Medication info
Sebikan Tablet 5/20 mg

Sebikan Tablet 5/20 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
White round film-coated tablets
Packaging
28 tablets/PTP [(14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 201907788 · Approved 2019.11.07 · Insurance code 623006330

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered as one tablet once daily, regardless of meals, and it is recommended to take it at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Administered to patients not adequately controlled by olmesartan medoxomil 20 mg.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension who do not achieve sufficient control with monotherapy using amlodipine or olmesartan medoxomil. This helps stabilize blood pressure, preventing cardiovascular complications and improving health.

How to take

Adult dose

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

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, particularly in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Patients with allergies to this drug's active ingredients or similar substances, pregnant or nursing women, individuals with severe liver dysfunction, patients with severe aortic stenosis, biliary obstruction, renal dialysis patients, patients in shock, and certain diabetic patients should not use this medication. Patients with hypotension due to lack of fluids or salt may experience initial hypotension, so their condition should be closely monitored, and appropriate measures should be taken if hypotension occurs. Also, sudden vasodilation can lead to hypotension, so special caution is required for patients with aortic stenosis. Patients with severe obstructive coronary artery disease should be cautious as the risk of angina or myocardial infarction may increase with this medication. Caution should be exercised in patients with heart failure, and patients with impaired renal function may experience changes in kidney function while taking this drug. In patients with liver dysfunction, metabolism of this drug may be slowed, necessitating dosage adjustments. While taking this medication, symptoms such as dizziness, headache, hypotension, edema, gastrointestinal symptoms may appear, so patients should consult their doctor if any unusual symptoms occur. This medication should be avoided during pregnancy due to risks to the fetus, and if breastfeeding, mothers should discontinue either breastfeeding or taking this medication as adverse reactions may occur in infants. It is not recommended for children under 18 years as safety and efficacy have not been established. Elderly patients may be more sensitive to this drug, so treatment should start at a low dose with dosage adjusted considering kidney and liver function. In cases of overdose, hypotension and decreased cardiac function may occur, necessitating immediate medical attention and continuous monitoring of blood pressure and cardiac status. This medication should be stored in a cool, dry place, avoiding moisture and heat, and kept out of reach of children; transferring to other containers should be avoided. Before starting this medication, patients must consult with a doctor or pharmacist regarding potential interactions with other medications they are currently taking.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, severe allergic reactions, severe skin reactions, yellowing of the skin or eyes (jaundice), liver dysfunction (jaundice), acute renal failure, severe edema associated with increased blood pressure, serious neurological symptoms (worsening of cerebrovascular accident), angioedema, increased creatinine levels in the blood, hematuria, toxic epidermal necrolysis, autoimmune hepatitis, leukopenia, thrombocytopenia, respiratory distress, asthma attacks, cough.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • decreased libido
  • orthostatic hypotension
  • decreased potassium levels
  • increased creatinine levels
  • increased uric acid levels
  • increased gamma-glutamyl transferase
  • fatigue
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  • rash
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • muscle tension
  • limb pain
  • low back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • pitting edema
  • facial swelling
  • increased potassium levels in the blood
  • hematuria
  • hair loss
  • itching
  • flushing
  • palpitations.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Maintaining the storage temperature between 1 degree and 30 degrees Celsius is important. Doing so will help preserve the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

28 tablets/PTP [(14 tablets/PTP x 2)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.