RotiBeul Tablet 10/10 mg

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dose range is from 10/5 mg to 10/20 mg per day. The initial dose recommended is 10/5 mg per day. Patients requiring greater LDL cholesterol reduction may have their dose adjusted, and lipid levels should be checked at intervals of 4 weeks or more before adjusting the dose. The maximum daily dose is 10/20 mg.

This medication contains the ingredients rosuvastatin and ezetimibe and is primarily used for the treatment of hypercholesterolemia. Before taking this medication, it should be confirmed whether there is a risk of muscle pain or myopathy, particularly serious muscle conditions such as rhabdomyolysis. If severe muscle pain or weakness occurs, accompanied by fever and muscle pain, the doctor should be notified immediately, and if necessary, muscle enzyme levels may be tested to halt dosing. For patients with poor liver function or a history of liver disease, liver function tests should be carried out periodically before and during the use of this medication, and dosing should be halted if liver enzyme levels rise significantly. This medication should not be used in patients with severely impaired kidney function, those with muscle disorders, pregnant women, or breastfeeding women. This medication may interact with other drugs, so caution is needed, especially when used in combination with cyclosporine, fibrate drugs, anticoagulants, and certain antibiotics. Appropriate monitoring should be undertaken after consulting a doctor when used in conjunction. This medication contains lactose, so patients with lactose intolerance should be cautious when taking it. Elderly patients or those with liver disease, kidney impairment, hypothyroidism, and alcohol use disorder need to be especially careful while taking this medication, and they should be administered as directed by a physician. Women who are pregnant or who may become pregnant must ensure appropriate contraception, and if pregnancy is confirmed, dosing should be discontinued immediately. While taking this medication, side effects such as headaches, dizziness, indigestion, muscle pain, increased liver enzymes, edema, and others may occur, so if symptoms are severe or persistent, consult a doctor. Safety in children and adolescents has not been sufficiently established, so this medication is not recommended for pediatric patients. Caution is required when driving or operating machinery as dizziness may occur.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, shortness of breath or difficulty in breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, consciousness confusion, visual disturbances, paralysis, urination issues

Mild side effects

Nasal pharyngitis, indigestion, headache, dizziness, constipation, nausea, abdominal pain, dry mouth, increased liver enzymes, abnormal liver function tests, elevated blood lactate dehydrogenase levels, itching, muscle pain, elevated blood sugar, increased blood CPK, chest discomfort, fatigue, weakness, sensory disturbances, nausea, diarrhea, loss of appetite, abdominal distension, fainting, generalized pain, muscle cramps, gout, erectile dysfunction, depression, lethargy, neurodegenerative disorders, orthostatic dizziness

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance

Yellow, rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle