Sevirol Tablet 5/20 mg

Adult dose

This medication is administered once daily at a dose of one tablet, regardless of meals, with water. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administered as olmesartan medoxomil 20 mg monotherapy.

Child dose

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

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, and cessation of use should occur immediately upon confirmation of pregnancy. It should not be used in patients who are allergic to the ingredients contained in this medication, pregnant or breastfeeding, have severe liver disease, aortic stenosis, biliary obstruction, are undergoing kidney dialysis, in a state of shock, or have certain diabetes conditions. Patients with insufficient body fluids or salts may experience low blood pressure; hence they should start the medication with careful monitoring of their condition. Caution should be exercised as sudden vasodilation may cause low blood pressure, especially in patients with severe aortic stenosis. For patients with severe coronary artery disease, the risk of angina or myocardial infarction may increase when this drug is used, requiring careful consideration. Patients with heart failure should use this medication carefully, and patients with impaired kidney function should monitor for changes in kidney function while using this medication. Patients with reduced liver function should be cautious as metabolism of this drug may slow down when taken. During use of this medication, side effects such as dizziness, headache, hypotension, orthostatic hypotension, edema, dyspepsia, skin rash, and more may occur. This medication may have serious effects on the fetus during pregnancy, so women who are planning to conceive or are currently pregnant must consult a doctor. If breastfeeding, the medication may be transmitted through breast milk and could produce side effects in infants, necessitating either cessation of breastfeeding or the drug. Safety and efficacy in children and adolescents under 18 years has not been established and is not recommended. In elderly patients, due to impaired kidney and liver function, drug concentrations in the body may increase; therefore, starting at low doses and careful monitoring is advisable. In case of overdose, symptoms such as low blood pressure and heart rhythm irregularities may occur, and immediate notification to medical staff and appropriate treatment is required. This medication should be stored in a tightly closed container away from moisture, heat, and direct sunlight, and should not be transferred to another container.

Serious side effects

Urticaria, angioedema, cholelithiasis, rhabdomyolysis, acute renal failure, increased blood creatinine, autoimmune hepatitis, jaundice, elevated liver enzymes, leukopenia, thrombocytopenia, toxic epidermal necrolysis, dizziness (serious adverse event), worsening of cerebral infarction, gum bleeding (serious adverse event), angioedema, hypotension, syncope, respiratory distress, difficulty breathing, headache (severe neurological symptom), generalized severe edema accompanied by increased blood pressure

Mild side effects

• Decreased libido
• dizziness
• headache
• drowsiness
• sensory disturbances
• reduced sensation
• vertigo
• palpitations
• rapid pulse
• hypotension

This medication should be stored in a tightly closed container to prevent air or moisture from entering, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

White round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)