Lipstar Plus Tablet 10/5 mg (Ezetimibe, Rosuvastatin Calcium)

Adult dose

This medication should be taken once daily, regardless of meals. For the treatment of primary hypercholesterolemia, an initial dose of 10/5 mg per day is recommended, and may be adjusted from 10/5 mg to 10/20 mg per day according to patient condition. After starting treatment or adjusting the dose, lipid levels should be confirmed with intervals of at least 4 weeks, and the dose adjusted accordingly. A maximum dose of 10/20 mg per day may be increased.

This drug may cause rhabdomyolysis, a rare side effect that can lead to muscle damage, and acute renal failure; therefore, patients experiencing severe muscle pain or weakness should immediately inform their doctor and discontinue treatment. This drug should not be used in patients with allergies to the active ingredients or components, those with liver disease or unexplained persistent increases in liver enzymes, those with muscle disorders, patients taking certain immunosuppressants, patients with severe renal impairment, pregnant women or women who may become pregnant, and nursing mothers. In particular, high doses of this drug are contraindicated in patients at risk for muscle disorders, such as those with moderate to severe kidney dysfunction, hypothyroidism, family history of muscle disorders, history of muscle side effects with other statins or fibrates, alcoholics, and Asian patients; caution is required. Patients taking this drug should have regular liver function tests, and if symptoms of liver damage or persistently elevated liver enzymes occur, dose adjustment or discontinuation may be necessary. If symptoms like muscle pain, cramps, and weakness occur, consult a doctor immediately and check for muscle damage through blood tests, and discontinue treatment in severe cases. This drug may interact with other medications; therefore, caution is needed, especially when used with anticoagulants, fibrate drugs, certain antibiotics, antifungals, immunosuppressants, etc., and patients should inform their doctor or pharmacist of any medications they are taking. Pregnant or nursing women should not take this medicine, and fertile women should use appropriate contraception. Elderly patients or those with impaired renal function have a higher risk of muscle damage, hence they need more careful monitoring during medication. This drug has not been established as safe or effective in children and is not recommended. In case of overdose, there is no specific antidote; hence treatment should be symptom-based, and liver function and muscle enzyme tests should monitor the patient's condition. Store this drug out of reach of children and do not transfer it to another container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain of oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), severe fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary symptoms

Mild side effects

• Increased ALT
• increased AST
• gastroesophageal reflux disease
• dizziness
• pruritus
• increased CPK
• sensory impairment
• low back pain
• headache
• asthenia

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to keep it at room temperature between 1°C and 30°C, away from extremes of temperature.

Appearance

White oval film-coated tablet

Package unit

30 tablets (10 tablets x 3)/Alu-Alu