Roset Tablet 10/10 mg

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, treatment begins at 10/5 mg once daily, and the dosage may be adjusted between 10/5 mg and 10/20 mg based on need. In patients requiring greater reductions in LDL cholesterol, the dosage may be increased, with a maximum daily dosage of 10/20 mg. When adjusting the dosage, intervals of more than 4 weeks should be maintained while monitoring serum lipid levels.

This medication can cause a rare side effect known as rhabdomyolysis, which may result in severe muscle problems. Consequently, acute renal failure may occur, so if severe muscle pain or weakness is experienced, medical consultation should be sought immediately. This medication should not be administered to patients with certain conditions. For example, individuals allergic to this drug, those with active liver disease, muscle disorders, severe renal failure, or women who are pregnant or breastfeeding should not take this medication. Patients with alcohol dependence, impaired liver function, the elderly, or those with hypothyroidism, all of whom are at increased risk for myopathy, should use this medication cautiously and require regular monitoring of muscle and liver function. This drug can place stress on the liver; therefore, dosage adjustments or discontinuation should occur if liver function tests yield abnormal results. Treatment should be discontinued immediately if symptoms such as hepatitis or jaundice appear. Blood glucose levels may increase while taking this medication, so patients at risk of diabetes should monitor their blood sugar regularly. Caution is required when used in conjunction with other medications. In particular, concomitant use with certain antibiotics, antifungals, immunosuppressants, anticoagulants, and fibrates may increase the risk of side effects from this medication, warranting consultation with a physician. Women who are pregnant or planning to become pregnant should not take this medication, and effective contraceptive methods should be used during treatment. It is also advisable that breastfeeding women refrain from using this drug. The safety of this medication in children and adolescents has not been adequately established, so its use is generally not recommended except in special cases. During treatment with this medication, dizziness or drowsiness may occur, necessitating caution when driving or operating machinery. Due to the presence of lactose, patients with lactose intolerance or related genetic disorders should not take this medication. In case of overdose, there is no specific antidote, so appropriate treatment and supportive care based on symptoms should be received, along with regular monitoring of liver function and muscle enzyme levels. This medication should be kept out of reach of children and it is advisable not to transfer it to other containers.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever associated respiratory disturbances, yellowing of skin or eyes (jaundice), generalized severe weakness, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

• Nasopharyngitis
• arthralgia
• headache
• increased ALT
• increased AST
• myalgia
• edema
• elevated bilirubin levels
• acneiform dermatitis
• pruritus

This medication should be stored in a well-closed container to avoid exposure to air or moisture, and the temperature should be kept between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3), 30 tablets/bottle