Rosuvastatin Calcium/Ezetimibe Tablet 10/5 mg

Adult dose

This drug is administered once daily without regard to meals. For primary hypercholesterolemia, an initial dose of 10/5 mg daily is recommended. In patients requiring a greater reduction in LDL-cholesterol, the dosage may be adjusted accordingly. Lipid levels should be checked at intervals of at least 4 weeks after starting treatment or after dose adjustment for monitoring and dosage modification. The maximum daily dose can be increased to 10/20 mg.

This drug can rarely cause rhabdomyolysis, which might severely damage muscle tissues and impair kidney function, so any sudden muscle pain or weakness symptoms should prompt immediate consultation with a physician. Since this drug may affect liver function, a liver function test should be conducted before administration, and liver function should be regularly monitored during treatment. This drug should not be administered to patients with specific liver diseases or severe kidney function impairment, and it is also contraindicated for pregnant women, women who may become pregnant, and nursing mothers. Caution should be exercised when this drug is used in patients with a history of alcohol abuse, hypothyroidism, genetic muscle disorders, elderly patients, and when co-administered with certain other medications, where dosage adjustments and monitoring according to a physician's instructions may be needed. This drug may cause side effects such as muscle pain, dyspepsia, headache, dizziness, elevated liver enzyme levels, etc., and if these symptoms persist or worsen, medical personnel should be informed. Furthermore, as this drug may interact with other medications, it is crucial to inform healthcare providers of any other medications being taken, especially anticoagulants, fibrates, and some antibiotics and antifungals when used in conjunction. The safety and efficacy of this medication have not been fully established in children and adolescents and the elderly, so special caution is required. During the use of this drug, intense exercise or activities that strain the muscles should be avoided, and if muscle pain or weakness symptoms occur, immediate medical attention should be sought. This drug should be kept out of reach of children and should not be stored in an arbitrary container.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty catching breath, asthma attack, respiratory distress with cough + fever, jaundice (yellowing of the skin or eyes), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urinary issues

Mild side effects

• Headache
• dizziness
• dyspepsia
• edema
• muscle pain
• chest discomfort
• pruritus
• nausea
• abdominal pain
• diarrhea

This drug must be stored in a tightly sealed container to prevent air and moisture exposure. It is important to maintain a room temperature between 1 to 30 degrees Celsius while storing, as this helps preserve the drug's efficacy for a longer period.

Appearance

Pink rectangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3), 100 tablets/bottle