Roze K Tablet 10/20 mg

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/5 mg to 10/20 mg per day. The recommended initial dose is 10/5 mg once daily. The dose can be adjusted in patients requiring more LDL cholesterol reduction. After initiation of treatment or after dose adjustment, lipid levels should be checked at intervals of more than 4 weeks and adjusted accordingly.

This medication has been rarely reported to cause rhabdomyolysis, which can lead to serious muscle damage, therefore, if symptoms such as muscle pain or weakness occur, patients should consult a physician immediately. In particular, if there are risk factors such as severe infections, hypotension, major surgery or trauma, severe metabolic disorders, it may be necessary to temporarily discontinue or stop using the medication. Patients who are allergic to any components of this medication, have active liver disease, unexplained increases in liver enzymes, muscle diseases, severely impaired kidney function, or are pregnant or breastfeeding should not take this medication. Additionally, special caution is necessary for patients with moderate kidney impairment at risk for myopathy, hypothyroidism, familial history of muscle diseases, alcoholism, or those on certain drug combinations when taking this medication. This medication contains lactose, therefore patients with lactose intolerance should not take it. Patients with liver function impairment or those who consume alcohol excessively should have liver function tests done before taking this medication, and if symptoms of liver dysfunction appear during use, they should consult a healthcare professional immediately. Since this medication can affect blood enzyme levels, regular blood tests are recommended. Pregnant women or women of childbearing potential should avoid this medication as it could pose a risk to the fetus, and must use contraception while taking it; upon confirmation of pregnancy, the medication should be stopped immediately. Breastfeeding women should also avoid taking this medication for safety reasons. The safety of this medication in children and adolescents has not been sufficiently established, hence it is not recommended for them. Elderly patients are at higher risk of myopathy, therefore caution is necessary during use, although dose adjustments are generally not required. This medication may interact with other drugs, so patients must inform their healthcare provider, especially if taking anticoagulants, fibrate class drugs, certain antibiotics, antifungals, or immunosuppressants. If symptoms such as muscle pain, weakness, changes in urine color, jaundice, severe skin rash appear during use, patients should inform medical personnel immediately. This medication may cause dizziness that could affect driving or machine operation, therefore caution is advised. In case of overdose, as there is no specific antidote, appropriate treatment according to symptoms and liver and muscle enzyme tests will be required.

Serious side effects

Urticaria, edema, chest tightness, cold sweats, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, acute kidney failure, hepatitis, jaundice, acute hepatitis, hepatotoxicity, toxic hepatitis, severe muscle weakness, oculomotor weakness, dermatitis, severe allergic reactions, severe skin adverse reactions, dyspnea, respiratory problems, liver abnormalities (jaundice), serious neurological symptoms,

Mild side effects

• Nasopharyngitis
• dyspepsia
• headache
• dizziness
• constipation
• nausea
• abdominal pain
• dry mouth
• elevated liver enzymes
• increased serum lactate dehydrogenase

This medication may be sensitive to air or humidity, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way ensures the safety and effectiveness of the medication.

Appearance

Pink oval film-coated tablet

Package unit

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