X-One Tablet 5/80/5 mg

Adult dose

This medicine is taken orally once daily, one tablet with water. It is recommended to take it at the same time each day (e.g., before breakfast). The dosage should be individualized based on the efficacy and tolerance of the amlodipine/valsartan combination and rosuvastatin for each patient. Amlodipine/valsartan combination dosage: - 5/80 mg: Applicable for patients whose blood pressure is not controlled by standalone therapy with amlodipine 5 mg or valsartan 80 mg.

This medicine can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so if pregnancy is confirmed, it should be discontinued immediately. It should not be used in patients with allergies to its components or similar medications, in pregnant or breastfeeding women, or in patients with severe liver or kidney dysfunction. Caution is required for patients with lack of sodium or fluid in the body as hypotension may occur, and patients with hyperkalemia should frequently monitor their potassium levels. It should be used with caution in patients with renal vascular problems or those who have received a kidney transplant, and in patients with a history of angioedema. Patients with heart failure or post-myocardial infarction should closely monitor kidney function and heart status when administering this medicine, and patients with acute myocardial infarction should also be treated carefully. Elderly patients should start at a low dose and gradually increase the dose, and caution is advised for patients with impaired liver function. This medicine may cause muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis, so immediate consultation with a doctor is necessary if symptoms such as muscle pain or weakness occur. Additionally, side effects such as liver dysfunction, allergic reactions, hypotension, headache, dizziness, and edema may occur, and any unusual symptoms should be reported to healthcare providers. During the use of this medicine, interactions with other medications may occur, so it is essential to inform healthcare providers of any other medications being taken. Pregnant or breastfeeding individuals should not use this medicine, and women planning to become pregnant should use appropriate contraception methods. This medicine is not recommended for children and adolescents under 18 years of age as its safety and efficacy have not been established. In cases of overdose, symptoms such as hypotension and heart rate abnormalities may occur, so immediate medical attention is required.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and urination.

Mild side effects

• Peripheral edema
• warmth sensation
• increased ALT
• increased AST
• increased serum creatinine
• side pain
• throat pain
• dizziness
• sensory loss
• nasopharyngitis

This medicine should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to preserve the effectiveness of the medication and prevent degradation.

Appearance

Pale pink, oval, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle