Sevitex Tablet 5/40 mg

Adult dose

The recommended dosage is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., morning). The recommended dosages are as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Olmesartan Medoxomil 20 mg monotherapy. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled with Olmesartan Medoxomil 20 mg monotherapy.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age.

This drug can cause serious harm to the fetus and newborn if taken during the 2nd and 3rd trimester of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Should not be used in patients with allergy to any component of this drug, those who are pregnant or breastfeeding, and in cases of severe liver impairment, aortic stenosis, bile duct obstruction, or renal dialysis. In patients with fluid or salt depletion, low blood pressure may occur at the start of treatment, so the patient's condition should be carefully monitored. Caution is especially required in severe aortic stenosis patients, as vascular dilation may lead to hypotension. Careful use is needed in patients with severe obstructive coronary artery disease or congestive heart failure, and monitoring for the exacerbation of heart failure is required. Changes in renal function may occur in patients with impaired renal function, therefore caution is needed. Patients with liver impairment may have a slower metabolism for the drug, hence caution is required. This medication may cause side effects such as dizziness, headache, hypotension, edema, nausea, rash, and if symptoms persist, consultation with a physician is recommended. Particularly, since blood potassium levels may rise, potassium supplements or potassium-sparing diuretics should be monitored periodically for blood potassium concentration when used together. The use of this drug should be avoided during pregnancy, and if there are plans for pregnancy or if pregnancy is confirmed, consulting with a doctor is mandatory. In nursing mothers, as this drug can be transmitted through breast milk, it is recommended to either stop breastfeeding or discontinue the medication. Safety and efficacy in children under 18 years of age have not been established, so it is not recommended. Elderly patients over the age of 65 should start from a low dose, considering renal and liver function, and closely monitor their condition. Overdose may cause symptoms such as hypotension and tachycardia, requiring immediate medical attention.

Serious side effects

Hives, angioedema, acute renal failure, increased serum creatinine, autoimmune hepatitis, jaundice, elevated liver enzymes, leukopenia, thrombocytopenia, toxic epidermal necrolysis, severe dizziness (one of the serious adverse events), exacerbation of cerebral infarction, gum bleeding (one of the serious adverse events)

Mild side effects

• Hyperkalemia
• decreased libido
• dizziness
• headache
• orthostatic hypotension
• drowsiness
• paresthesia
• a decrease in sensitivity
• syncope
• vertigo

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets / box [(10 tablets / PTP × 3)]