Rosuvastatin Calcium and Ezetimibe Tablet 10/20 mg

Adult dose

This medication is taken once daily, regardless of meals. The dosage range is from 10/5 mg to 10/20 mg daily, with an initial dose of 10/5 mg recommended. In patients requiring greater reduction in LDL cholesterol, the dosage may be adjusted. After starting the medication or adjusting the dosage, lipid levels should be checked at intervals of 4 weeks or more, and the dose may be increased up to a maximum of 10/20 mg daily.

This medication may rarely cause muscle damage, leading to muscle pain or, in severe cases, a condition called rhabdomyolysis. This could result in acute kidney failure; therefore, if symptoms such as muscle pain, cramps, or weakness occur, immediate consultation with a physician is required. Particular caution is needed in patients with risk factors for muscle damage, such as severe infections, hypotension, major surgery, trauma, hypothyroidism, or reduced kidney function. It should not be administered to patients with poor liver function or active liver disease, and if liver function tests consistently show abnormalities, the treatment should be discontinued or adjusted. Additionally, this medication should not be used by pregnant women or those who could become pregnant, nor by breastfeeding mothers, and females of childbearing age should use effective contraception while taking this medication. It should also not be administered to patients with certain genetic lactose intolerance. Caution should be exercised for elderly patients, those with a history of alcoholism, liver disease, or reduced kidney function when administering this medication. This medication may interact with other medications, particularly fibrates, cyclosporine, anticoagulants, and certain antibiotics; therefore, caution is necessary when using in combination. Regular liver function and muscle-related tests should be conducted during use, and it is essential to inform healthcare providers of any abnormal symptoms. Symptoms such as dizziness or headache may occur, so care should be taken when driving or operating machinery. This medication has not been established for safety and efficacy in children and is not recommended for use in this group. In case of an overdose, no specific antidote is available, and treatment and supportive therapy based on symptoms are needed, along with liver function and muscle enzyme testing. This medication should be kept out of reach of children, and transferring it to other containers should be avoided.

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, altered consciousness.

Mild side effects

• Headache
• arthralgia
• dizziness
• fatigue
• constipation
• nausea
• abdominal pain
• diarrhea
• pruritus
• myalgia

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius to ensure the medication's effectiveness.

Appearance

This medication is a pink, rectangular film-coated tablet.

Package unit

30 tablets/box [10 tablets/PTP (Alu-Alu) x 3]