Sebiten Tablets 5/20 mg

Adult dose

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

Child dose

The safety and efficacy of this medication in pediatric patients under the age of 18 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, so it must be discontinued immediately if pregnancy is confirmed. This medication should not be used by individuals who are allergic to the active ingredients or similar components, pregnant women, nursing mothers, patients with severe liver dysfunction, patients with severe aortic stenosis, patients with bile duct obstruction, patients undergoing renal dialysis, patients in a state of shock, certain diabetic patients, and patients with severely impaired kidney function. Careful observation is required when this medication is first administered to patients with deficient fluid or sodium levels, as hypotension may occur; appropriate management should be provided if hypotension occurs. Acute hypotension may rarely occur due to vascular dilation, so caution is necessary, especially in patients with severe heart valve disease. Patients with coronary artery disease or congestive heart failure should use this medication with caution, and patients with impaired kidney function should also be observed carefully. Since this medication is metabolized in the liver, it should be administered cautiously in patients with severe liver impairment. Side effects such as dizziness, headache, lowered blood pressure, cough, digestive disturbances, skin rashes, and edema may occur; if symptoms are severe, consult a physician. This medication should not be taken during pregnancy, and especially during the second and third trimesters, as it can pose serious risks to the fetus; patients planning to become pregnant or who are pregnant must consult a physician. Nursing mothers should discontinue breastfeeding or the medication since this drug may pass into breast milk. It is advisable not to use this medication in children under 18 years of age as its safety and efficacy have not been established in this population. Elderly patients should start with a low dose and adjust carefully due to the possibility of decreased kidney and liver function. In case of overdose, hypotension and impaired cardiac function may occur; immediate medical help should be sought for appropriate treatment. This medication should be stored in a tightly sealed container, away from moisture and heat, and out of reach of children.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, breathlessness or difficulty breathing, asthmatic attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output.

Mild side effects

• Dizziness
• headache
• orthostatic hypotension
• drowsiness
• paresthesia
• decreased sensation
• lightheadedness
• palpitations
• rapid heartbeat
• hypotension

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. The recommended storage temperature is between 1°C and 30°C at room temperature.

Appearance

White round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)