Medication info

Seviol Tablet 5/40 mg

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

MFDS item code 201803058 · 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 is administered once daily as one tablet, regardless of meals, with water. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg as monotherapy. - 10/20 mg: For patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg.
Children's dosage
The safety and efficacy in pediatric patients under 18 years of age have not been established.

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 control is not adequately achieved in patients with essential hypertension. These medications lower blood pressure by either dilating blood vessels or regulating blood pressure. They can effectively help stabilize blood pressure, particularly when monotherapy does not sufficiently control blood pressure. This can reduce the risk of cardiovascular complications due to hypertension. Hence, they are used to improve blood pressure in the treatment of essential hypertension.

Dosage and Administration

Adult dosage

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

Children's dosage

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

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be stopped immediately if pregnancy is confirmed. It should not be used in patients with known allergies to this drug's active ingredients or similar classes of drugs, pregnant or breastfeeding women, patients with severe liver impairment or specific heart diseases, and patients undergoing kidney dialysis. Patients with insufficient body fluid or sodium should be closely monitored as initial dosing may cause excessively low blood pressure, and appropriate measures should be taken if blood pressure drops too low. Due to its vasodilatory effects, caution is advised when using this medication in patients with specific heart diseases. Patients with weak kidney function or liver impairment should be cautious as this medication may affect the kidneys and liver. Side effects such as dizziness, headache, low blood pressure, indigestion, skin rash may occur during the use of this medication, and if any abnormal symptoms develop, it is advised to consult a physician. Particular attention is necessary if this medication is taken alongside potassium supplements or other antihypertensive medications as blood pressure may drop too low or potassium levels in the blood may rise. This medication should not be used during pregnancy, and it is advisable to switch to a different safe antihypertensive medication if planning to become pregnant. During breastfeeding, this medication may be transferred to breast milk and could affect the baby, so the decision to take it should be made carefully. Safety and efficacy in children under 18 years of age have not been established, therefore it is not recommended. In the elderly, where functions of the liver, kidneys, and heart may be diminished, dosage adjustments should be made with caution. In case of overdose, blood pressure may drop too low, and heart rate may increase, necessitating immediate medical attention. This medication should be stored in a cool, dry place away from direct sunlight and moisture, and should be kept out of reach of children. It is advisable to avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, angioedema, jaundice, acute renal failure, increased creatinine in blood, toxic epidermal necrolysis, angioedema, dizziness (reported as a serious adverse effect), exacerbation of cerebral infarction

Mild side effects

  • Dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • sensory abnormalities
  • reduced perception
  • vertigo
  • palpitations
  • rapid pulse
  • hypotension
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  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • epigastric pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • increased urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pits
  • fatigue
  • weakness
  • facial swelling
  • decreased potassium in blood
  • increased creatinine in blood
  • increased uric acid in blood

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain the storage temperature between 1°C to 30°C (room temperature). Proper storage helps to maintain the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Pale yellow round 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.