Valsartan 5/80 mg Tablets (Amlodipine Besilate, Valsartan)

Adult dose

The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). If blood pressure is not adequately controlled, dosage adjustments can be considered as follows: ㆍ5/80 mg: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5 mg or valsartan 80 mg monotherapy. ㆍ5/160 mg:

Child dose

Safety and effectiveness for pediatric patients under 18 years of age have not been established, so use 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 upon confirmation of pregnancy. People who are allergic to the active ingredients or similar medications, pregnant or potentially pregnant women, nursing mothers, patients with severe kidney or liver diseases should not take this medication. Patients with low sodium or fluid levels may be at risk of hypotension, so their condition should be thoroughly checked before use, and during treatment, blood pressure and symptoms should be closely monitored. Patients with high potassium levels should have their potassium levels checked frequently when taking this medication with potassium supplements or potassium-sparing diuretics. Patients with renal artery stenosis or kidney transplant recipients may experience worsening kidney function, so careful monitoring of kidney status before and after administration is required. If symptoms of angioedema such as swelling of the face, lips, or tongue occur during treatment with this medication, it should be stopped immediately and medical advice sought. Patients with heart failure or myocardial infarction should be cautious when taking this medication as symptoms such as pulmonary edema may worsen, and kidney function must be evaluated. Patients with specific heart conditions such as acute myocardial infarction or aortic stenosis should use this medication with caution. This medication may increase the risk of hypotension, renal function deterioration, or hyperkalemia when taken with other antihypertensive medications or certain drugs, so consultation with a doctor is essential. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. Overdosage may lead to severe hypotension or heart rhythm abnormalities, so the prescribed dosage must be strictly followed, and any unusual symptoms should be reported to medical personnel immediately. Women who are pregnant or nursing are advised to avoid taking this medication, and it is not recommended for children as its safety has not been adequately established. For the elderly, normal dosing is recommended, but caution is necessary depending on kidney or liver function status. Regular checks, such as liver function tests or blood tests, are important during treatment to monitor for any side effects.

Serious side effects

Hives, severe swelling (edema), angioedema, tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, wheezing or difficulty breathing, asthmatic attacks, cough with fever accompanied by respiratory issues, yellowing of the skin or eyes (jaundice), profound weakness throughout the body, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances,

Mild side effects

• Headache
• dizziness
• drowsiness
• abnormal sensations
• vertigo
• tinnitus
• tachycardia
• palpitations
• syncope
• orthostatic hypotension

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best kept at room temperature between 1 to 30 degrees Celsius.

Appearance

Dark yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTP packaging × 2)