XV Tablet 5/80 Milligrams

Adult dose

The recommended dosage is one tablet once daily, with or without food, taken with water. It is recommended to take it at the same time every day (e.g., morning). 5/80 Milligrams: Given to patients whose blood pressure is not adequately controlled by amlodipine 5 milligrams or valsartan 80 milligrams monotherapy. 5/160 Milligrams: Given to patients whose blood pressure is not adequately controlled by amlodipine 5 milligrams or valsartan 160 milligrams monotherapy.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, hence administration of this drug is not recommended.

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters, so it must be discontinued immediately if pregnancy is confirmed. Patients allergic to any of the ingredients in this medication or similar classes of drugs, patients with severe renal or hepatic dysfunction, pregnant or breastfeeding women, and patients with a history of certain cardiac diseases or angioedema should not take this drug. Patients with a deficiency of sodium or body fluids should manage their condition before taking this drug and must closely monitor blood pressure and symptoms during use. If hypotension occurs, they should lie down and rest immediately and seek appropriate medical treatment if necessary. Patients with high potassium levels should have their potassium levels checked frequently when taking this drug with potassium supplements or potassium-sparing diuretics, and caution is also needed for patients with impaired renal function. Patients with renal artery stenosis or kidney transplant recipients should closely monitor renal function when using this drug and should stop taking it immediately if symptoms of angioedema occur. Patients with heart failure or following myocardial infarction should regularly check renal function and blood pressure while taking this medication, and it should be used cautiously in severe heart failure patients. When used in combination with other blood pressure medications, this drug may increase the risk of hypotension, worsening renal function, hyperkalemia, etc., so blood pressure and blood tests must be carefully monitored according to the physician's instructions. Caution is advised while driving or operating machinery as dizziness or fatigue may occur, especially when starting the medication or changing the dose. In case of overdose, blood pressure may drop suddenly, requiring immediate medical attention, and in severe cases, it may lead to shock, necessitating emergency treatment. This drug is not recommended for children under 18 years of age as its safety and efficacy have not been established for this population. Elderly patients may be given a similar dose as adults, but should be carefully monitored considering their physical condition.

Serious side effects

• Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
• Severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, severe skin reactions
• Shortness of breath or difficulty breathing, asthma attacks, coughing with fever and aberrant respiration
• Skin or eyes turning yellow (jaundice), extreme lethargy, liver abnormalities (jaundice)
• Sudden and very severe headache

Mild side effects

• Headache
• dizziness
• drowsiness
• paresthesia
• lightheadedness
• tinnitus
• tachycardia
• palpitations
• syncope
• orthostatic hypotension

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to effectively maintain the drug’s efficacy and safety.

Appearance

Dark yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTP x 2)