Rosduo Tablet 10/10 mg

Adult dose

This medication should be administered once daily, regardless of meals. The recommended initial dose for primary hypercholesterolemia is 10/5 mg once daily. The dosage range is from 10/5 mg to 10/20 mg once daily, and the dose can be adjusted if a greater reduction in LDL cholesterol is needed. Lipid levels in the blood should be checked at intervals of more than 4 weeks after starting the administration or adjusting the dose, and the maximum dosage can be increased to 10/20 mg once daily.

This medication may cause a rare side effect known as rhabdomyolysis, which can lead to severe muscle damage. Therefore, treatment should be immediately discontinued if symptoms of acute myopathy appear. This medication should not be administered to patients with certain diseases or risk factors. For example, patients with liver disease or persistently elevated liver enzyme levels of unknown origin, myopathy patients, patients with severe renal failure, pregnant women or women who may become pregnant, and those with certain genetic lactose metabolism disorders should not use this medication. Patients with alcohol addiction, impaired liver function, elderly patients, and those with hypothyroidism, who are at high risk of myopathy should use this medication cautiously and require regular monitoring. While taking this medication, if symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, or fever appear, patients must immediately inform their doctor and undergo examinations. If blood tests reveal that CPK levels, which indicate muscle damage, rise more than five times the normal upper limit, the use of this medication should be discontinued. Since this medication may affect liver function, liver enzyme tests should be conducted before and during treatment, and if symptoms of liver damage appear, this medication should be discontinued immediately. Women who are pregnant or breastfeeding should not take this medication, and fertile women should use appropriate contraceptive methods while taking it. This medication may interact with other drugs, so any current medications should be disclosed to a doctor or pharmacist. Special caution is needed when used in combination with certain antibiotics, antifungals, immunosuppressants, anticoagulants, and fibrate drugs. Safety in children and adolescents has not been sufficiently confirmed; therefore, it is not recommended for pediatric use. Caution is advised when driving or operating machinery while taking this medication, as dizziness may occur.

Serious side effects

• Urticaria
• edema
• chest tightness
• chest discomfort
• cold sweat
• rhabdomyolysis
• severe edema
• myocardial ischemia
• elevated blood pressure
• kidney failure

Mild side effects

• Pharyngitis
• dyspepsia
• ALT elevation
• edema
• myalgia
• headache
• dry mouth
• liver enzyme elevation
• abnormal liver function tests
• increased serum lactate dehydrogenase

This medication should be stored in a sealed container to prevent exposure to air or moisture, and at a safe temperature between 1 to 30 degrees Celsius. Storing it in this manner can help maintain its effectiveness for a longer time.

Appearance

Yellow rectangular film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 3)], 30 tablets/bottle