Medication info

Seviol Tablet 5/20 mg

Prescription medicationExpired
Ingredient · strength
Amlodipine Besylate›Strength being verifiedOlmesartan Medoxomil›Strength being verified
Manufacturer / importer
(주)중헌제약
Appearance
Round white film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Expired

MFDS item code 201803056 · Approved 2018.07.24

This product's status changed to Expired on 2023.07.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who uses it
Adults · Children
Adult dosage
This medication should be taken once daily in one tablet with water, regardless of meals. It is recommended to take it at the same time each day, such as in the 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 alone.
Children's dosage
The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Amlodipine or Olmesartan Medoxomil is used when blood pressure is not adequately controlled in essential hypertension, which has no known cause. These drugs help control blood pressure by dilating blood vessels or lowering blood pressure. Proper management of blood pressure reduces the burden on the heart and blood vessels, thereby decreasing the risk of cardiovascular diseases. Thus, these drugs are effective in improving blood pressure control and treating hypertension.

Dosage and Administration

Adult dosage

This medication should be taken once daily in one tablet with water, regardless of meals. It is recommended to take it at the same time each day, such as in the 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 alone.

Children's dosage

The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. It should not be used if there is an allergy to any of the ingredients, or if the patient is pregnant or breastfeeding, has severe liver impairment, aortic stenosis, bile duct obstruction, is undergoing dialysis, is in a state of shock, or has certain types of diabetes. Caution should be exercised when administering this medication to patients with hypotension due to lack of fluid or salt, patients at risk of rapid blood vessel dilation, patients with severe obstructive coronary artery disease, congestive heart failure, impaired kidney function, and patients with liver impairment; careful monitoring of their condition is necessary at the start of treatment. While taking this medication, various side effects such as dizziness, headache, hypotension, orthostatic hypotension, palpitations, nausea, vomiting, rash, and edema may occur, so if any abnormal symptoms appear, the patient should consult a doctor immediately. Although this medication is different from beta-blockers, caution should be taken when taken with other antihypertensive drugs, as it may lower blood pressure too much; particularly, kidney function or electrolyte status should be monitored regularly. Due to the potential risk to the fetus during pregnancy, patients planning to become pregnant or those who are pregnant should consult a doctor, and breastfeeding mothers should also carefully consider whether to take this medication, as it can pass into breast milk and affect the baby. 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 elderly patients, renal and hepatic functions may be impaired, so starting with a lower dose and closely monitoring for side effects is recommended. In case of overdose, severe hypotension and symptoms due to vascular dilation may occur, so appropriate treatment should be sought immediately at a hospital. This medication should be stored away from light and moisture, out of reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • facial edema
  • angioedema
  • cholelithiasis
  • exacerbation of cerebral infarction
  • gum bleeding
  • severe edema
  • dizziness
  • tachycardia
  • hypotension
Show 21 more
  • bradycardia
  • acute renal failure
  • toxic epidermal necrolysis
  • myocardial infarction
  • stroke
  • sudden cardiac death
  • cerebral infarction
  • headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • increased blood pressure
  • significant decrease in urine output
  • jaundice
  • liver abnormalities
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory distress
  • cough
  • chest tightness

Mild side effects

  • Hyperkalemia
  • decreased libido
  • dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • sensory changes
  • decreased sensation
  • syncope
  • vertigo
Show 26 more
  • palpitations
  • rapid pulse
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • polyuria
  • erectile dysfunction
  • peripheral edema
  • edema
  • pit edema
  • fatigue
  • weakness
  • facial edema
  • decreased blood potassium
  • blood creatinine

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to keep it at room temperature, ideally between 1 degree and 30 degrees Celsius, avoiding extremes of temperature.

Appearance and packaging

Appearance

Round white film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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.