X1 Tablet 5/80 mg

Adult dose

The recommended dosage for adults is 1 tablet once daily. It should be taken with water, regardless of meals, and preferably at the same time each day (e.g., in the morning). The 5/80 mg dosage is administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or valsartan 80 mg. The 5/160 mg dosage is used for patients not adequately controlled by monotherapy with amlodipine 5 mg or valsartan 160 mg.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, and the use of this medication is not recommended.

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnant. It should not be taken by individuals who have allergies to its active ingredients or similar components, pregnant women, patients with severe kidney or liver diseases, or certain diabetic patients. Patients with fluid or sodium deficiency should manage their condition well before taking this medication, and blood pressure and condition should be closely monitored during use. Patients with high potassium levels should be cautious when taking this medication along with potassium-containing drugs or supplements, and regular blood tests to check potassium levels are necessary. Patients with narrowed renal arteries or those who have had kidney transplants require careful monitoring after taking this medication due to potential effects on kidney function. If symptoms of angioedema appear, discontinue use immediately and do not take it again. Patients with heart failure or myocardial infarction should also closely monitor kidney function and symptoms while taking this medication. As with other vasodilators, caution is needed for patients with certain heart conditions such as aortic stenosis. Combining this medication with angiotensin receptor blockers, ACE inhibitors, or aliskiren can increase the risk of hypotension, worsening kidney function, and hyperkalemia, so combination therapy should be avoided or strictly monitored. Dizziness or fatigue may occur while taking this medication, so caution is needed when driving or operating machinery. This medication may interact with other drugs, particularly potassium supplements, diuretics, NSAIDs, certain antibiotics, simvastatin, and CYP3A4 inhibitors, so consulting with a healthcare professional is advised when taking these together. Breastfeeding women are not recommended to take this medication, and its safety and efficacy have not been sufficiently established for children under 18, so its use is not recommended in this age group. In case of overdose, symptoms like hypotension and cardiac function abnormalities may occur, so immediate medical attention is required.

Serious side effects

Urticaria, severe swelling (edema), angioedema, angioedema (including swelling of the larynx and glottis), vasculitis, Stevens-Johnson syndrome, serious skin reactions, hepatic enzyme elevation, hepatitis, jaundice, severe allergic reactions, kidney failure, decreased kidney function, acute kidney failure, severe skin adverse reactions, severe edema or urination issues, serious neurological symptoms, thrombocytopenia, leukopenia, confusion, visual disturbances

Mild side effects

• Nasopharyngitis
• influenza
• visual disturbances
• anxiety
• headache
• dizziness
• drowsiness
• orthostatic dizziness
• sensory abnormalities
• vertigo

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 30 tablets/bottle, 90 tablets/bottle