Combiroze Tablet 10/20mg

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5mg daily is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dosage may be adjusted, with a maximum increase to 10/20mg daily. After initiation of treatment or adjustment of dosage, lipid levels should be checked at intervals of at least 4 weeks to adjust dosage.

This medication may rarely cause damage to muscle tissue, leading to severe kidney problems; thus, dosing should be temporarily halted or stopped in the presence of symptoms of acute myopathy or risk factors. It should not be used in patients with an allergy to any components of this medication, active liver disease, severe liver dysfunction, muscle disease, severe renal impairment, or in women who are pregnant or breastfeeding. Caution is particularly necessary for patients at high risk for muscle issues, those with a history of liver disease or alcohol abuse, older adults, and those taking certain medications concurrently. During treatment, if experiencing muscle pain, muscle weakness, fatigue, or fever, patients should immediately inform their physician for examination, and in severe cases, the medication must be discontinued. Liver function abnormalities may occur, so liver function tests must be conducted before and during treatment, and if liver enzyme levels rise significantly, dosage adjustment or discontinuation may be necessary. This medication may slightly elevate blood sugar levels; however, due to its greater effect on preventing vascular diseases, patients needing blood sugar management should be monitored regularly. It may interact with other medications, particularly anticoagulants, certain antibiotics, immunosuppressants, some antivirals, and fibrate class drugs; hence, caution is needed when co-administered. Women who are pregnant or may become pregnant should not take this medication and must use appropriate contraception while on it. Safety in children and adolescents has not been sufficiently established, so it is not recommended. Elderly patients or those with impaired liver or kidney function should have dosage adjustments and increased caution. There are no specific antidotes for overdose; therefore, treatment should be symptomatic, and liver function and muscle enzyme tests should be conducted.

Serious side effects

Hives, severe swelling (edema), chest tightness, cold sweats, paleness, rash, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing, respiratory issues, jaundice (yellowing of skin or eyes), generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly decreased urine output, generalized severe swelling with elevated blood pressure, myopathy, rhabdomyolysis

Mild side effects

Nasopharyngitis, dyspepsia, headache, itching, rash, myalgia, dizziness, constipation, nausea, abdominal pain, elevated blood sugar, increased blood lactate dehydrogenase enzyme, dry mouth, elevated liver enzymes, abnormal liver function tests, pruritis, thrombocytopenia, cough, diarrhea, chest discomfort, oropharyngeal pain, nasal congestion, osteoarthritis, osteoporosis, musculoskeletal stiffness, musculoskeletal discomfort, muscle weakness, dermatitis, burning sensation of the skin, alopecia, ear discomfort,

This medication must be stored in a tightly sealed container to avoid exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3]