may cause muscle-related diseases, including myopathy or rhabdomyolysis. The risk of this occurring may be increased when taking high doses of this medicine or in combination with certain other medications. Therefore, if symptoms such as muscle pain, muscle weakness, or unexplained muscle symptoms occur, it is essential to consult a doctor immediately. This medicine is not administered to patients allergic to the components or those with active liver diseases, nor to pregnant or breastfeeding women. During pregnancy, the synthesis of cholesterol necessary for normal fetal development may be inhibited, posing a risk; therefore, use should be avoided. Additionally, this medicine should not be combined with certain potent liver enzyme inhibitors, fibrate medications, some antibiotics, and antiviral drugs due to the risk of severe side effects. Elderly patients or those with impaired liver function or severe myasthenia gravis should use this medicine cautiously and may require regular monitoring. During the use of this medicine, regular liver function tests and muscle-related tests should be conducted, and any abnormal symptoms should be reported to a healthcare professional immediately. Women who may become pregnant should avoid pregnancy while taking this medication and must stop it immediately upon confirmation of pregnancy. Breastfeeding women are also advised to discontinue breastfeeding while taking this medicine for safety. For children and adolescents, caution is required as the safety and efficacy of this medicine have not been thoroughly studied. When starting new medications while taking this medicine, it is crucial to inform healthcare providers about its use, and it is advisable to avoid certain foods such as grapefruit juice. In case of overdose, there is no specific antidote; treatment will be symptomatic based on the symptoms. To use this medicine safely, it is necessary to strictly follow the doctor's instructions and consult a specialist immediately if any unusual symptoms occur.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), feeling extremely lethargic, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination issues

Mild side effects

• Headache
• diarrhea
• influenza
• upper respiratory tract infection
• muscle pain
• limb pain
• fatigue
• nausea
• abdominal pain
• constipation

This medicine is sensitive to air and moisture; therefore, the bottle must be tightly closed for storage. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

White to off-white, double convex elongated tablets

Package unit

30 tablets [(10 tablets/PTP) × 3]