Rozetam tablet 10/20 milligrams

Adult dose

This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dose ranges from 10/5mg to 10/20mg daily, with the recommended starting dose being 10/5mg per day. The dose can be adjusted for patients requiring greater reductions in LDL-cholesterol. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of at least 4 weeks, and the dose adjusted accordingly.

This medication can cause a rare side effect known as rhabdomyolysis, which can lead to severe muscle problems. This poses a risk of acute kidney function deterioration, so if serious muscle pain or weakness occurs, immediate consultation with a doctor is necessary. Additionally, this medication can affect liver function. Patients with liver disease or those with abnormally high liver enzyme levels should not use it. If symptoms of liver dysfunction occur, treatment should be halted immediately, and medical attention should be sought. This medication should not be administered to patients with certain muscle diseases or those taking specific medications such as cyclosporine, patients with severe kidney dysfunction, and women who are pregnant or breastfeeding. Patients with a history of alcohol abuse or liver disease, elderly patients, and those with hypothyroidism, who are at higher risk for muscle problems should use this medication cautiously and have regular muscle and liver function tests. During the use of this medication, if symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, heat sensation, etc., appear, immediate notification to a doctor is essential, and blood tests may be needed to check for muscle damage. Women of childbearing potential should use appropriate contraceptive methods while taking this medication, and if pregnancy is confirmed, the medication should be stopped immediately. Breastfeeding women are also advised against taking this medication. Furthermore, this medication can interact with other drugs. Patients taking other medications must inform their doctor or pharmacist. Caution is particularly required when combined with warfarin, fibrates, certain antibiotics, and antifungals. Safety in children and adolescents has not been sufficiently established, so it is not recommended for children under 10 years of age. During the use of this medication, caution is necessary as dizziness may occur while driving or operating machinery. Lastly, this medication should be kept out of the reach of children and should not be transferred to another container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination issues

Mild side effects

• Pharyngitis
• arthralgia
• headache
• elevated ALT
• elevated AST
• myalgia
• edema
• elevated serum bilirubin
• acneiform dermatitis
• pruritus

This medication should be stored in a tightly closed container to protect it from air and moisture, and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its effectiveness and prevent deterioration.

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP X 3]