Rosuvastatin Calcium/Ezetimibe 10/10 mg

Adult dose

This medication is administered once daily regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. The initial dosage of 10/5 mg is recommended. For patients requiring more LDL cholesterol reduction, the dose may be adjusted. After starting treatment or adjusting the dose, lipid levels should be checked at intervals of 4 weeks or more, and the daily maximum may be increased to 10/20 mg.

This medication has been reported to cause rare but serious muscle-related issues. There is a risk of acute muscle injury accompanied by renal dysfunction, so if serious muscle pain or weakness occurs, patients should inform their doctor immediately. This medication should not be administered to certain patients, including those allergic to the active ingredients or components, those with severely impaired liver function, muscle diseases, severe renal failure, pregnant or nursing women should not take it. Additionally, caution is advised for patients with moderately impaired renal function, those with hypothyroidism, family history of muscle disorders, or those who have previously experienced a muscle toxic reaction, alcoholics, or those taking specific medications concurrently. Patients should undergo regular liver function and muscle enzyme tests during treatment, and consult their doctor immediately if there are signs of liver dysfunction or muscle-related symptoms. This medication should be avoided in patients with a history of liver disease or elevated liver enzyme levels, and treatment should be discontinued if symptoms of liver damage appear. Pregnant or potentially pregnant women should avoid this medication and proper contraceptive methods should be used during treatment. Nursing mothers should also avoid using this medication. The safety of this medication in children and adolescents has not been adequately established, so it is not recommended, and caution is needed in the elderly due to an increased risk of myopathy. There is a potential for interactions with other medications, so patients taking other medications should notify their physician or pharmacist. In case of overdose, there is no specific antidote, and appropriate treatment and supportive care based on symptoms are required, along with monitoring liver function and muscle enzyme levels. Finally, this medication should be kept out of the reach of children, and transferring it to other containers can compromise its quality, so care should be taken.

Serious side effects

• Urticaria, angioedema (severe swelling), cold sweat, chest discomfort, difficulty breathing, severe allergic reactions
• Severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe cutaneous reactions
• Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS)
• Respiratory issues: shortness of breath or difficulty breathing, asthma attacks, coughing accompanied by fever
• Liver abnormalities: skin or

Mild side effects

• Pharyngitis
• arthralgia
• headache
• dizziness
• upper respiratory infection
• myalgia
• rash
• pruritus
• weakness
• abdominal pain

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture. It is also safest to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets (15 tablets/PTP × 2)