Rosuvastatin Calcium and Ezetimibe Tablets, 10/10 mg

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily. The recommended initial dose is 10/5 mg once daily. Patients requiring a greater reduction in LDL cholesterol can have their dosage adjusted. After initiation or dose adjustment, lipid levels should be checked at intervals of at least 4 weeks to adjust the dosage.

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to severe muscle damage. Therefore, if sudden muscle pain, weakness, or muscle cramps occur, consult a doctor immediately. Especially in cases of severe infection, hypotension, major surgery or trauma, or serious metabolic disorders where the risk of muscle damage is high, it may be necessary to temporarily discontinue or stop taking this medication. Patients with an allergy to any component of this medication, active liver disease, unexplained increases in liver enzymes, muscle disorders, severe kidney dysfunction, or women who are pregnant or may become pregnant or are breastfeeding should not take this medication. Furthermore, patients with moderate to severe renal impairment, hypothyroidism, a family history of muscle diseases, alcohol addiction, or those taking specific medications should be cautioned against high doses of this medication. This medication contains lactose, so patients with lactose intolerance or certain genetically inherited metabolic disorders should not take it. Patients with a history of alcohol addiction or liver disease, moderate to severe liver dysfunction, elderly patients, and those with a history of muscle disorders should be closely monitored when taking this medication. This medication may affect liver function, so regular liver function tests should be performed before and during treatment, and if symptoms of liver damage occur, usage should be discontinued immediately. During treatment with this medication, it is important to check for muscle damage through blood tests, and if muscle pain is severe or CPK levels are more than five times the upper limit of normal, the medication should be stopped. This medication may interact with other drugs, so patients taking other medications must inform their doctor or pharmacist, and caution is especially needed when used in combination with blood-thinning medications, certain antibiotics, antifungals, immunosuppressants, and fibrate medications. Women who are pregnant or planning to become pregnant should not take this medication, and during treatment, appropriate contraceptive methods should be used. Safety in children and adolescents has not been adequately established, so it is not recommended for this age group. Elderly patients are also at increased risk of myopathy, so caution is needed during use. In the case of an overdose, since there is no specific antidote, appropriate treatment and monitoring should be provided based on symptoms. This medication should be kept out of reach of children and should preferably not be transferred to another container.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urine abnormalities.

Mild side effects

• Headache
• joint pain
• muscle pain
• nasopharyngitis
• dizziness
• upper respiratory tract infection
• constipation
• nausea
• abdominal pain
• diarrhea

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The storage temperature should be kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness and ensure safe use.

Appearance

This medication is a pink, oval-shaped film-coated tablet.

Package unit

30 tablets/box [10 tablets/PTP (Alu-Alu) x 3]